MemoryPhase 4NCT02988908
Memory and Mental Health in Aging
A Phase 4 study testing Donepezil in people with Memory, run by Stanford University at 1 site in United States.
Trial summary
A comparison of memory training with and without donepezil. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory
- What is being tested?
- Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to Sep 2007
- Phase
- Phase 4
- 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
- Study 1 only:
- Global Clinical Dementia Rating (CDR) 0.0 or 0.5, at least 1 Box score = 0.5 and none > 0.5;
- Laboratory normal B12, RPR, and Thyroid Function Tests or without any clinically significant abnormalities that would be expected to interfere with the study, plus general clinical chemistry and complete blood count.
- ECG without clinically significant abnormalities that would be expected to interfere with the study
- Study 1 and Study 2:
- Mini-Mental Exam score between 24 and 30 (inclusive);
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- General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's Disease cannot be made by the site physician at the time of the screening visit;
- Permitted medications stable for at least 1 month prior to screening. In particular: a) Subjects may take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 2 years). b) Estrogen replacement therapy is permissible. c) Ginkgo biloba is permissible, but discouraged.
- Hamilton Depression Score less than or equal to 12 on the 17-item scale.
- Visual and auditory acuity adequate to allow neuropsychological testing.
- General health good with no additional diseases expected to interfere with the study.
- Women two years post-menopausal or surgically sterile.
Who cannot join
- Any significant neurologic disease such as Possible and Probable AD, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- Major depression or another major psychiatric disorder as described in DSM IV within the past 2 years. History of schizophrenia (DSM IV criteria). Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
- History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including:
- History of systemic cancer within the last 5 years (non-metastatic skin cancers are acceptable).
- History of myocardial infarction within the past year or unstable or severe cardiovascular disease including angina or CHF with symptoms at rest.
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- Clinically significant obstructive pulmonary disease or asthma.
- Clinically significant and unstable gastrointestinal disorder such as ulcer disease or a history of active or occult gastrointestinal bleeding within two years.
- Insulin-requiring diabetes or uncontrolled diabetes mellitus.
- Uncontrolled hypertension (systolic BP greater than 170 or diastolic greater than 100).
- 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. b) Use of anti-Parkinsonian medications (e.g. Sinemet, amantadine, bromocriptine, pergolide and selegiline) within 2 months prior to screening. c) Use of neuroleptics or narcotic analgesics within 4 weeks prior to screening. d) Use of long-acting benzodiazepines or barbiturates within 4 weeks prior to screening. e) 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). f) 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). g) Use of systemic corticosteroids within 3 months prior to screening. h) Medications with significant cholinergic or anticholinergic side effects (e.g. pyridostigmine, tricyclic antidepressants, meclizine, and oxybutynin) within 4 weeks prior to screening. i) Use of anti-convulsants (e.g. Phenytoin, Phenobarbital, Carbamazepine) within 2 months prior to screening. j) Use of warfarin (Coumadin) within 4 weeks prior to screening.
- Any prior use of any FDA approved medications for the treatment of Alzheimer's Disease (e.g. tacrine, donepezil, or other newly approved medications).
- Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: Memory and Mental Health in Aging: Psychopharmacological Augmentation of Memory Training in Older Adults
A comparison of memory training with and without donepezil.
Read the detailed description
Study 1:
Investigators evaluated the short-term and longer-term efficacy and effectiveness of a pharmacologic augmentation strategy for a nonpharmacologic treatment to improve memory performance in nondemented older adults. Investigators used a randomized controlled trial with parallel groups design that compares two Treatments: DONEPEZIL + COGNITIVE TRAINING versus PLACEBO + COGNITIVE TRAINING.
Study 2:
The second study looked more closely at dosage. Investigators hoped to determine the best dosage of the drug donepezil for enhancing the effects of the memory training program.
- Conditions
- Memory
- Being tested
- Donepezil, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Also called Aricept
Participants received donepezil as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
Participants also received 2 weeks of memory training at weeks 13-14
PlacebosDrug
Also called Control
Participants received placebo as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
Participants also received 2 weeks of memory training at weeks 13-14
| Study group | Role | What they receive |
|---|---|---|
| Drug: Donepezil | Experimental | Participants received Donepezil as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
Participants also received 2 weeks of memory training at weeks 13-14 Receives: Drug: Donepezil |
| Placebo (Control) | Placebo comparator | Participants received placebo as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
Participants also received 2 weeks of memory training at weeks 13-14 Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in recall of Word List over time
Each participant was given a list of 16 words. Participants had 4 minutes to memorize the words in order. Short-term recall was tested after 5 minutes exposure to a distractor task and delayed recall was tested after 30 minutes. At recall participants were asked to recall as many words as they could remember in the order the words were presented.
Measured: measured at baseline, Week 13 (before training), Week 14 (at end of training), and Week 52
Change in recall of Name-Face pairs over time
Each participant was shown 12 name-face pairs for 1 minute. Recall was tested immediately after presentation of all 12 name-face pairs (faces were shown for 1 minute and participant was asked to supply the name).
Measured: measured at baseline, Week 13 (before training), Week 14 (at end of training), and Week 52
Secondary outcomes (4)
Change in Symbol Digit score over time
Symbol Digit modalities test (Smith 1991)
Measured: measured at baseline, Week 13, and Week 52
Change in Digit Span score over time
Digit Span from the Wechsler, 1987
Measured: measured at baseline, Week 13, and Week 52
Change in Medical Outcomes Study Functioning and Well-being Profile over time
Measuring Functioning and Well-Being is a comprehensive account of a broad range of self-reported functioning and well-being measures developed for the Medical Outcomes Study (Stewart AL, 1992)
Measured: measured at baseline, Week 13, and Week 52
Change in Everyday Problems Test score over time
Measure of Functional Capacity (Willis SL, Mariske M, 1993)
Measured: measured at baseline, Week 13 (before training), and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startApr 2000
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MemoryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jerome A Yesavage,, Stanford University
- Investigators
- Jerome A Yesavage, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988908
- Sponsor's protocol ID
- SU-06302009-2820
- Other IDs
- R01MH035182, eprotocol #7530
- Status last verified
- Dec 2016
- First submitted
- 11 May 2010
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory and Mental Health in Aging: Psychopharmacological Augmentation of Memory Training in Older Adults
- ClinicalTrials.gov ID
- NCT02988908
- Acronym / sponsor ID
- SU-06302009-2820
- Conditions
- Memory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2000
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 9 Dec 2016 (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.
A comparison of memory training with and without donepezil.
Detailed description
Study 1:
Investigators evaluated the short-term and longer-term efficacy and effectiveness of a pharmacologic augmentation strategy for a nonpharmacologic treatment to improve memory performance in nondemented older adults. Investigators used a randomized controlled trial with parallel groups design that compares two Treatments: DONEPEZIL + COGNITIVE TRAINING versus PLACEBO + COGNITIVE TRAINING.
Study 2:
The second study looked more closely at dosage. Investigators hoped to determine the best dosage of the drug donepezil for enhancing the effects of the memory training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Donepezil | Experimental | Drug: DonepezilParticipants received Donepezil as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial. Participants also received 2 weeks of memory training at weeks 13-14 |
| Placebo (Control) | Placebo comparator | Drug: PlacebosParticipants received placebo as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial. Participants also received 2 weeks of memory training at weeks 13-14 |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Global Clinical Dementia Rating (CDR) 0.0 or 0.5, at least 1 Box score = 0.5 and none > 0.5;
- Laboratory normal B12, RPR, and Thyroid Function Tests or without any clinically significant abnormalities that would be expected to interfere with the study, plus general clinical chemistry and complete blood count.
- ECG without clinically significant abnormalities that would be expected to interfere with the study
- Mini-Mental Exam score between 24 and 30 (inclusive);
- General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's Disease cannot be made by the site physician at the time of the screening visit;
Key exclusion criteria (14 listed)
- Any significant neurologic disease such as Possible and Probable AD, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- Major depression or another major psychiatric disorder as described in DSM IV within the past 2 years. History of schizophrenia (DSM IV criteria). Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
- History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including:
- Use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4 weeks prior to screening. b) Use of anti-Parkinsonian medications (e.g. Sinemet, amantadine, bromocriptine, pergolide and selegiline) within 2 months prior to screening. c) Use of neuroleptics or narcotic analgesics within 4 weeks prior to screening. d) Use of long-acting benzodiazepines or barbiturates within 4 weeks prior to screening. e) 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). f) 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). g) Use of systemic corticosteroids within 3 months prior to screening. h) Medications with significant cholinergic or anticholinergic side effects (e.g. pyridostigmine, tricyclic antidepressants, meclizine, and oxybutynin) within 4 weeks prior to screening. i) Use of anti-convulsants (e.g. Phenytoin, Phenobarbital, Carbamazepine) within 2 months prior to screening. j) Use of warfarin (Coumadin) within 4 weeks prior to screening.
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 |
|---|---|---|
| DonepezilAlso: AriceptParticipants received donepezil as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial. Participants also received 2 weeks of memory training at weeks 13-14 | Drug | Drug: Donepezil |
| PlacebosAlso: ControlParticipants received placebo as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial. Participants also received 2 weeks of memory training at weeks 13-14 | Drug | Placebo (Control) |
Primary outcome
Change in recall of Word List over time
Time frame: measured at baseline, Week 13 (before training), Week 14 (at end of training), and Week 52
Each participant was given a list of 16 words. Participants had 4 minutes to memorize the words in order. Short-term recall was tested after 5 minutes exposure to a distractor task and delayed recall was tested after 30 minutes. At recall participants were asked to recall as many words as they could remember in the order the words were presented.
Change in recall of Name-Face pairs over time
Time frame: measured at baseline, Week 13 (before training), Week 14 (at end of training), and Week 52
Each participant was shown 12 name-face pairs for 1 minute. Recall was tested immediately after presentation of all 12 name-face pairs (faces were shown for 1 minute and participant was asked to supply the name).
4 secondary outcomes
Change in Symbol Digit score over time
Time frame: measured at baseline, Week 13, and Week 52
Change in Digit Span score over time
Time frame: measured at baseline, Week 13, and Week 52
Change in Medical Outcomes Study Functioning and Well-being Profile over time
Time frame: measured at baseline, Week 13, and Week 52
Change in Everyday Problems Test score over time
Time frame: measured at baseline, Week 13 (before training), and Week 52
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 10 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Jerome A Yesavage principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil in people with Memory, 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 12 inclusion and 14 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 10 Feb 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Change in recall of Word List over time (time frame: measured at baseline, Week 13 (before training), Week 14 (at end of training), and Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 10 Feb 2017.