KnowItAlz.com

Alzheimer's Blog

Current Clinical Trials

Alzheimer’s Disease Genetics Study

This study is currently recruiting patients.
Verified by National Institute on Aging (NIA) November 2006

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00064870

Purpose

shutterstock_3053554.jpgThe purpose of the Alzheimer’s Disease Genetics Study is to identify the genes that are responsible for causing Alzheimer’s Disease (AD). One of the ways in which the risk factor genes for late onset AD can be investigated is by identifying and collecting genetic material from families with multiple members diagnosed with late onset (over 60 years of age) AD. Families meeting the criteria will have a sibling pair diagnosed with AD with an onset of age 60 or older and at least one other affected or unaffected relative willing to participate. Families will be evaluated for a medical diagnosis and other factors. If eligible, blood samples will be collected to establish cell lines. If one of the identified family members is deceased, DNA will be extracted and stored from autopsy samples. Local sites will collect clinical and demographic data from the families and will send coded data (without identifiers) to the National Cell Repository for Alzheimer’s Disease (NCRAD) at Indiana University. Persons interested in registering to participate in this study can call the toll-free NCRAD number 1-800-526-2839 for more information. Local study sites are located all over the United States, and arrangements may be made for eligible families who do not live near a participating site
Condition
Alzheimer Disease
Late Onset Alzheimer Disease

Official Title: Alzheimer’s Disease Genetics Study

Further study details as provided by National Institute on Aging (NIA):
Total Enrollment: 3000

Study start: June 2002; Expected completion: May 2008

The purpose of the Alzheimer’s Disease Genetics Study is to identify the genes that are responsible for causing Alzheimer’s Disease (AD). One of the ways in which the risk factor genes for late onset AD can be investigated is by identifying and collecting genetic material from families with multiple members diagnosed with late onset (over 60 years of age) AD. Families will be evaluated for a medical diagnosis and other factors. If eligible, blood samples will be collected from the participants to establish cell lines. If one of the identified family members is deceased, DNA will be extracted and stored from autopsy samples. Qualifying families will have a minimum of 3 members participating in the study: a sibling pair diagnosed with AD with an onset at age 60 or older and a third member who must have an age of onset greater than 50, if affected, and 60 or older, if unaffected. The goal is to recruit 1,000 families in three years. This research will include a collection of samples from ethnic/minority populations and other special populations, including African Americans, the Amish, Hispanics, Asian Americans, and Japanese-Americans. Persons interested in registering to participate in this study can call the toll-free NCRAD number 1-800-526-2839 for more information. Local study sites are located all over the United States, and arrangements may be made for eligible families who do not live near a participating site.

Local sites, including the NIA-sponsored Alzheimer’s Disease Centers, will collect clinical and demographic data from these families, and the sites will send coded data (without identifiers) to the National Cell Repository for Alzheimer’s Disease (NCRAD) at Indiana University. The biological samples and data from these families will be available to qualified researchers, who must sign a Materials Transfer Agreement (to protect the privacy rights of participants in this study and to agree to share the results of genetic analyses) before receiving DNA and data. An oversight committee known as the Cell Bank Advisory Committee (CBAC) and the Coordinator of the NIA Alzheimer’s Disease Genetics Study, Richard Mayeux, MD, Columbia University, will review and monitor the process of family identification and enrollment, data collection, and the establishment of cell lines. This repository of DNA and cell lines was developed in hopes of discovering risk factor genes that contribute to late onset AD.

Eligibility

Ages Eligible for Study: 50 Years and above, Genders Eligible for Study: Both
Criteria

Inclusion Criteria:

Families meeting the criteria will have a sibling pair diagnosed with AD with an onset age of 60 or older and at least one other affected or unaffected relative willing to participate. There must be at least three individuals in the family for whom biological samples are available.

  1. First Family Member (proband):
    • A diagnosis of Definite or Probable AD by NINDS-ADRDA criteria.
    • Age at onset or age at diagnosis of > 60 years.
    • Individual was evaluated in person and diagnosed by an NIA-funded Alzheimer’s Disease Center.
    • Biological samples available.
  2. Second Family Member:
    • A sibling of the proband.
    • A diagnosis of Definite AD, Probable AD, or Possible AD by NINDS-ADRDA criteria.
    • Age of onset or age at diagnosis > 60 years.
    • Preferred that individual be evaluated in person, but a diagnosis by medical records (including dementia testing) and telephone interview is acceptable.
    • Biological samples available.
  3. Third Family Member:
    • A sibling, half-sibling, parent, offspring, aunt, uncle, or first cousin of the proband.
    • A diagnosis of Definite AD, Probable AD, or Possible AD by NINDS-ADRDA criteria; a diagnosis of questionable dementia; mild cognitive impairment; or unaffected by AD.
    • If affected, age of onset of dementia or age at diagnosis > 50 years.
    • If unaffected, must be > 60 years.
    • Preferred that the individual be evaluated in person, but a diagnosis (including cognitive testing) by medical records/telephone interview is acceptable.
    • Biological samples available.
  4. Biological samples:
    • Fresh blood, or
    • Immortalized lymphoblastic cell lines, or
    • 3-5 grams of frozen cerebral cortex; fixed samples are not accepted

Exclusion Criteria:

  • Does not meet inclusion criteria
  • Has a known mutation in an early onset AD autosomal dominant gene
  • Member of a family that was included in the National Institute of Mental Health AD Genetics Sib Pair collection.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00064870

Jessica Leatherland, NCRAD 1-800-526-2839 alzstudy@iupui.edu
Valerie P. Parks, NCRAD 317-278-9546 alzstudy@iupui.edu
United States, Indiana
Participants are being recruited from all over the United States, Nationwide, Indiana, United States; Recruiting

Michele Goodman 800-526-2839 alzstudy@iupui.edu
Spanish-speaking Contact 800-243-5828
vcs2103@columbia.edu
Study chairs or principal investigators
Tatiana M. Foroud, PhD, Principal Investigator, National Cell Repository for Alzheimer’s Disease (NCRAD), Indiana University

More Information

NCRAD: the National Cell Repository for Alzheimer’s Disease

Study ID Numbers: IA0042; NIH grant U24 AG21886
Last Updated: November 7, 2006
Record first received: July 14, 2003
ClinicalTrials.gov Identifier:
NCT00064870
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on May 23, 2007

 


MRI of Alzheimer’s Disease Imaging Amyloid Plaques in Persons With and Without Memory Problems

This study is currently recruiting patients.
Verified by National Institutes of Health Clinical Center (CC) December 2006

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00413621

Purpose

The study will investigate the possibility of detecting early signs of Alzheimer’s disease using magnetic resonance imaging (MRI). If plaques, types of damage, can be imaged by MRI, the procedure could be used in clinical trials and may also help in the clinical diagnosis of patients. Alzheimer’s disease, a progressive disease, is a major cause of functional disability and institutionalization, affecting 4.5 million people in the United States, a number that will more than triple by 2030 as the population ages.

Patients ages 55 to 90 who have mild symptoms of Alzheimer’s disease and who are in good health may be eligible for this study. Twenty patients will be recruited from Johns Hopkins’ Alzheimer’s Disease Research Center. There will also be a control group of 20 people without the disease.

Healthy patients and volunteers will have a clinical MRI brain scan and a neurological examination at Johns Hopkins Hospital before the 7T MRI scan. Also, patients will have a Mini-Mental State Examination, a standardized test to evaluate memory, done at Johns Hopkins within 4 weeks of the 7T MRI. This study uses a device situated at the NIH Bethesda campus that operates at a high magnetic field strength of 7 Tesla, that is, the unit used to measure the strength of a strong magnet. The Food and Drug Administration has categorized MRI up to 8 Tesla as not a significant health risk. MRI scanning is routinely done at magnetic field strengths up to 4T. MRI images are created through the use of a large magnet and radio waves. During the procedure, patients lie on a table moved into a strong magnetic field. They are asked to lie still but can easily hear and speak to research staff. A respiratory belt is placed around the chest, and a finger probe is placed on the finger, to monitor breathing and heart rate. For obtaining a better picture, a special lightweight coil may be placed on or around the patient’s head. The scan takes from 20 minutes to 2 hours, with most scans at 45 to 90 minutes. Due to limited experience with the use of 7T MRI and its investigational nature, patients will be asked to complete a questionnaire immediately after the study. They will be asked about their comfort level and if they experienced unusual sensations. Answers will be reviewed with patients by an experienced MRI investigator to get details of any unusual sensations reported. If patients experience unusual sensations, they are followed up by phone within 24 hours.

This study will have no direct benefit for participants. However, knowledge gained may improve methods of tracking the course of Alzheimer’s disease.

Condition
Alzheimer’s Disease

MedlinePlus related topics: Alzheimer’s Caregivers; Alzheimer’s Disease
Genetics Home Reference related topics: Alzheimer disease

Study Type: Observational
Study Design: Natural History

Official Title: MRI of Alzheimer’s Disease Imaging Amyloid Plaques in Persons With and Without Memory Problems

Further study details as provided by National Institutes of Health Clinical Center (CC):
Total Enrollment: 40

Study start: December 2006

Objective:

The objective of the proposed pilot study is to investigate the possibility of detecting early signs of Alzheimer’s Disease (AD) using high field (7T) MRI. If plaques can be imaged by MRI, the procedure could be used as a measure of efficacy in clinical trials of AD, and replace more invasive methods such as positron emission tomography (PET). This procedure might also be helpful in the clinical diagnosis of patients.

Study Population:

The target population is a group of 20 Alzheimer’s patients with mild cognitive impairment. As reference, an age-matched control group (n=20) will be recruited from the normal adult population.

Design:

Our working hypothesis is that high resolution MRI at 7T allows detection of amyloid plaques in AD. To test this hypothesis, subjects from AD and control population will each undergo an MRI at 7T to image brain structure at high resolution. Brain cortical structures will then be compared between the two groups and investigated for abnormalities.

Outcome Measure:

As outcome measure of this study, it will be determined if (sub) cortical plaques typical of AD are detectable with high field MRI.

Eligibility

Ages Eligible for Study: 55 Years – 90 Years, Genders Eligible for Study: Both Accepts Healthy Volunteers

Criteria
  • INCLUSION CRITERIA:
  • Any neurologically and psychiatrically normal, male or female, healthy volunteer ages 55-90 years old. Participants must be capable of understanding the procedures and requirements of this study and subjects must be willing to sign an informed consent document. Normal controls will demonstrate normal function in daily life, based on the Clinical Dementia Rating Scale (CDR). The CDR is administered annually to all JHADRC participants.
  • AD patients will be required to meet the NINCDS/ADRDA criteria for AD. All patients must be mildly impaired. Severity will be measured by the Mini-Mental State Exam (MMSE) and only patients with an MMSE score of 20 – 26 will be included. They must be able to give informed consent.

EXCLUSION CRITERIA:

  • Inability to cooperate.
  • A subject will be excluded if he/she has a contraindication to MR scanning such as the following: claustrophobia, pregnancy, aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings) or insulin pump.
  • Subjects who underwent brain surgery, or other neurological disease (e.g., stroke, Parkinson’s disease, significant brain vascular disease, brain trauma).
  • Evidence of cerebrovascular risk factors, including diabetes, arrhythmias, and lacunar infarcts seen on MRI.
  • History of vertigo, seizure disorder, middle-ear disorder, and double vision.
  • Active major psychiatric illness.
  • Dental work such as ferromagnetic crowns or bridges.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00413621

Andrea Nelson, R.N. Not Listed anelson18@jhmi.edu
United States, Maryland
Johns Hopkins University, Baltimore, Maryland, 21205, United States; Recruiting

More Information

NIH Clinical Center Detailed Web Page

Publications

Breitner JC, Wyse BW, Anthony JC, Welsh-Bohmer KA, Steffens DC, Norton MC, Tschanz JT, Plassman BL, Meyer MR, Skoog I, Khachaturian A. APOE-epsilon4 count predicts age when prevalence of AD increases, then declines: the Cache County Study. Neurology. 1999 Jul 22;53(2):321-31. Erratum in: Neurology 2000 Jul 12;55(1):161-2.

Study ID Numbers: 070050; 07-N-0050
Last Updated: April 27, 2007
Record first received: December 19, 2006
ClinicalTrials.gov Identifier:
NCT00413621
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on May 23, 2007

 


Prevention of Alzheimer’s Disease by Vitamin E and Selenium (PREADVISE)

This study is currently recruiting patients.
Verified by National Institute on Aging (NIA) March 2007

Sponsors and Collaborators: National Institute on Aging (NIA)

Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00040378

Purpose

The Prevention of Alzheimer’s Disease by Vitamin E and Selenium (PREADVISE) prevention trial is an important addition to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). As a prevention trial, PREADVISE is trying to find out if taking selenium and/or Vitamin E supplements can help to prevent memory loss and dementia such as Alzheimer’s disease.
Condition Intervention Phase
Alzheimer Disease
Drug: Vitamin E
Drug: Selenium
Phase III

MedlinePlus related topics: Alzheimer’s Caregivers; Alzheimer’s Disease
Genetics Home Reference related topics: Alzheimer disease

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Efficacy Study

Official Title: Prevention of Alzheimer’s Disease by Vitamin E and Selenium (PREADVISE)

Further study details as provided by National Institute on Aging (NIA):
Total Enrollment: 10400

Study start: May 2002; Expected completion: August 2013

Studies show that increased oxidative stress (from excess free radicals) may damage brain cells and is linked with Alzheimer’s disease (AD). Many studies show increased oxidation of brain lipids (fats), proteins, carbohydrates (sugars) and DNA in AD. Although the causes of AD are not known, it is believed that oxidative stress is part of what damages brain cells in AD and probably other brain diseases. Animal and tissue culture studies of vitamin E and selenium suggest that they can protect brain cells from damage. This research study is being done to see how safe and effective vitamin E and selenium may be in preventing AD and other brain illnesses. These illnesses are more common in people over the age of 60 to 65. A potential benefit of participating in the PREADVISE study is that early detection of memory changes can lead to early diagnosis and treatment. Also, some participants may decrease their risk of getting AD if the supplements are effective. The findings of this study may also help in the research and understanding of AD.

Only participants who are taking part in the SELECT study (a study that looks at the use of vitamin E and selenium for preventing prostate cancer) may apply to participate in the PREADVISE study about how useful vitamin E and selenium might be for preventing memory changes with age (including Alzheimer’s disease and other disease that can affect the brain). African American and Hispanic men who are age 60 or older may take part. Men of other ethnic groups aged 62 or older may take part. The SELECT doctors or staff will review the applicant’s medical history and drugs to verify that they have no conditions that would exclude them from this study. About 10,000 men will take part in this study.

The PREADVISE study examinations will be done during the participant’s annual SELECT visit at the clinic where the SELECT studies are being conducted. There will be one study visit for each year the participants are in SELECT (7 to 12 visits). Each visit for PREADVISE will consist of a brief screening of the participant’s memory, and an update (if any) of the participant’s family history of dementia and medications. If memory changes are suggested by the brief memory screen, the participant will be asked to take a longer memory screen to further evaluate the potential for memory changes. If the longer memory screen also suggests problems with the participant’s memory, the participant will be asked to see his family doctor or a PREADVISE doctor for a more complete medical exam to find the possible causes of the memory change. Results of the doctor’s medical exam, with the consent of the participant, will be sent to the PREADVISE doctors for their review to help with the diagnosis. Results of the memory checks will not be given to the participants. However, if the participant does have a medical workup for memory changes, this information will be given to the family doctor after the medical workup is completed. A portion of the blood sample that was taken when the participant entered SELECT might be analyzed and tested for a genetic risk factor associated with Alzheimer’s disease, called Apolipoprotein E (ApoE). The results of this test will be used for research purposes only.

Eligibility

Ages Eligible for Study: 60 Years – 90 Years, Genders Eligible for Study: Male Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Participating in SELECT Prevention study;
  • 62 years or older if other ethnic origin, or 60 years or older if African-American or Hispanic;
  • General good health with no neurological or psychiatric illness.

Exclusion Criteria:

The SELECT doctors or staff will review the PREADVISE applicants’ medical history and drugs to verify that they have no condition(s) that would exclude them from this study. The participant must not have any of the following neurological conditions based on self report (were told by a physician):

  • Alzheimer’s disease, or any other form of dementia such as Pick’s disease, dementia with Lewy bodies, frontotemporal dementia, vascular dementia, significant cognitive and motor impairment from a stroke or corticobasal degeneration;
  • Huntington’s disease, epilepsy, Parkinson’s disease, brain tumor, multiple sclerosis, manic-depressive disorder, or schizophrenia;
  • The participant must not have had a head injury with prolonged loss of consciousness (over 30 minutes) within the past five years;
  • The participant must not have a current alcohol or substance abuse diagnosis, or must have been treatment free for the past 24 months;
  • The participant must not have had a diagnosis of depression or anxiety disorder in the past 4 months and must not currently be under treatment for depression or anxiety disorder. [A participant who was previously diagnosed with depression or anxiety disorder but completed treatment more than four months ago is eligible.];
  • The participant must not currently use of any of the following medications: Aricept, Cognex, Exelon, Reminyl, or Hydergine;
  • The participant must not have blindness, deafness, language difficulties or any other disability that may prevent completion of the memory screen.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00040378

Cecil R. Runyons 1-859-257-1412 Ext. 235 preadvise@lsv.uky.edu
United States, Alabama
University of Alabama at Birmingham Preventive Medicine, Birmingham, Alabama, 35294-4410, United States; Recruiting

Isabelle Joffrion, RN 205-934-9502 ijoffrion@dopm.uab.edu

United States, Alaska
Providence Alaska Medical Center, Anchorage, Alaska, 99508, United States; Recruiting

Kathleen W. Shue, RN, OCN 907-261-3109 kwilsack@provak.org

Alaska Regional Hospital, Anchorage, Alaska, 99508, United States; Recruiting

Judith Link 907-264-1579 judith.link@hcahealthcare.com

United States, California
VA Medical Center, Loma Linda, California, 92354-3866, United States; Recruiting

Kimberly A. Bluff, RN 909-558-3107 bluffk@lom.med.va.gov

Santa Rosa Memorial Hospital Regional CCOP, Santa Rosa, California, 95403, United States; Recruiting

Kris Hartigan, RN, OCN 707-521-3820

Harbor UCLA Medical Cemter, Torrance, California, 90502-2064, United States; Recruiting

Marie Jackson, MBA 310-222-5339

Lionel B. Katchem, Upland, California, 91786, United States; Recruiting

Arlene J. Katchem, CRA 909-373-0381

University of California, San Diego – Chula Vista, Chula Vista, California, 91910, United States; Recruiting

Clydene Nee 858-622-5747

Glendale Memorial Hospital, Glendale, California, 91204, United States; Recruiting

Mary Eichenhofer, RN 818-409-7653

University of California, San Diego, La Jolla, California, 92037-1709, United States; Recruiting

Clydene Nee 858-622-5747

VAMC Long Beach, Long Beach, California, 90822, United States; Recruiting

Francoise M. Toussaint-Jones, MA 562-826-5755

Northridge Hospital Medical Center, Northridge, California, 91328, United States; Recruiting

Diane M. Killian, CCRA 818-885-5458

United States, Colorado
Rocky Mountain CC/Poudre Valley Hospital, Fort Collins, Colorado, 80524, United States; Recruiting

Linda M. Hadlow, RN, MS 970-495-7322

United States, District of Columbia
DC United MBCCOP, Washington, DC, District of Columbia, 20060-0001, United States; Recruiting

Dionne Thorne, MPH 202-865-5398

George Washington University Medical Center, Washington, DC, District of Columbia, 20037, United States; Recruiting

Maria-Lourdes Caparas, MPH 202-496-6464

Sibley Memorial Hospital, Washington, DC, District of Columbia, 20016, United States; Recruiting

Sheila Evans 202-243-2320 sevans@sibley.org

United States, Florida
Baptist Medical Center, Jacksonville, Florida, 32207-8560, United States; Recruiting

Sally Coxwell, RN 904-202-7073 sallybrci@aol.com

United States, Georgia
Kaiser Southeast Permanente Medical Group, Tucker, Georgia, 30084, United States; Recruiting

Carol A. Mayers 770-496-3634

United States, Iowa
Bliss Cancer Center/McFarland Clinic/Mary Greely MC, Ames, Iowa, 50010, United States; Recruiting

Janet C Mannetter, RN 515-239-2621 mannetter@mgmc.com

Cedar Rapids CCOP, Cedar Rapids, Iowa, 52403, United States; Recruiting

Kathy Fleming, RN, MSN 319-363-2690

Genesis Medical Center, Davenport, Iowa, 52804, United States; Not yet recruiting
Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting

Mary Loots, RN 515-244-7586

Siouxland Hematology-Oncology Associates, Sioux City, Iowa, 51101, United States; Recruiting

Pamela J. Mears, RN, OCN 712-252-9334

United States, Kansas
Stormont-Vail Health Care/Cotton O’Neil Clinic, Topeka, Kansas, 66606, United States; Recruiting

Anita S. Leonard, RN, BSN 785-354-0540

Wichita CCOP, Wichita, Kansas, 67214-3882, United States; Recruiting

Marge J. Good, RN, BSN 316-268-5696

University of Kansas Medical Center, Kansas City, Kansas, 66160, United States; Recruiting

Scott Stanley 913-588-3124 sstanley@kumc.edu

United States, Kentucky
Louisville VA Medical Center, Louisville, Kentucky, 40206-1499, United States; Recruiting

Patricia A Quiggins, PhD 502-895-3401 Ext. 5131 paquig01@gwise.louisville.edu

Our Lady of Bellefonte Hospital Inc., Ashland, Kentucky, 41101, United States; Recruiting

Barb Payne, RN, DNC 606-833-3253 bpayne@olbh.com

University of Kentucky Medical Center, Lexington, Kentucky, 40536-0093, United States; Recruiting

PREADVISE Coordination Center 866-846-1412 preadvise@lsv.uky.edu

United States, Maryland
Anne Arundel Medical Center, Annapolis, Maryland, 21401-2777, United States; Recruiting

Elizabeth F Egan, RN 443-481-5811 eegan@aahs.org

United States, Massachusetts
Berkshire Hematology Oncology/Bershire Medical Center, Pittsfield, Massachusetts, 01201, United States; Recruiting

Gloria F. Gero, CCRA 413-496-8205

United States, Michigan
Bixby Oncology Center, Adrian, Michigan, 49221, United States; Recruiting

Michael Uscio 419-843-6147

Henry Ford Hospital, Detroit, Michigan, 48202, United States; Recruiting

Teresa Kay, CRA 313-916-3721

Grand Rapids Clinical Oncology Program CCOP, Grand Rapids, Michigan, 49503-2560, United States; Recruiting

Connie M. Szczepanek, RN, BSN 616-391-1230

Monroe Clinic, Monroe, Michigan, 48162, United States; Recruiting

Debbie Osemtoski, RN, BSN 734-242-8585

St. Joseph Mercy Oakland, Pontiac, Michigan, 48341, United States; Recruiting

Liz A. Bowie, RN, BSN 248-858-6215

Munson Medical Center, Traverse City, Michigan, 49684-2386, United States; Recruiting

Pamela J. Bergman, BSN, RN 231-935-6300

United States, Minnesota
Duluth CCOP, Duluth, Minnesota, 55805, United States; Recruiting

Nancy E. Loughran, RN 218-786-8278

United States, Mississippi
Delta Health Center, Mound Bayou, Mississippi, 38762, United States; Not yet recruiting

United States, Missouri
St. John’s Regional Medical Center, Joplin, Missouri, 64804, United States; Recruiting

Rita Glaze, RN 417-625-2949

Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting

Dean A. Matthews, MBA, JD 417-269-4880

St. John’s Health System, Springfield, Missouri, 65804, United States; Recruiting

Gail Black, RN 417-269-6513

United States, Montana
Montana Cancer Consortium CCOP, Billings, Montana, 59101, United States; Recruiting

Shirley A Hall, CCRA 406-259-2245 mcc@mcn.net

Benefis Health Care, Great Falls, Montana, 59405, United States; Recruiting

Laura K. Hodges 406-727-4584

United States, Nebraska
Cancer Resource Center, Lincoln, Nebraska, 68510-4844, United States; Recruiting

Kay L Hoff, RN, BSN 402-483-2827 khoff@lmef.org

Missouri Valley Cancer Cons CCOP/Creighton University, Omaha, Nebraska, 68131, United States; Recruiting

Penny Jo Anzures, CRA 402-280-5274 panzures@creighton.edu

Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, 68124, United States; Recruiting

Catherine T. Basham, RN 402-572-3223

Alegent Health Immanuel Medical Center, Omaha, Nebraska, 68122, United States; Recruiting

Catherine T. Basham, RN 402-572-3223

Good Samaritan Health Systems – Cancer Center, Kearney, Nebraska, 68847, United States; Recruiting

Connie S. Wittman, RN, MN 308-865-7564

United States, Nevada
Washoe Medical Center, Reno, Nevada, 89520, United States; Recruiting

Jeannine Moore, RN, MSN 775-982-5050

United States, New Jersey
Riverview Medical Center, Red Bank, New Jersey, 07701, United States; Recruiting

Roxanne Valasa, RN 732-530-2382

VAMC New Jersey Health Care System, East Orange, New Jersey, 07018-1095, United States; Recruiting

Karen Long, RN, APN 973-676-1000

Warren Hospital, Phillipsburg, New Jersey, 08865, United States; Recruiting

Bonnie L. Perrucci, RN, MSN 908-859-6700

United States, New York
Bassett Research Institute, Cooperstown, New York, 13326-1394, United States; Recruiting

Anne-Marie Whitaker, BSN 607-547-3399 anne-marie.whitaker@bassett.org

Glens Falls Hospital, Glens Falls, New York, 12801, United States; Recruiting

Barbara A. Sponzo, CCRA 518-926-6700

Stratton Veterans Affairs Medical Center, Albany, New York, 12208, United States; Recruiting

Lori Megherian 518-626-6448 lori.megherian@med.va.gov

United States, Ohio
Good Samaritan Hospital, Cincinnati, Ohio, 45220-2489, United States; Recruiting

Elyce P. Turba, RN 513-872-2293

Columbus CCOP, Columbus, Ohio, 43206, United States; Recruiting

Deborah A. Halk, RN 614-443-5243

Fremont Memorial Hospital, Fremont, Ohio, 43420, United States; Not yet recruiting
NW Ohio Oncology Center/St. Luke’s Hospital, Maumee, Ohio, 43537, United States; Recruiting

Brenda Buczek, RN 419-891-5600

St. Charles Hospital, Oregon, Ohio, 43616, United States; Recruiting

Karen Schultz 419-696-7465

Flower Hospital, Sylvania, Ohio, 43560-2197, United States; Recruiting

Denise Allen, RN 419-472-0798

St. Vincent Medical Center, Toledo, Ohio, 43608, United States; Recruiting

Jane Ringlein, RN, MSN 419-251-4239

Toledo CCOP, Toledo, Ohio, 43623, United States; Recruiting

Diana J. Frie, PhD 419-843-6147

Toledo Clinic Inc., Toledo, Ohio, 43623, United States; Recruiting

Michael W. Uscio 419-843-6147

Toledo Hospital, Toledo, Ohio, 43606, United States; Recruiting

Maureen Williams, RN 419-479-8885

United States, Oklahoma
Muskogee Regional Medical Center, Muskogee, Oklahoma, 74401-5075, United States; Recruiting

Rebecca A Maycher, RN, BSN 918-684-2387 maycher@muskogeehealth.com

United States, Pennsylvania
Lehigh Valley Hospital, Allentown, Pennsylvania, 18103, United States; Recruiting

Deborah R Kane, RN 610-402-0581 deborah.kane@lvh.com

Abington Memorial Hospital, Abington, Pennsylvania, 19001-3788, United States; Recruiting

Sondra B. Mabry, RN 215-481-2402

St. Luke’s Hospital and Health Network, Bethlehem, Pennsylvania, 18015, United States; Recruiting

Kelly A. Filchner, MSN, RN 610-954-3582

Doylestown Hospital, Doylestown, Pennsylvania, 18901, United States; Recruiting

Karen E. Quinlan, RN, BSN 215-345-2866

York Cancer Center/Wellspan Health, York, Pennsylvania, 17403-5049, United States; Not yet recruiting
United States, South Dakota
Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57105, United States; Recruiting

Judy Norman, RN 605-331-3257 cincod@cpc-clinics.com

United States, Tennessee
Methodist Regional Cancer Center, Oak Ridge, Tennessee, 37830, United States; Recruiting

Brenda S Morris, RN, OCN 865-481-1664 bmorris@covhlth.com

Thompson Cancer Survival Center, Knoxville, Tennessee, 37916, United States; Recruiting

Crystal M. Dugger, RN, BSN 865-541-2421

Baptist Memorial Hospital – Memphis, Memphis, Tennessee, 38120, United States; Recruiting

Pat Gish, RN 901-226-0033

Meharry Medical College, Nashville, Tennessee, 37208-3599, United States; Not yet recruiting
United States, Texas
Scott & White CCOP, Temple, Texas, 76508, United States; Recruiting

Laresa A Trusty 254-724-8384 ltrusty@swmail.sw.org

Methodist Hospitals of Dallas, Dallas, Texas, 75203, United States; Recruiting

Mary Padilla, LVN 214-947-3621 marypadilla@mhd.com

United States, Washington
Northwest Hospital, Seattle, Washington, 98133, United States; Recruiting

Jennifer Armstrong 206-368-6599

Cascadia Clinical Trials at St. Joseph Hospital, Bellingham, Washington, 98225-1898, United States; Recruiting

Lorina Hall, RN, MSN 360-738-6756

Swedish Medical Center, Seattle, Washington, 98104, United States; Recruiting

Jackie Dahlgren 206-215-3245

Virginia Mason CCOP, Seattle, Washington, 98101, United States; Recruiting

Beth Edelheit 206-341-0446 beth.edelheit@vmmc.org

United States, Wisconsin
Marshfield Clinic, Marshfield, Wisconsin, 54449-5703, United States; Recruiting

Debbie Schillinger, CCRP 715-387-9521 schillid@mmrfmfldclin.edu

Sinai Samaritan Medical Center, Milwaukee, Wisconsin, 53233, United States; Recruiting

Nancy Briggs, RN 414-219-7370 nancy_briggs@aurora.org

Canada, Ontario
Ottawa General Hospital, Ottawa, Ontario, K1H 8L6, Canada; Recruiting

Sylvia Schaus, PA 613-737-8659 sschaus@ottawahospital.on.ca

Puerto Rico
Altamira Family Medicine, San Juan, 00920, Puerto Rico; Recruiting

Lucy Cubano 787-792-9026 lcubano@prtc.net

Centro Clinico San Patricio, San Juan, 00921, Puerto Rico; Recruiting

Judith Sanchez 787-792-3203

Miguel Sosa Padilla, MD/San Juan City Hospital, San Juan, 00926, Puerto Rico; Recruiting

Irma Sotomayor-Gonzalez 787-764-8281

San Juan City Hospital – PR, Hematology Oncology Office, San Juan, 00936-8344, Puerto Rico; Recruiting

Doris Cuadrado 787-763-1296

San Juan Dr. I. Gonzalez Martinez/Centro Medico, San Juan, 00919-1811, Puerto Rico; Recruiting

Janice Diaz 787-641-7582

VAMC San Juan, San Juan, 00927, Puerto Rico; Recruiting

Janice Diaz 787-641-7582
Study chairs or principal investigators
William Markesbery, MD, Principal Investigator, Sanders-Brown Center on Aging
Frederick Schmitt, PhD, Principal Investigator, Sanders-Brown Center on Aging
Richard Kryscio, PhD, Principal Investigator, Sanders-Brown Center on Aging

More Information

SELECT trial information

Clinicaltrials.gov SELECT trial record

PREADVISE web site

Southwest Oncology Group

Publications

Lovell MA, Ehmann WD, Butler SM, Markesbery WR. Elevated thiobarbituric acid-reactive substances and antioxidant enzyme activity in the brain in Alzheimer’s disease. Neurology. 1995 Aug;45(8):1594-601.

Sano M, Ernesto C, Thomas RG, Klauber MR, Schafer K, Grundman M, Woodbury P, Growdon J, Cotman CW, Pfeiffer E, Schneider LS, Thal LJ. A controlled trial of selegiline, alpha-tocopherol, or both as treatment for Alzheimer’s disease. The Alzheimer’s Disease Cooperative Study. N Engl J Med. 1997 Apr 24;336(17):1216-22.

Markesbery WR, Carney JM. Oxidative alterations in Alzheimer’s disease. Brain Pathol. 1999 Jan;9(1):133-46. Review.

Study ID Numbers: IA0033
Last Updated: March 2, 2007
Record first received: June 25, 2002
ClinicalTrials.gov Identifier:
NCT00040378
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on May 23, 2007

 


Bathing Persons With Alzheimer’s Disease aT Home (The BATH Study)

This study is currently recruiting patients.
Verified by National Institute of Nursing Research (NINR) July 2003

Sponsored by: National Institute of Nursing Research (NINR)
Information provided by: National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier: NCT00062569

Purpose

This study will evaluate the effectiveness of a 3-week reminiscence intervention applied during bathing persons with Alzheimer’s disease (AD) in decreasing resistiveness to care (RTC), relieving patient discomfort, and improving spouse caregiver appraisals of burden, capabilities and confidence while bathing the patient. Reminiscence provides opportunities for the patient to feel good and recall pleasant memories, easily done by caregivers in a home setting. Home visits and telephone calls from trained nurses provide coaching and practice for caregivers for the preliminary phase of this study. Each couple will be enrolled in the study for approximately 9 weeks. The study will recruit 100 patient/spouse caregiver couples randomly divided into one of two groups: reminiscence with coaching, or bathing support (control). Bathing support will be provided to participants in both conditions including: individualized assessment; education regarding bathing techniques for people with dementia; and individualized problem solving. In addition to the bathing support intervention, participants in the experimental group will receive a pleasant memories interview and reminiscence script with coaching for implementation. Caregivers will keep a journal of their experiences in bathing the care recipient.
Condition Intervention
Alzheimer Disease
Behavior: Caregiver reminiscence with coaching

MedlinePlus related topics: Alzheimer’s Caregivers; Alzheimer’s Disease
Genetics Home Reference related topics: Alzheimer disease

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Reminiscence During Bathing Persons With Alzheimer’s Disease at Home

Further study details as provided by National Institute of Nursing Research (NINR):
Total Enrollment: 100

Study start: September 2002; Expected completion: June 2005

Bath time is often distressing to persons with Alzheimer’s disease (AD), leading to behavioral symptoms of resistiveness to care. Encountering these behaviors is distressing for caregivers, as well. Most studies of intervention for behavioral symptoms of AD have been done in nursing homes, but most care takes place in the home. The overall goal of this research is to improve the at-home bathing experience of both patients with AD and their spouse caregivers. This study builds on preliminary studies that: 1) developed observational measures of patient behaviors, and 2) developed and pilot tested the reminiscence during bathing intervention.

This randomized clinical trial will evaluate the effectiveness of a 3-week reminiscence intervention, applied during bathing persons with AD, in decreasing resistiveness to care (RTC), relieving patient discomfort, and improving spouse caregiver appraisals of burden, self-efficacy with bathing, and satisfaction. Reminiscence provides an intervention that draws on preserved individuality and memories, easily implemented by caregivers in a home setting. Home visits and telephone calls provide coaching and practice for caregivers in implementation. The sample includes 100 patient/spouse caregiver couples, randomized into one of two groups: reminiscence with coaching or bathing support (control).

Bathing support will be provided to participants in both conditions including: individualized assessment; education regarding bathing techniques for people with dementia; and individualized problem solving. In addition to the bathing support intervention, participants in the experimental group will receive a pleasant memories interview and reminiscence script with coaching for implementation. Using repeated measures design, observations will be made at baseline, post-intervention (5 weeks), and follow-up (8 weeks).

In the coaching/practicing/support phase of the study, caregivers will receive 1-hour home visits by a Nurse Interventionist (NI) for two weeks with caregiver practice and telephone support in between the in-home coaching/support visits. During the home visits, the NI will: (a) review the written reminiscence script and “crib sheet” with the spouse and role-model its use, (b) discuss instructions for delivering the reminiscence intervention to the patient immediately prior to and during the bath/shower, (c) teach the spouse to record patient behavior and intervention intensity using visual analog scales, and (d) review general approaches to bathing including a calm, unhurried approach, smiling, eye contact, brief description of what to expect, simple directions with time for the patient to respond, encourage patient participation, try not to respond to negative behaviors, praise for positive behaviors. Spouse caregivers will be encouraged to practice using the reminiscence intervention with every bath/shower for a 2-week period and to record the frequency of program implementation throughout the week on the data sheets.

Eligibility

Ages Eligible for Study: 60 Years and above, Genders Eligible for Study: Both
Criteria

Inclusion:

  • Have a diagnosis of probable Alzheimer’s disease or a related disorder according to standard criteria.
  • Have functional dependence in bathing;
  • Demonstrate resistiveness to care during bathing;
  • Live in the community in a home setting (house, apartment, condominium);
  • Have a primary caregiver spouse or partner who lives with the care recipient and agrees to be in the study; and
  • Have no anticipated admission for long term care within 3 months.
  • Must be married couples or life partners living with Alzheimer’s disease or related disorder living within a 15-mile radius of Boston College.
  • Spouse or caregiver partner is the primary caregiver, including assistance with bathing.
  • Women and minorities are encouraged to participate.

Exclusion:

  • Severe concomitant medical conditions of patient or spouse.
  • Not fluent in English.
  • Couple resides in an institutional setting.
  • Couple anticipates a significant change of living situation within three months.
  • Couple does not meet the above inclusion criteria.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00062569

Scott Trudeau, MA, OTR/L 1-866-576-4484 trudeasc@bc.edu
United States, Massachusetts
Boston College, William F. Connell School of Nursing, Chestnut Hill, Massachusetts, 02467-3812, United States; Recruiting

Scott Trudeau, MA, OTR/L 866-576-4484 trudeasc@bc.edu
Ellen K. Mahoney, DNS, RN, Principal Investigator
Study chairs or principal investigators
Ellen K. Mahoney, DNS, RN, Principal Investigator, Boston College, William F. Connell School of Nursing

More Information

Publications

Mahoney EK, Hurley AC, Volicer L, Bell M, Gianotis P, Hartshorn M, Lane P, Lesperance R, MacDonald S, Novakoff L, Rheaume Y, Timms R, Warden V. Development and testing of the Resistiveness to Care Scale. Res Nurs Health. 1999 Feb;22(1):27-38.

Moss SE, Polignano E, White CL, Minichiello MD, Sunderland T. Reminiscence group activities and discourse interaction in Alzheimer’s disease. J Gerontol Nurs. 2002 Aug;28(8):36-44.

Mahoney E, Volicer L, Hurley A. (2000). Managing Challenging Behaviors in Persons with Dementia. Baltimore, MD: Health Professions Press.

Study ID Numbers: IA0044; RO1 NR07893-01A1
Last Updated: June 23, 2005
Record first received: June 9, 2003
ClinicalTrials.gov Identifier:
NCT00062569
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on May 23, 2007

 


PET Changes in Alzheimer’s Disease (AD)

This study is currently recruiting patients.
Verified by National Institute on Aging (NIA) August 2006

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00094913

Purpose

The purpose of this study is to identify the earliest predictors of memory and brain deterioration in pre-clinical Alzheimer’s disease using positron emission tomography (PET) to monitor brain glucose metabolism.
Condition
Alzheimer Disease

MedlinePlus related topics: Alzheimer’s Caregivers; Alzheimer’s Disease
Genetics Home Reference related topics: Alzheimer disease

Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study

Official Title: Clinical Correlates of Longitudinal PET Changes in Alzheimer’s Disease (AD)

Further study details as provided by National Institute on Aging (NIA):
Total Enrollment: 105

Study start: May 2004; Expected completion: April 2005

Previous studies indicate that the brain’s glucose metabolism rate potentially may be an early indicator of damage to particular regions of the brain caused by AD, including loss of neurons, synapses, and other changes. Many of these changes are reported among patients with mild cognitive impairment (MCI), a group known to be at increased risk for AD.

The overall goal of this study is to use FDG-PET (2-[(18)F]fluoro-2-deoxy-d-glucose/positron-emission tomography) to determine whether metabolic abnormalities in the hippocampus predict memory and brain deterioration in middle age, and to identify the brain glucose metabolism predictors of future MCI.

Participants in the study will be grouped into 3 main groups of 35 each, including young individuals (20-40 years of age), 41-90 year-old normal, and MCI individuals with or without risk for memory decline. Participants will undergo baseline and 36-month follow-up exams to include comprehensive medical, neurologic, and psychiatric evalutions; lumbar puncture; a resting FDG-PET; an MRI scan; and a neuropsychological battery. A brief medical exam, full neuropsychological battery, and MRI scan will be administered at 18 months. Two subgroups (groups 4 and 5) of 15 each will be created from groups 1 and 2 at 18 months to participate in the evaluation of memory performance under acute hyperglycemia and saline challenges and effects on hippocampal formation and glucose metabolism.

Eligibility

Ages Eligible for Study: 20 Years – 90 Years, Genders Eligible for Study: Both Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Males and females with a minimum high school education and between the ages of 50 and 90 will be selected for Groups 1 and 2. For Group 3, normal subjects between the ages of 20 and 49 years of age will be selected. The Groups 1 and 2 will be balanced for age, and all three groups balanced for gender and ApoE genotype.
  • Discontinuance of all psychotropic and/or cognitively active medication at least four weeks prior to evaluation.

Exclusion Criteria:

  • Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurological disorder.
  • Significant history of alcoholism or drug abuse.
  • Any history of psychiatric illness (e.g., schizophrenia, mania or depression).
  • Any focal signs or significant neuropathology.
  • A score of 4 or greater on the Modified Hachinski Ischemia Scale, indicative of cerebrovascular disease.
  • A total score of 16 or more on the Hamilton Depression Scale to exclude possible cases of primary depression.
  • Evidence of clinically relevant hypertensive, cardiac, pulmonary, vascular, metabolic or hematologic conditions. Specific exclusion will be made for individuals with fasting glucose levels >110 mg/dl.
  • Physical impairment of such severity as to adversely affect the validity of psychological testing.
  • Hostility or refusal to cooperate.
  • Any prosthetic devices (e.g., pacemaker or surgical clips) that could be affected by the magnetic field employed during MRI imaging.
  • Evidence of cognitive or memory impairment reaching early AD levels at the initial evaluation. At baseline, delayed paragraph recall z-scores > 2 below the reference group.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00094913

Kenneth E. Rich 212-263-7563 kenneth.rich@med.nyu.edu
United States, New York
Center for Brain Health, Silberstein Institute, New York University, New York City, New York, 10016, United States; Recruiting

Kenneth E. Rich 212-263-7563 kenneth.rich@med.nyu.edu
Mony J. de Leon, Ed.D., Principal Investigator
Study chairs or principal investigators
Mony J. de Leon, Ed.D., Principal Investigator, Center for Brain Health, Silberstein Institute

More Information

Silberstein Institute for Aging and Dementia, New York University School of Medicine

Publications

de Leon MJ, Convit A, Wolf OT, Tarshish CY, DeSanti S, Rusinek H, Tsui W, Kandil E, Scherer AJ, Roche A, Imossi A, Thorn E, Bobinski M, Caraos C, Lesbre P, Schlyer D, Poirier J, Reisberg B, Fowler J. Prediction of cognitive decline in normal elderly subjects with 2-[(18)F]fluoro-2-deoxy-D-glucose/poitron-emission tomography (FDG/PET). Proc Natl Acad Sci U S A. 2001 Sep 11;98(19):10966-71. Epub 2001 Aug 28.

Bobinski M, de Leon MJ, Convit A, De Santi S, Wegiel J, Tarshish CY, Saint Louis LA, Wisniewski HM. MRI of entorhinal cortex in mild Alzheimer’s disease. Lancet. 1999 Jan 2;353(9146):38-40. No abstract available.

De Santi S, de Leon MJ, Rusinek H, Convit A, Tarshish CY, Roche A, Tsui WH, Kandil E, Boppana M, Daisley K, Wang GJ, Schlyer D, Fowler J. Hippocampal formation glucose metabolism and volume losses in MCI and AD. Neurobiol Aging. 2001 Jul-Aug;22(4):529-39.

Study ID Numbers: IA0055; R01 AG13616
Last Updated: August 15, 2006
Record first received: October 28, 2004
ClinicalTrials.gov Identifier:
NCT00094913
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on May 23, 2007

 


Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer’s Disease

This study is currently recruiting patients.
Verified by National Institute of Mental Health (NIMH) April 2007

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00183378

Purpose

This study will compare four different behavioral treatment programs to determine which is most effective in reducing night-time disturbances in individuals with Alzheimer’s disease (AD).
Condition Intervention
Alzheimer Disease
Sleep Initiation and Maintenance Disorders
Behavior: Walking Program
Behavior: Light Exposure Program
Behavior: Combined Walking and Light Exposure Program (Nite-ad)
Behavior: Sleep Disturbance Education

MedlinePlus related topics: Alzheimer’s Caregivers; Alzheimer’s Disease; Sleep Disorders
Genetics Home Reference related topics: Alzheimer disease

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Behavioral Treatment of Nocturnal Disturbances in Alzheimer’s Disease

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

  • Actigraph measures
  • Caregiver reports of patient behavioral disturbances at night

Secondary Outcome Measures:

  • Caregiver sleep
  • Patient daytime sleepiness, behavioral problems, and residential status

Total Enrollment: 136

Study start: September 2005

Nocturnal disturbances, such as getting out of bed repeatedly, having hallucinations, talking or singing in bed, and waking up confused are common among patients with AD. Such nocturnal disturbances are associated with increased physical and psychological morbidity in both AD patients and their caregivers and are a major risk factor for patient institutionalization. Nonpharmacologic treatments for these disturbances are needed. This study will assign AD patients to one of four different treatments to determine which is most effective in reducing nocturnal disturbances.

This study will last 6 months. Participants will be randomly assigned to a walking program, a light exposure program, a “Nite-ad” program, combining the walking and light exposure programs, or routine AD care with nocturnal disturbance education. Walking program participants will have three 1-hour visits with a therapist over an 8-week period. The therapist and the participant will set an initial daily walking goal and develop a plan for gradually increasing the participants’ walking to 30 minutes/day, to be increased at a participant-selected pace. Pedometers will be given to participants to monitor daily activity. The therapist will also discuss exercise safety and will review ways to prevent muscle soreness. Light program participants will also have three 1-hour visits with a therapist over 8 weeks. The therapist will develop a daily, caregiver-supervised light exposure plan requiring participants to sit in front of a light box for 1 hour every day. Nite-ad program participants will have six 1-hour visits with a therapist over 8 weeks; their visits will include both the walking and the light exposure program visits. Participants assigned to receive education about night disturbances associated with Alzheimer’s disease will not receive any treatment in the study, but will continue their usual treatment outside of the study.

Participants will be assessed at study entry and at Months 2 and 6. The sleep patterns of both the patients and the caregivers will be measured. Caregiver reports of patients’ night-time behavioral disturbances and readings from an actigraph, a small electronic device worn by participants that records and reports their levels of activity at night, will be used to assess participants. A follow-up visit will occur 6 months after study completion; at the follow-up visit, participants and their caregivers will be interviewed about the participants’ nocturnal disturbances.

Eligibility

Ages Eligible for Study: 55 Years and above, Genders Eligible for Study: Both
Criteria

Inclusion Criteria for AD Patients:

  • Diagnosis of AD
  • Have at least two sleep disturbances each week
  • Reside in a residential home with a family member caregiver
  • Able to walk without assistance

Exclusion Criteria for AD Patients:

  • Pre-existing diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder
  • Blindness
  • Current use of photosensitizing medication

Inclusion Criteria for Family Caregiver:

  • Currently caring for a family member with Alzheimer’s disease

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00183378

Amy Moore, MS 206-616-5550 amoore@u.washington.edu
United States, Washington
University of Washington, Seattle, Washington, 98195, United States; Recruiting

Amy Moore, MS 206-616-5550 amoore@u.washington.edu
Susan M. McCurry, PhD, Principal Investigator
Study chairs or principal investigators
Susan M. McCurry, PhD, Principal Investigator, University of Washington

More Information

Publications

McCurry SM, Gibbons LE, Logsdon RG, Vitiello MV, Teri L. Nighttime insomnia treatment and education for Alzheimer’s disease: a randomized, controlled trial. J Am Geriatr Soc. 2005 May;53(5):793-802.

McCurry SM, Gibbons LE, Logsdon RG, Vitiello M, Teri L. Training caregivers to change the sleep hygiene practices of patients with dementia: the NITE-AD project. J Am Geriatr Soc. 2003 Oct;51(10):1455-60.

McCurry SM, Logsdon RG, Teri L, Gibbons LE, Kukull WA, Bowen JD, McCormick WC, Larson EB. Characteristics of sleep disturbance in community-dwelling Alzheimer’s disease patients. J Geriatr Psychiatry Neurol. 1999 Summer;12(2):53-9.

McCurry SM, Reynolds CF, Ancoli-Israel S, Teri L, Vitiello MV. Treatment of sleep disturbance in Alzheimer’s disease. Sleep Med Rev. 2000 Dec;4(6):603-628.

Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22.

Study ID Numbers: R01 MH72736; DATR A4-GPS
Last Updated: April 4, 2007
Record first received: September 13, 2005
ClinicalTrials.gov Identifier:
NCT00183378
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on May 23, 2007