Aricept to Improve Functional Tasks in Vascular Dementia



Status:Active, not recruiting
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:8/10/2018
Start Date:May 2007
End Date:December 2019

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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.

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.

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.
We found this trial at
1
site
West Orange, New Jersey 07052
?
mi
from
West Orange, NJ
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