Memory and Mental Health in Aging

Stanford University

Status

Completed

Conditions

Memory Disorders

Treatments

Drug: donepezil

Procedure: Memory-training class

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00043589

R01MH035182 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will evaluate the effectiveness of donepezil (Aricept®) and cognitive training in improving memory performance in elderly adults.

Full description

The drug donepezil plus cognitive training may work better than cognitive training alone to improve the memory of nondemented older adults. In this study, participants are assigned randomly to receive either donepezil plus cognitive training or placebo plus cognitive training. Memory and quality of life tests are used to evaluate the effects of the study treatments.

Sex

All

Ages

55 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Mini-Mental Exam score between 24 and 30
Hamilton Depression Score of 12 or less on 17-item scale
Visual and auditory acuity adequate for neuropsychological testing
General good health (no additional diseases expected to interfere with the study)
Normal B12, Rapid Plasma Reagin (RPR), and Thyroid Function Tests
Normal general clinical chemistry, complete blood count, and electrocardiogram (ECG)
Female participants must be 2 years postmenopausal or surgically sterile

Exclusion criteria

Significant neurologic disease
Possible or probable Alzheimer's Disease (AD)
Parkinson's disease
Multi-infarct dementia
Huntington's disease
Normal pressure hydrocephalus
Brain tumor
Progressive supranuclear palsy
Seizure disorder
Subdural hematoma
Multiple sclerosis
History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
Major depression or other major psychiatric disorder as described in DSM IV within the past 2 years
Psychotic features, agitation, or behavioral problems within the last 3 months
History of alcohol or substance abuse or dependence within the past 2 years
Significant systemic illness or unstable medical condition including: a) history of systemic cancer within the last 5 years (nonmetastatic skin cancers are acceptable); b) history of myocardial infarction within the past year or unstable or severe cardiovascular disease, including angina or CHF with symptoms at rest; c) clinically significant obstructive pulmonary disease or asthma; d) clinically significant and unstable gastrointestinal disorder such as ulcer disease or a history of active or occult gastrointestinal bleeding within 2 years; e) clinically significant laboratory test abnormalities on the battery of screening tests (hematology, prothrombin time, chemistry, urinalysis, ECG); f) insulin-requiring diabetes or uncontrolled diabetes mellitus; g) uncontrolled hypertension (systolic BP greater than 170 or diastolic greater than 100); h) history of clinically significant liver disease, coagulopathy, or vitamin K deficiency within the past 2 years
Use of centrally active beta-blockers, narcotics, methyldopa, and clonidine within 4 weeks prior to screening
Use of anti-Parkinsonian medications (e.g. Sinemet, amantadine, bromocriptine, pergolide, and selegiline) within 2 months prior to screening
Use of neuroleptics or narcotic analgesics within 4 weeks prior to screening
Use of long-acting benzodiazepines or barbiturates within 4 weeks prior to screening
Use of short-acting anxiolytics or sedative hypnotics more frequently than 2 times per week within 4 weeks prior to screening (note: sedative agents should not be used within 72 hours of screening)
Initiation or change in dose of an antidepressant lacking significant cholinergic side effects within the 4 weeks prior to screening (use of stable doses of antidepressants for at least 4 weeks prior to screening is acceptable)
Use of systemic corticosteroids within 3 months prior to screening
Medications with significant cholinergic or anticholinergic side effects (e.g. pyridostigmine, tricyclic antidepressants, meclizine, and oxybutynin) within 4 weeks prior to screening
Use of anti-convulsants (e.g. Phenytoin, Phenobarbital, Carbamazepine) within 2 months prior to screening
Use of warfarin (Coumadin) within 4 weeks prior to screening
Prior use of any FDA approved medications for the treatment of AD (e.g. tacrine, donepezil, or other newly approved medications)