Brain Imaging and Mental Disorders of Aging Intervention

Completed · Phase 4 · Has a placebo group

Conditions studied: Cognition Disorders

In brief

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.

Key facts

Study ID

NCT00267163

Run by

National Institute on Aging (NIA)

People needed

64

Starts

2000-09-01

Expected to finish

2007-07-01

Last updated by the study team

2008-08-29

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• UCLA, The Semel Institute for Neuroscience and Human Behavior — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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