Status:
COMPLETED
Brain Imaging and Mental Disorders of Aging Intervention
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Cognition Disorders
Eligibility:
All Genders
40-90 years
Phase:
PHASE4
Brief Summary
The goal of this project is to determine if a cholinesterase inhibitor is more effective than placebo in delaying cognitive and brain functional decline in people at risk for Alzheimer's disease.
Detailed Description
Studies to date show that pictures of the brain using PET (positron emission tomography) scan measures predict memory decline in people with genetic risks for developing AD. They have also been shown ...
Eligibility Criteria
Inclusion
- Agreement to participate in a 18 month clinical trial
- NIMH diagnostic criteria for age-associated memory impairment (AAMI)
- Age 40 to 90 years
- MMSE score between 24 and 30 (unless \< 8 years of educational achievement)
- No significant cerebrovascular disease - modified Ischemic Score of \< 4
- The following medications are allowed if stable for \> 1 month: antidepressants (without anticholinergic effects) if not currently depressed and no history of major depression for 2 years; estrogen replacement therapy; thyroid replacement therapy as long as patient is euthyroid
- On entering the study, there must be a family member or potential caregiver available in case the patient develops cognitive impairment that interferes with independent study participation.
- Memory and verbal fluency cut-off scores increasing the probability of incipient dementia (Buschke-Fuld - 34; verbal fluency - 46 for letters, 7 for categories; Benton Visual Retention - 5)
- Adequate visual and auditory acuity to allow neuropsychological testing
- Screening laboratory tests and ECG without significant abnormalities that might interfere with the study
Exclusion
- Diagnosis of possible or probable AD or any other dementia (e.g., vascular, Lewy body, frontotemporal)
- Evidence of neurologic or other physical illness that could produce cognitive deterioration, including Parkinson's disease; volunteers with a history of TIAs, carotid bruits, or lacunes on MRI scan will be excluded
- History of myocardial infarction within the previous year or unstable cardiac disease
- Uncontrolled hypertension, history of significant liver disease, clinically significant pulmonary disease, diabetes, or cancer
- Such current major psychiatric disorders as mania, according to DSMIV criteria, within the previous two years
- Current diagnosis or history of alcoholism or drug dependence
- Evidence of untreated depression
- Use of any of the following drugs: centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, antipsychotics, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, or warfarin; vitamins other than the standard multivitamin supplement, ginkgo biloba, and any nutraceuticals will not be allowed; once enrolled in the study, occasional chloral hydrate use will be allowed, but discouraged, for insomnia
- Use of any investigational drugs within the previous month or longer, depending on drug half-life
- Contraindication for MRI scan (e.g., metal in body, claustrophobia)
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00267163
Start Date
September 1 2000
End Date
July 1 2007
Last Update
August 29 2008
Active Locations (1)
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1
UCLA, The Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, United States, 90024