- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00043589
Memory and Mental Health in Aging
December 3, 2013 updated by: Stanford University
This study will evaluate the effectiveness of donepezil (Aricept®) and cognitive training in improving memory performance in elderly adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94305
- Aging Clinical Research Center, VA Palo Alto Health Care System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
August 9, 2002
First Submitted That Met QC Criteria
August 12, 2002
First Posted (Estimate)
August 13, 2002
Study Record Updates
Last Update Posted (Estimate)
December 5, 2013
Last Update Submitted That Met QC Criteria
December 3, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH035182 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Memory Disorders
-
Memorial Sloan Kettering Cancer CenterCompletedMemory Losses | Amnesia-Memory LossUnited States
-
Fundació Institut de Recerca de l'Hospital de la...CompletedAge-Related Memory Disorders | Memory LossSpain
-
Bradley HospitalRecruitingWorking MemoryUnited States
-
EMSWithdrawn
-
Maharishi Markendeswar University (Deemed to be...Not yet recruitingWorking Memory Deficits
-
Pusan National University Yangsan HospitalCompleted
-
Pusan National University Yangsan HospitalCompletedSubjective Memory ImpairmentKorea, Republic of
-
USDA Human Nutrition Research Center on AgingCalifornia Strawberry CommissionCompletedAging | Age-related Memory DisordersUnited States
-
University of Texas Southwestern Medical CenterTerminatedMood | Memory DeficitUnited States
-
University of California, San DiegoRecruitingCognitive Change | Aging | Mild Cognitive Impairment | Cognitive Decline | Memory Disorders | Memory Impairment | Cognition Disorders in Old Age | Aging Problems | Memory Loss | Memory Disorders in Old Age | Memory Disorder, SpatialUnited States
Clinical Trials on donepezil
-
Eisai Inc.Eisai LimitedCompleted
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Corium, Inc.CompletedAlzheimer DiseaseUnited States
-
Samsung Medical CenterEisai Korea Inc.CompletedDementia | Alzheimer's DiseaseKorea, Republic of
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Eisai Inc.PfizerTerminatedCognitive Dysfunction | Down SyndromeUnited States
-
Eisai Inc.PfizerTerminatedCognitive Dysfunction | Down SyndromeUnited States
-
Eisai Inc.CompletedMigraine HeadacheUnited States
-
The First Affiliated Hospital with Nanjing Medical...Unknown
-
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.Completed