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| Sponsor: | Kessler Foundation |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | Kessler Foundation |
| ClinicalTrials.gov Identifier: | NCT00457769 |
Purpose
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 donezepil (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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke Vascular Dementia Memory |
Drug: Donpezil Drug: Donepezil |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase 1 Study of Aricept Plus a Behavioral Strategy to Improve Functional Tasks in Vascular Dementia |
| Estimated Enrollment: | 18 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Half of subjects are randomized to immediate treatment with Aricept following baseline testing, with retesting at 12 and 24 weeks.
|
Drug: Donpezil
Aricept 5 mg PO qd for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
Drug: Donepezil
Aricept 5 mg PO daily for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
|
|
A2: 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 Aricept, with retesting at 24 weeks
|
Drug: Donpezil
Aricept 5 mg PO qd for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
Drug: Donepezil
Aricept 5 mg PO daily for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jenny Masmel, BA | 973-324-3564 | jmasmela@kesslerfoundation.org |
| Contact: Anna M Barrett, MD | 973-324-3563 | abarrett@kesslerfoundation.org |
| United States, New Jersey | |
| Kessler Medical Rehabilitation Research and Education Center | Recruiting |
| West Orange, New Jersey, United States, 08902 | |
| Contact: Jenny Masmela, BA 973-324-3564 jmasmela@kesslerfoundation.org | |
| Contact: Anna Barrett, MD 973-324-3563 abarrett@kesslerfoundation.org | |
| Kessler Medical Rehabilitation Research and Education Center | Recruiting |
| West Orange, New Jersey, United States, 08902 | |
| Contact: Jenny Masmela, BA 973-324-3564 jmasmela@kesslerfoundation.org | |
| Principal Investigator: | Anna M Barrett, MD | Kessler Foundation |
More Information
| Responsible Party: | Kessler Medical Rehabilitation Research Center ( Dr. Barrett, Principal Investigator ) |
| Study ID Numbers: | AMBarrett2 |
| Study First Received: | April 5, 2007 |
| Last Updated: | October 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00457769 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Aricept Donepezil Memory vascular dementia |
stroke functional tasks self-generation |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Arteriosclerosis Brain Diseases Cholinergic Agents Intracranial Arterial Diseases Cerebrovascular Disorders Intracranial Arteriosclerosis Mental Disorders Therapeutic Uses Donepezil Dementia, Vascular |
Cardiovascular Diseases Dementia Arterial Occlusive Diseases Nootropic Agents Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Agents |
