Memory DisordersNCT00043589
Memory and Mental Health in Aging
A study testing donepezil and Memory-training class in people with Memory Disorders, run by Stanford University at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of donepezil (Aricept®) and cognitive training in improving memory performance in elderly adults. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Disorders
- What is being tested?
- donepezil and Memory-training class
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant neurologic disease
- Possible or probable Alzheimer's Disease (AD)
- Parkinson's disease
- Multi-infarct dementia
- Huntington's disease
- Normal pressure hydrocephalus
Show all 27Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Aging Clinical Research Center, VA Palo Alto Health Care System
Palo Alto, California, 94305
About this study
This study will evaluate the effectiveness of donepezil (Aricept®) and cognitive training in improving memory performance in elderly adults.
Read the 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.
- Conditions
- Memory Disorders
- Being tested
- donepezil, Memory-training class
- Keywords
- Memory
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donepezilDrug
Memory-training classProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2002 (estimated)
- Study startJun 2002
- Primary completionDec 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043589
- Sponsor's protocol ID
- R01MH035182
- Other IDs
- R01MH035182
- Status last verified
- Dec 2013
- First submitted
- 9 Aug 2002
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory and Mental Health in Aging
- ClinicalTrials.gov ID
- NCT00043589
- Acronym / sponsor ID
- R01MH035182
- Conditions
- Memory Disorders
- Keywords
- Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (27 listed)
- Significant neurologic disease
- Possible or probable Alzheimer's Disease (AD)
- Parkinson's disease
- Multi-infarct dementia
- Huntington's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| donepezil | Drug | – |
| Memory-training class | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing donepezil and Memory-training class in people with Memory Disorders, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013.