StrokePhase 1NCT00457769
Aricept to Improve Functional Tasks in Vascular Dementia
A Phase 1 study testing Donepezil and self-generated memory training and Donepezil and experimenter-administered memory training in people with Stroke and Vascular Dementia, run by Kessler Foundation at 1 site in United States.
Trial summary
Medications for memory improvement are available but they may not actually improve the ability to do real world tasks. The purpose of this research study is to determine if a medicine used to treat memory problems donepezil(Aricept) enhances the ability to remember steps of functional tasks and the actual ability to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Vascular Dementia, Memory Deficits
- What is being tested?
- Donepezil and self-generated memory training and Donepezil and experimenter-administered memory training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2021
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I am 18 to100 yrs old.
- I had one stroke 4 months to 5 yrs ago
- I am not taking Aricept or other cholinesterase inhibitors (e.g. Exelon, Razadyne) or memantine (Namenda).
Who cannot join
- I have history of dementia and or have been diagnosed with a memory disorder prior to my stroke.
- I have been on anti-depressants or other cognitive enhancing drugs for less than 3 months and the dose is not stabilized yet.
- I consume alcohol more than or equivalent of 4 ounces hard liquor weekly.
- I am taking oral anticholinergic medications like Bethanechol, Bentyl or Detrol.
- I am a woman of childbearing potential or I am pregnant or a nursing mother.
- I have a history of chronic vomiting or diarrhea.
- I am allergic to Aricept.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Aricept Plus a Behavioral Strategy to Improve Functional Tasks in Vascular Dementia
Medications for memory improvement are available but they may not actually improve the ability to do real world tasks. The purpose of this research study is to determine if a medicine used to treat memory problems donepezil(Aricept) enhances the ability to remember steps of functional tasks and the actual ability to perform tasks relevant to real-life independence. Aricept is an FDA approved medication for the treatment of Alzheimer's disease. Aricept is an investigational drug for the purposes of this study, and is not approved for this purpose.
Read the detailed description
All participants will receive a behavioral intervention as part of the testing protocol: they will be asked to generate words to complete a phrase as they read written steps to perform functional tasks. Mood will be assessed using the Geriatric Depression Scale.(see page 8) Participants will be asked to estimate their memory, immediate attention mood, functional tasks (performing cooking and financial task) and "ability to take medications correctly" (pre-test or "offline" ratings, abstract judgments of their own ability not based directly on performance). They will perform self-assessments of their cognitive, functional abilities and mood using Likert scales. They will mark each of 5 vertical (23.5 cm) lines centered on white paper to indicate their ability. Each line will be labeled for each domain.
To estimate of naming ability, show the subject the Likert Scale (attached) for the naming domain. Then explain: "This scale is to measure how well you think your ability to name. Here is the top where you will mark if you think your performance is perfect, here is the bottom if you think you are terrible. You may be somewhere in between. (broadly indicated the whole middle area) mark where you think your performance would belong on this scale".
This standard protocol will be used by the examiner in this study to explain each domain with specific types of tasks, and give subjects practical hypothetical examples of good and poor performance.
Ability to take medication: Functional memory as applied to medication compliance will be assessed with the Hopkins Medication Schedule (HMS). This test has two part, HMS and pill box. The test will serve as a good evaluation of subject's functional memory, which we suspect it will be most strongly affected by Anosognosia.
The HMS: the participant was read (and read along with) a hypothetical scenario in which her physician gave her 1 prescription for an antibiotic and for aspirin to treat an infection along with directions for taking each. The participant was then asked to plan a schedule for taking these medications and water during the course of a day, following the instructions provided.
- Conditions
- Stroke, Vascular Dementia, Memory Deficits
- Being tested
- Donepezil and self-generated memory training, Donepezil and experimenter-administered memory training
- Keywords
- Aricept, Donepezil, Memory, vascular dementia, stroke, functional tasks, self-generation
- Medical subject headings
- Stroke, Dementia, Vascular, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil and self-generated memory trainingDrug
Also called Aricept
Aricept 5 mg PO qd for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
Donepezil and experimenter-administered memory trainingDrug
Also called Aricept
Aricept 5 mg PO daily for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aricept- A | Experimental | Half of subjects are randomized to immediate treatment with donepezil 5mg orally daily following baseline testing, with retesting at 12 and 24 weeks. Receives: Drug: Donepezil and self-generated memory training; Drug: Donepezil and experimenter-administered memory training |
| A2-12-week waiting period | Experimental | The remaining nine subjects are randomized to testing followed by a 12-week waiting period. After the 12 week wait, this group of subjects is retested and begins taking donepezil, 5 mg orally daily, with retesting at 24 weeks Receives: Drug: Donepezil and self-generated memory training; Drug: Donepezil and experimenter-administered memory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: To examine whether taking Aricept results in improvement at remembering steps of functional tasks.
Measured: 12 weeks
Secondary outcomes (1)
To examine whether taking Aricept and actually performing functional tasks improves memory over that provided by a self-generation strategy.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, A. M. Barrett, MD, Kessler Foundation
- Investigators
- A. M. Barrett, MD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457769
- Sponsor's protocol ID
- AMBarrett2
- Status last verified
- Feb 2021
- First submitted
- 5 Apr 2007
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goverover Y, Chiaravalloti N, DeLuca J. The relationship between self-awareness of neurobehavioral symptoms, cognitive functioning, and emotional symptoms in multiple sclerosis. Mult Scler. 2005 Apr;11(2):203-12. doi: 10.1191/1352458505ms1153oa.
PubMed 15794396
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Aricept Plus a Behavioral Strategy to Improve Functional Tasks in Vascular Dementia
- ClinicalTrials.gov ID
- NCT00457769
- Acronym / sponsor ID
- AMBarrett2
- Conditions
- Stroke, Vascular Dementia, Memory Deficits
- Keywords
- Aricept, Donepezil, Memory, vascular dementia, stroke, functional tasks, self-generation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2007
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Apr 2007 (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.
Medications for memory improvement are available but they may not actually improve the ability to do real world tasks. The purpose of this research study is to determine if a medicine used to treat memory problems donepezil(Aricept) enhances the ability to remember steps of functional tasks and the actual ability to perform tasks relevant to real-life independence. Aricept is an FDA approved medication for the treatment of Alzheimer's disease. Aricept is an investigational drug for the purposes of this study, and is not approved for this purpose.
Detailed description
All participants will receive a behavioral intervention as part of the testing protocol: they will be asked to generate words to complete a phrase as they read written steps to perform functional tasks. Mood will be assessed using the Geriatric Depression Scale.(see page 8) Participants will be asked to estimate their memory, immediate attention mood, functional tasks (performing cooking and financial task) and "ability to take medications correctly" (pre-test or "offline" ratings, abstract judgments of their own ability not based directly on performance). They will perform self-assessments of their cognitive, functional abilities and mood using Likert scales. They will mark each of 5 vertical (23.5 cm) lines centered on white paper to indicate their ability. Each line will be labeled for each domain.
To estimate of naming ability, show the subject the Likert Scale (attached) for the naming domain. Then explain: "This scale is to measure how well you think your ability to name. Here is the top where you will mark if you think your performance is perfect, here is the bottom if you think you are terrible. You may be somewhere in between. (broadly indicated the whole middle area) mark where you think your performance would belong on this scale".
This standard protocol will be used by the examiner in this study to explain each domain with specific types of tasks, and give subjects practical hypothetical examples of good and poor performance.
Ability to take medication: Functional memory as applied to medication compliance will be assessed with the Hopkins Medication Schedule (HMS). This test has two part, HMS and pill box. The test will serve as a good evaluation of subject's functional memory, which we suspect it will be most strongly affected by Anosognosia.
The HMS: the participant was read (and read along with) a hypothetical scenario in which her physician gave her 1 prescription for an antibiotic and for aspirin to treat an infection along with directions for taking each. The participant was then asked to plan a schedule for taking these medications and water during the course of a day, following the instructions provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aricept- A | Experimental | Drug: Donepezil and self-generated memory training, Drug: Donepezil and experimenter-administered memory trainingHalf of subjects are randomized to immediate treatment with donepezil 5mg orally daily following baseline testing, with retesting at 12 and 24 weeks. |
| A2-12-week waiting period | Experimental | Drug: Donepezil and self-generated memory training, Drug: Donepezil and experimenter-administered memory trainingThe remaining nine subjects are randomized to testing followed by a 12-week waiting period. After the 12 week wait, this group of subjects is retested and begins taking donepezil, 5 mg orally daily, with retesting at 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- I am 18 to100 yrs old.
- I had one stroke 4 months to 5 yrs ago
- I am not taking Aricept or other cholinesterase inhibitors (e.g. Exelon, Razadyne) or memantine (Namenda).
Key exclusion criteria (7 listed)
- I have history of dementia and or have been diagnosed with a memory disorder prior to my stroke.
- I have been on anti-depressants or other cognitive enhancing drugs for less than 3 months and the dose is not stabilized yet.
- I consume alcohol more than or equivalent of 4 ounces hard liquor weekly.
- I am taking oral anticholinergic medications like Bethanechol, Bentyl or Detrol.
- I am a woman of childbearing potential or I am pregnant or a nursing mother.
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 and self-generated memory trainingAlso: AriceptAricept 5 mg PO qd for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks | Drug | A2-12-week waiting period, Aricept- A |
| Donepezil and experimenter-administered memory trainingAlso: AriceptAricept 5 mg PO daily for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks | Drug | A2-12-week waiting period, Aricept- A |
Primary outcome
Primary: To examine whether taking Aricept results in improvement at remembering steps of functional tasks.
Time frame: 12 weeks
1 secondary outcome
To examine whether taking Aricept and actually performing functional tasks improves memory over that provided by a self-generation strategy.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Background: PubMed 15794396Goverover Y, Chiaravalloti N, DeLuca J. The relationship between self-awareness of neurobehavioral symptoms, cognitive functioning, and emotional symptoms in multiple sclerosis. Mult Scler. 2005 Apr;11(2):203-12. doi: 10.1191/1352458505ms1153oa.
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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.
A. M. Barrett, MD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Donepezil and self-generated memory training and Donepezil and experimenter-administered memory training in people with Stroke and Vascular Dementia, run by Kessler Foundation 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 Feb 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Primary: To examine whether taking Aricept results in improvement at remembering steps of functional tasks. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00457769, which also lists 1 linked publication.
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 17 Feb 2021.