Prevention and Risk Factor

Prevention and risk factor trials recruiting in the United States

(Data are as of July 24, 2009. Only select studies and criteria are given; see ClinicalTrials.gov for complete information.)

Alzheimer's Disease Genetics Study
Sponsored by: National Institute on Aging (NIA)
ClinicalTrials.gov #: NCT00064870
Study Phase: Not applicable

Study Location(s) and Contact Information
Multiple study locations around the United States
NCRAD study coordinator, 1.800.526.2839
Spanish-speaking Contact, 1.800.243.5828

Study Purpose
This study seeks to identify genes that are responsible for increasing a person’s risk of acquiring Alzheimer’s disease. The main research team is based at the National Cell Repository for Alzheimer's Disease (NCRAD) at Indiana University. This team will collect and analyze genetic material from families in which multiple members have been diagnosed with Alzheimer’s after age 60.

You may qualify if you

have two living family members diagnosed with Alzheimer’s disease
have at least one other relative, with or without Alzheimer’s, who is willing to participate

You may not qualify if you

have a mutation in a gene related to early-onset Alzheimer’s disease
have a member of the family who was included in the National Institute of Mental Health’s (NIMH’s) Alzheimer’s disease sibling pair collection

Metformin in Amnestic Mild Cognitive Impairment (MCI)
Sponsored by: Columbia University;
Institute for the Study of Aging;
National Institute on Aging (NIA)
ClinicalTrials.gov #: NCT00620191
Study Phase: Phase II

Study Location(s) and Contact Information
Columbia University Medical Center
New York, New York 10032
Jose A Luchsinger, M.D., 1.212.305.4730
jal94@columbia.edu

Study Purpose
People with type 2 diabetes and hyperinsulinemia can no longer use the hormone insulin efficiently to convert sugar into energy. Such disorders are also potential risk factors for acquiring Alzheimer’s disease. This study proposes to use metformin, a common diabetes drug, to regulate insulin levels in overweight people with a) type 2 diabetes or hyperinsulinemia and b) amnestic mild cognitive impairment, a condition that often precedes Alzheimer’s. The team hopes to learn whether such an intervention might help prevent such people from acquiring Alzheimer’s over time.

You may qualify if you

are 55 to 90 years old
have a diagnosis of amnestic mild cognitive impairment
have a body mass index of 25 kg/m2 or greater
have vision and hearing that is adequate for compliance with testing procedures

You may not qualify if you

have a history of diabetes
have uncontrolled high blood pressure
have had cancer within the last five years—with the exceptions of squamous or basal cell carcinoma of the skin
have liver disease, congestive heart failure, or an alcohol addiction

Dominantly Inherited Alzheimer Network (DIAN)
Sponsored by: National Institute on Aging (NIA)
ClinicalTrials.gov #: NCT00869817
Study Phase: Not applicable

Study Location(s) and Contact Information
10 study locations in the United States, Australia, and the United Kingdom
Angie Berry, R.N., M.S.N., C.C.R.A., 1.314.286.2442
berrya@abraxas.wustl.edu

Study Purpose
This study plans to analyze the genetic mutations that occur in people who develop a rare, inherited form of Alzheimer's disease.

You may qualify if you

are at least 18 years old
are a child of an individual with the inherited form of Alzheimer’s disease that is the focus of this study
are cognitively normal or, if you have dementia, do not require nursing home care
have someone who is not a child of the affected parent and who can serve as an informant for the study

You may not qualify if you

have a medical or psychiatric illness that would prevent you from completing the study

A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease
Sponsored by: Bristol-Myers Squibb
ClinicalTrials.gov #: NCT00890890
Study Phase: Phase II

Study Location(s) and Contact Information
75 study locations in the United States, Canada, and Europe
Bristol-Myers Squibb,
Clinical.Trials@bms.com
U.S. Government website,
http://clinicaltrials.gov/ct2/show/NCT00890890

Study Purpose This study will determine the effectiveness of the drug BMS-708163 in people with very early Alzheimer's disease. BMS-708163 is designed to hinder the production of beta-amyloid, a protein fragment that is a key suspect in Alzheimer’s.

You may qualify if you

meet the criteria for prodromal Alzheimer’s disease
have noticed your own memory loss
have a reliable study partner

You may not qualify if you

are a woman of childbearing potential
have a non-Alzheimer form of dementia
have a history of stroke
have a compromised immune system
have active peptic ulcers, chronic inflammatory bowel disease, chronic diarrhea, or past gastrointestinal surgery that would impact your ability to absorb the drugs in this study
have an unstable vitamin B-12 deficiency
have a history of alcohol or drug abuse within 12-months of study entry
have a significant drug allergy
reside in a nursing home or skilled nursing facility
have taken any other experimental therapy within 30 days of study entry

SMART: Somatotrophics, Memory, and Aging Research Trial
Sponsored by: National Institute on Aging (NIA)
ClinicalTrials.gov #: NCT00257712
Study Phase: Phase II

Study Location(s) and Contact Information
University of Washington
Seattle, Washington 98195
Suzanne V. Barsness, R.N., M.S.N., C.C.R.C., 1.206.543.3897
barsness@u.washington.edu

Study Purpose The SMART study aims to learn whether the body's own production of growth hormone will improve cognitive function and help prevent Alzheimer’s disease. Human growth hormone assists in the production of brain cells. This study will assess healthy older people and those with mild cognitive impairment, a condition that often precedes Alzheimer’s.

You may qualify if you

are either cognitively normal or have mild cognitive impairment
are 55 to 90 years old
have independent daily living abilities
are living at home with a reliable spouse, significant other or caregiver

You may not qualify if you

have uncontrolled hypertension, diabetes or heart disease
have a significant brain disorder that might affect cognition, including Alzheimer's disease, stroke, Parkinson's disease, multiple sclerosis or severe head injury
have a family or personal history of cancer
have pituitary disease
have a history of carpal tunnel syndrome
have schizophrenia or another psychiatric illness
use medications that will negatively interact with growth hormone treatment
currently take an anti-psychotic, anti-depressant, anti-convulsant, anti-coagulant or sedative drug
use testosterone or cognition-enhancing medication
exceed 150 percent of your ideal body weight
have a history of tobacco use, excessive alcohol intake or excessive caffeine intake

The Mental Activity and eXercise Trial for Seniors (MAX)
Sponsored by: University of California, San Francisco;
Alzheimer's Association; National Institutes of Health (NIH);
Posit Science Corporation; YMCA of San Francisco
ClinicalTrials.gov #: NCT00522899
Study Phase: Not applicable

Study Location(s) and Contact Information
Two study locations in San Francisco
Deborah E Barnes, Ph.D., M.P.H., 1.415.221.4810, ext 4221
Deborah.Barnes@ucsf.edu
Jacy Leonardo, M.A., 415.221.4810, ext 4618
jacy.leonardo@ucsf.edu

Study Purpose
This study will assess whether engaging in mental activity or exercise, either alone or in combination, can improve cognition in non-demented, inactive older adults who report a recent decline in memory or thinking. The researchers will also determine whether these interventions affect changes in the rate of cognitive decline or risk of dementia after the intervention period has ended.

You may qualify if you

are more than 64 years old
have reported a recent decline in memory or thinking
receive less than 60 minutes of exercise each week for the 3 months before study screening
acquire your physician’s approval for study participation

You may not qualify if you

have evidence of dementia
have a significant central nervous system disorder, such as Parkinson's disease, multiple sclerosis, or Lou Gehrig's disease
have schizophrenia or another major psychiatric disorder
have had a stroke or other major central nervous system event
have significant heart or lung disease
have severe hearing or visual impairment or learning disability
take a prescribed medication to enhance cognitive function
are unable to undertake basic activities of daily living, such as eating, dressing, or bathing
have a history of alcohol abuse or heavy drug use
are currently enrolled in another research study
have fibromyalgia or tremor severe enough to prevent you from using a computer mouse