Biomarkers and Early Alzheimer's Disease
Status unconfirmed
Conditions studied: Alzheimer's Disease
In brief
The main goal of this project is to use imaging and biomarkers to identify cognitively normal elderly people who are at increased risk for developing mild cognitive impairment (MCI). MCI is the earliest clinically detectable evidence for brain changes due to Alzheimer's disease (AD). The second goal of this project is to describe the inter-relationships among anatomical biomarkers, cerebrospinal fluid biomarkers, and cognition measures in those elderly people who develop MCI.
Key facts
- Study ID
- NCT00094952
- Run by
- National Institute on Aging (NIA)
- People needed
- 80
- Starts
- 2003-04-01
- Expected to finish
- 2008-03-01
- Last updated by the study team
- 2009-09-18
Who can join
Age: 60 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Individuals of either sex, with a high school education, and between the ages of 60 and 80 years living in the New York City metropolitan area.
- Minimum of 12 years education.
- Participants will be classified as within normal limits on medical, psychiatric and neuropsychological examinations (performance that is better than -1.5 sd of the NYU norm based WMS-R delayed memory index).
- Participants will have a global deterioration scale (GDS)=1 or 2. Those enrolled in the High-Risk group will have a GDS=2 and have a score of >25 on the Memory Complaint Questionnaire (MCQ). In high risk memory loss cases, an informed family member or caregiver will be interviewed to confirm that the participant can perform specific tasks.
You may not qualify if…
- 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.
- History of psychiatric illness (e.g., schizophrenia, mania, Post-Traumatic Stress Disorder [PTSD], or depression).
- Any focal neurological 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 and uncontrolled hypertensive, cardiac, pulmonary, vascular, metabolic or hematologic conditions.
- 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.
- History of familial early onset dementia.
Where it is running
- Center for Brain Health, Silberstein Institute, New York University School of Medicine — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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