Aricept to Improve Functional Tasks in Vascular Dementia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Anna M. Barrett, MD, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00457769
First received: April 5, 2007
Last updated: May 1, 2013
Last verified: May 2013
  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 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.


Condition Intervention Phase
Stroke
Vascular Dementia
Memory Deficits
Drug: Donepezil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Aricept Plus a Behavioral Strategy to Improve Functional Tasks in Vascular Dementia

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • Primary: To examine whether taking Aricept results in improvement at remembering steps of functional tasks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: May 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aricept- A
Half of subjects are randomized to immediate treatment with Donepezil following baseline testing, with retesting at 12 and 24 weeks.
Drug: Donepezil
Aricept 5 mg PO qd for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
Other Name: Aricept
Drug: Donepezil
Aricept 5 mg PO daily for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
Other Name: Aricept
Experimental: A2-12-week waiting period
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: Donepezil
Aricept 5 mg PO qd for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
Other Name: Aricept
Drug: Donepezil
Aricept 5 mg PO daily for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
Other Name: Aricept

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457769

Locations
United States, New Jersey
Kessler Medical Rehabilitation Research and Education Center
West Orange, New Jersey, United States, 08902
Sponsors and Collaborators
Kessler Foundation
Pfizer
Investigators
Principal Investigator: Anna M Barrett, MD Kessler Foundation
  More Information

Additional Information:
Publications:
Responsible Party: Anna M. Barrett, MD, Director, Stroke Rehabilitation Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT00457769     History of Changes
Other Study ID Numbers: AMBarrett2
Study First Received: April 5, 2007
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Kessler Foundation:
Aricept
Donepezil
Memory
vascular dementia
stroke
functional tasks
self-generation

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Stroke
Memory Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014