Status:
UNKNOWN
Biomarkers and Early Alzheimer's Disease
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60-80 years
Brief Summary
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 earlie...
Detailed Description
The goal of this project is to use magnetic resonance imaging (MRI) and cerebrospinal fluid (CSF) biomarkers to identify cognitively normal participants who show the earliest clinically detectable bra...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00094952
Start Date
April 1 2003
End Date
March 1 2008
Last Update
September 18 2009
Active Locations (1)
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1
Center for Brain Health, Silberstein Institute, New York University School of Medicine
New York, New York, United States, 10016