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 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Half of subjects are randomized to immediate treatment with Aricept following baseline testing, with retesting at 12 and 24 weeks.
• Experimental: A2
  • 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

Primary Measures

• Primary: To examine whether taking Aricept results in improvement at remembering steps of functional tasks.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• To examine whether taking Aricept and actually performing functional tasks improves memory over that provided by a self-generation strategy.
  • Time Frame: 24 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. I am 18 to100 yrs old.
• 2. I had one stroke 4 months to 5 yrs ago
• 3. I am not taking Aricept or other cholinesterase inhibitors (e.g. Exelon, Razadyne) or memantine (Namenda).

Exclusion Criteria:

• 1. I have history of dementia and or have been diagnosed with a memory disorder prior to my stroke.
• 2. I have been on anti-depressants or other cognitive enhancing drugs for less than 3 months and the dose is not stabilized yet.
• 3. I consume alcohol more than or equivalent of 4 ounces hard liquor weekly.
• 4. I am taking oral anticholinergic medications like Bethanechol, Bentyl or Detrol.
• 5. I am a woman of childbearing potential or I am pregnant or a nursing mother.
• 6. I have a history of chronic vomiting or diarrhea.
• 7. I am allergic to Aricept.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kessler Medical Rehabilitation Research Center

Overall Clinical Trial Officials and Contacts

Anna M Barrett, MD Principal Investigator Kessler Medical Rehabilitation Research Center  

Overall Contact: Siby Varughese, RN, MA 973-324-3564 svarughese@kmrrec.org

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00457769

Study ID Number: AMBarrett2

ClinicalTrials.gov Identifier: NCT00457769

Health Authority: United States: Food and Drug Administration

Stroke page on KMRREC website