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 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

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

Total Enrollment: 3000

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.

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.

Please refer to this study by ClinicalTrials.gov identifier NCT00064870

 

Jessica Leatherland, NCRAD 1-800-526-2839 This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
Valerie P. Parks, NCRAD 317-278-9546 This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

United States, Indiana
Participants are being recruited from all over the United States, Nationwide, Indiana, United States; Recruiting

Study chairs or principal investigators

Tatiana M. Foroud, PhD, Principal Investigator, National Cell Repository for Alzheimer's Disease (NCRAD), Indiana University

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

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.

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

Total Enrollment: 40

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.

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.

Please refer to this study by ClinicalTrials.gov identifier NCT00413621

 

Andrea Nelson, R.N. Not Listed This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

United States, Maryland
Johns Hopkins University, Baltimore, Maryland, 21205, United States; Recruiting

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

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.

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

Total Enrollment: 10400

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.

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.

Please refer to this study by ClinicalTrials.gov identifier NCT00040378

 

Cecil R. Runyons 1-859-257-1412 Ext. 235 This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

United States, Alabama
University of Alabama at Birmingham Preventive Medicine, Birmingham, Alabama, 35294-4410, United States; Recruiting
United States, Alaska
Providence Alaska Medical Center, Anchorage, Alaska, 99508, United States; Recruiting
Alaska Regional Hospital, Anchorage, Alaska, 99508, United States; Recruiting
United States, California
VA Medical Center, Loma Linda, California, 92354-3866, United States; Recruiting
Santa Rosa Memorial Hospital Regional CCOP, Santa Rosa, California, 95403, United States; Recruiting
Harbor UCLA Medical Cemter, Torrance, California, 90502-2064, United States; Recruiting
Lionel B. Katchem, Upland, California, 91786, United States; Recruiting
University of California, San Diego - Chula Vista, Chula Vista, California, 91910, United States; Recruiting
Glendale Memorial Hospital, Glendale, California, 91204, United States; Recruiting
University of California, San Diego, La Jolla, California, 92037-1709, United States; Recruiting
VAMC Long Beach, Long Beach, California, 90822, United States; Recruiting
Northridge Hospital Medical Center, Northridge, California, 91328, United States; Recruiting
United States, Colorado
Rocky Mountain CC/Poudre Valley Hospital, Fort Collins, Colorado, 80524, United States; Recruiting
United States, District of Columbia
DC United MBCCOP, Washington, DC, District of Columbia, 20060-0001, United States; Recruiting
George Washington University Medical Center, Washington, DC, District of Columbia, 20037, United States; Recruiting
Sibley Memorial Hospital, Washington, DC, District of Columbia, 20016, United States; Recruiting
United States, Florida
Baptist Medical Center, Jacksonville, Florida, 32207-8560, United States; Recruiting
United States, Georgia
Kaiser Southeast Permanente Medical Group, Tucker, Georgia, 30084, United States; Recruiting
United States, Iowa
Bliss Cancer Center/McFarland Clinic/Mary Greely MC, Ames, Iowa, 50010, United States; Recruiting
Cedar Rapids CCOP, Cedar Rapids, Iowa, 52403, United States; Recruiting
Genesis Medical Center, Davenport, Iowa, 52804, United States; Not yet recruiting
Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
Siouxland Hematology-Oncology Associates, Sioux City, Iowa, 51101, United States; Recruiting
United States, Kansas
Stormont-Vail Health Care/Cotton O'Neil Clinic, Topeka, Kansas, 66606, United States; Recruiting
Wichita CCOP, Wichita, Kansas, 67214-3882, United States; Recruiting
University of Kansas Medical Center, Kansas City, Kansas, 66160, United States; Recruiting
United States, Kentucky
Louisville VA Medical Center, Louisville, Kentucky, 40206-1499, United States; Recruiting
Our Lady of Bellefonte Hospital Inc., Ashland, Kentucky, 41101, United States; Recruiting
University of Kentucky Medical Center, Lexington, Kentucky, 40536-0093, United States; Recruiting
United States, Maryland
Anne Arundel Medical Center, Annapolis, Maryland, 21401-2777, United States; Recruiting
United States, Massachusetts
Berkshire Hematology Oncology/Bershire Medical Center, Pittsfield, Massachusetts, 01201, United States; Recruiting
United States, Michigan
Bixby Oncology Center, Adrian, Michigan, 49221, United States; Recruiting
Henry Ford Hospital, Detroit, Michigan, 48202, United States; Recruiting
Grand Rapids Clinical Oncology Program CCOP, Grand Rapids, Michigan, 49503-2560, United States; Recruiting
Monroe Clinic, Monroe, Michigan, 48162, United States; Recruiting
St. Joseph Mercy Oakland, Pontiac, Michigan, 48341, United States; Recruiting
Munson Medical Center, Traverse City, Michigan, 49684-2386, United States; Recruiting
United States, Minnesota
Duluth CCOP, Duluth, Minnesota, 55805, United States; Recruiting
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
Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
St. John's Health System, Springfield, Missouri, 65804, United States; Recruiting
United States, Montana
Montana Cancer Consortium CCOP, Billings, Montana, 59101, United States; Recruiting
Benefis Health Care, Great Falls, Montana, 59405, United States; Recruiting
United States, Nebraska
Cancer Resource Center, Lincoln, Nebraska, 68510-4844, United States; Recruiting
Missouri Valley Cancer Cons CCOP/Creighton University, Omaha, Nebraska, 68131, United States; Recruiting
Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, 68124, United States; Recruiting
Alegent Health Immanuel Medical Center, Omaha, Nebraska, 68122, United States; Recruiting
Good Samaritan Health Systems - Cancer Center, Kearney, Nebraska, 68847, United States; Recruiting
United States, Nevada
Washoe Medical Center, Reno, Nevada, 89520, United States; Recruiting
United States, New Jersey
Riverview Medical Center, Red Bank, New Jersey, 07701, United States; Recruiting
VAMC New Jersey Health Care System, East Orange, New Jersey, 07018-1095, United States; Recruiting
Warren Hospital, Phillipsburg, New Jersey, 08865, United States; Recruiting
United States, New York
Bassett Research Institute, Cooperstown, New York, 13326-1394, United States; Recruiting
Glens Falls Hospital, Glens Falls, New York, 12801, United States; Recruiting
Stratton Veterans Affairs Medical Center, Albany, New York, 12208, United States; Recruiting
United States, Ohio
Good Samaritan Hospital, Cincinnati, Ohio, 45220-2489, United States; Recruiting
Columbus CCOP, Columbus, Ohio, 43206, United States; Recruiting
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
St. Charles Hospital, Oregon, Ohio, 43616, United States; Recruiting
Flower Hospital, Sylvania, Ohio, 43560-2197, United States; Recruiting
St. Vincent Medical Center, Toledo, Ohio, 43608, United States; Recruiting
Toledo CCOP, Toledo, Ohio, 43623, United States; Recruiting
Toledo Clinic Inc., Toledo, Ohio, 43623, United States; Recruiting
Toledo Hospital, Toledo, Ohio, 43606, United States; Recruiting
United States, Oklahoma
Muskogee Regional Medical Center, Muskogee, Oklahoma, 74401-5075, United States; Recruiting
United States, Pennsylvania
Lehigh Valley Hospital, Allentown, Pennsylvania, 18103, United States; Recruiting
Abington Memorial Hospital, Abington, Pennsylvania, 19001-3788, United States; Recruiting
St. Luke's Hospital and Health Network, Bethlehem, Pennsylvania, 18015, United States; Recruiting
Doylestown Hospital, Doylestown, Pennsylvania, 18901, United States; Recruiting
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
United States, Tennessee
Methodist Regional Cancer Center, Oak Ridge, Tennessee, 37830, United States; Recruiting
Thompson Cancer Survival Center, Knoxville, Tennessee, 37916, United States; Recruiting
Baptist Memorial Hospital - Memphis, Memphis, Tennessee, 38120, United States; Recruiting
Meharry Medical College, Nashville, Tennessee, 37208-3599, United States; Not yet recruiting
United States, Texas
Scott & White CCOP, Temple, Texas, 76508, United States; Recruiting
Methodist Hospitals of Dallas, Dallas, Texas, 75203, United States; Recruiting
United States, Washington
Northwest Hospital, Seattle, Washington, 98133, United States; Recruiting
Cascadia Clinical Trials at St. Joseph Hospital, Bellingham, Washington, 98225-1898, United States; Recruiting
Swedish Medical Center, Seattle, Washington, 98104, United States; Recruiting
Virginia Mason CCOP, Seattle, Washington, 98101, United States; Recruiting
United States, Wisconsin
Marshfield Clinic, Marshfield, Wisconsin, 54449-5703, United States; Recruiting
Sinai Samaritan Medical Center, Milwaukee, Wisconsin, 53233, United States; Recruiting
Canada, Ontario
Ottawa General Hospital, Ottawa, Ontario, K1H 8L6, Canada; Recruiting
Puerto Rico
Altamira Family Medicine, San Juan, 00920, Puerto Rico; Recruiting
Centro Clinico San Patricio, San Juan, 00921, Puerto Rico; Recruiting
Miguel Sosa Padilla, MD/San Juan City Hospital, San Juan, 00926, Puerto Rico; Recruiting
San Juan City Hospital - PR, Hematology Oncology Office, San Juan, 00936-8344, Puerto Rico; Recruiting
San Juan Dr. I. Gonzalez Martinez/Centro Medico, San Juan, 00919-1811, Puerto Rico; Recruiting
VAMC San Juan, San Juan, 00927, Puerto Rico; Recruiting

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

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

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.

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

Total Enrollment: 100

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.

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.

Please refer to this study by ClinicalTrials.gov identifier NCT00062569

 

Scott Trudeau, MA, OTR/L 1-866-576-4484 This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

United States, Massachusetts
Boston College, William F. Connell School of Nursing, Chestnut Hill, Massachusetts, 02467-3812, United States; Recruiting

Study chairs or principal investigators

Ellen K. Mahoney, DNS, RN, Principal Investigator, Boston College, William F. Connell School of Nursing

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

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.

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

Total Enrollment: 105

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.

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.

Please refer to this study by ClinicalTrials.gov identifier NCT00094913

 

Kenneth E. Rich 212-263-7563 This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

United States, New York
Center for Brain Health, Silberstein Institute, New York University, New York City, New York, 10016, United States; Recruiting

Study chairs or principal investigators

Mony J. de Leon, Ed.D., Principal Investigator, Center for Brain Health, Silberstein Institute

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

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).

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

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.

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

Please refer to this study by ClinicalTrials.gov identifier NCT00183378

 

Amy Moore, MS 206-616-5550 This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

United States, Washington
University of Washington, Seattle, Washington, 98195, United States; Recruiting

Study chairs or principal investigators

Susan M. McCurry, PhD, Principal Investigator, University of Washington

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