Brain Imaging and Mental Disorders of Aging Intervention

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)