Brain Imaging and Mental Disorders of Aging Intervention
Cognition Disorders
About this trial
This is an interventional prevention trial for Cognition Disorders focused on measuring Alzheimer's disease, Mild Cognitive Impairment
Eligibility 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)
Sites / Locations
- UCLA, The Semel Institute for Neuroscience and Human Behavior
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
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