Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT00065169
Eligibility Criteria:
Inclusion Criteria:
* NIMH diagnostic criteria for Age Associated Memory Impairment (AAMI)
* Mini-Mental State Examination (MMSE) score between 26 and 30 (unless \< 8 years of educational achievement)
* No significant cerebrovascular disease
* Estrogen replacement therapy and thyroid replacement therapy (if the participant is euthyroid) are permitted if the therapies are stable for \> 1 month
* Memory and verbal fluency cut-off scores that increase 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
* Normal screening laboratory tests and electrocardiogram (ECG)
Exclusion Criteria:
* Possible or probable Alzheimer Disease (AD) or other dementia
* Neurologic or other physical illness that could produce cognitive deterioration
* History of transient ischemic attacks (TIAs), carotid bruits, or lacunes on an MRI scan
* History of myocardial infarction within the previous year or unstable cardiac disease
* Uncontrolled hypertension (systolic BP \> 170 or diastolic BP \> 100)
* History of significant liver disease, pulmonary disease, diabetes, or cancer
* DSM-IV criteria for major psychiatric disorders within the previous 2 years
* Past or present history of alcoholism or drug dependence
* Untreated depression as determined by a Hamilton Depression Rating Scale (HAM-D) score of 12 or more
* Drugs that may significantly affect psychometric test results
* Centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, antipsychotics, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, warfarin, vitamins other than the standard multivitamin supplement, ginkgo biloba, and any nutraceuticals. Occasional chloral hydrate use will be allowed, but discouraged, for insomnia.
* Investigational drugs within the previous month or longer, depending on drug half-life
* Contraindication for MRI scan (e.g., metal in body, claustrophobia)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT00065169
Study Brief:
Protocol Section:
NCT00065169