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Aricept to Improve Functional Tasks in Vascular Dementia

Primary Purpose

Stroke, Vascular Dementia, Memory Deficits

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Donepezil and self-generated memory training
Donepezil and experimenter-administered memory training
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Aricept, Donepezil, Memory, vascular dementia, stroke, functional tasks, self-generation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aricept- A

A2-12-week waiting period

Arm Description

Half of subjects are randomized to immediate treatment with donepezil 5mg orally daily following baseline testing, with retesting at 12 and 24 weeks.

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

Outcomes

Primary Outcome Measures

Primary: To examine whether taking Aricept results in improvement at remembering steps of functional tasks.

Secondary Outcome Measures

To examine whether taking Aricept and actually performing functional tasks improves memory over that provided by a self-generation strategy.

Full Information

First Posted
April 5, 2007
Last Updated
February 16, 2021
Sponsor
Kessler Foundation
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00457769
Brief Title
Aricept to Improve Functional Tasks in Vascular Dementia
Official Title
Phase 1 Study of Aricept Plus a Behavioral Strategy to Improve Functional Tasks in Vascular Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Vascular Dementia, Memory Deficits
Keywords
Aricept, Donepezil, Memory, vascular dementia, stroke, functional tasks, self-generation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aricept- A
Arm Type
Experimental
Arm Description
Half of subjects are randomized to immediate treatment with donepezil 5mg orally daily following baseline testing, with retesting at 12 and 24 weeks.
Arm Title
A2-12-week waiting period
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Donepezil and self-generated memory training
Other Intervention Name(s)
Aricept
Intervention Description
Aricept 5 mg PO qd for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Donepezil and experimenter-administered memory training
Other Intervention Name(s)
Aricept
Intervention Description
Aricept 5 mg PO daily for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
Primary Outcome Measure Information:
Title
Primary: To examine whether taking Aricept results in improvement at remembering steps of functional tasks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To examine whether taking Aricept and actually performing functional tasks improves memory over that provided by a self-generation strategy.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. M. Barrett, MD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
08902
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15794396
Citation
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.
Results Reference
background
Links:
URL
https://kesslerfoundation.org/researchcenter/stroke/index.php
Description
Stroke page on Kessler Foundation website

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Aricept to Improve Functional Tasks in Vascular Dementia

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