Clinical Trial: Aricept to Improve Functional Tasks in Vascular Dementia
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase 1 Study of Aricept Plus a Behavioral Strategy to Improve Functional Tasks in Vascular Dementia
Brief 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 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 Summary:
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
Sponsor: Kessler Foundation
Current Primary Outcome: Primary: To examine whether taking Aricept results in improvement at remembering steps of functional tasks. [ Time Frame: 12 weeks ]
Original Primary Outcome:
- Primary: In a pilot group of post-stroke patients with VasD and memory and cognitive disorder,
- to examine whether taking Aricept results in improvement at remembering steps of functional tasks,
- and actually performing those tasks, over that provided by a self-generation strategy.
Current 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 ]
Original Secondary Outcome:
- Secondary: To examine whether memory improvement occurs in VasD remembering steps of functional tasks, and
- actually performing prescribed steps of those tasks
Information By: Kessler Foundation
Dates:
Date Received: April 5, 2007
Date Started: May 2007
Date Completion: December 2016
Last Updated: February 22, 2016
Last Verified: February 2016
