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Memory and Mental Health in Aging

Primary Purpose

Memory Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
donepezil
Memory-training class
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Memory Disorders focused on measuring Memory

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Aging Clinical Research Center, VA Palo Alto Health Care System

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 9, 2002
Last Updated
December 3, 2013
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00043589
Brief Title
Memory and Mental Health in Aging
Official Title
Memory and Mental Health in Aging
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders
Keywords
Memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
donepezil
Intervention Type
Procedure
Intervention Name(s)
Memory-training class

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Aging Clinical Research Center, VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Memory and Mental Health in Aging

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