Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
200 participants
INTERVENTIONAL
2002-06-30
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
donepezil
Memory-training class
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
55 Years
90 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aging Clinical Research Center, VA Palo Alto Health Care System
Palo Alto, California, United States
Countries
Review the countries where the study has at least one active or historical site.