Memory and Mental Health in Aging

Memory Disorders Clinical Trial

Official title:

Memory and Mental Health in Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043589
• Other study ID #: R01MH035182
• Secondary ID: R01MH035182
• Status: Completed
• Phase: N/A
• First received: August 9, 2002
• Last updated: December 3, 2013
• Start date: June 2002
• Est. completion date: December 2007

Study information

• Verified date: December 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Memory Disorders

Intervention

Drug:
• donepezil

Procedure:
• Memory-training class

Locations

Country	Name	City	State
United States	Aging Clinical Research Center, VA Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States,