Aricept to Improve Functional Tasks in Vascular Dementia

NCT00457769

Last updated date
Study Location
Kessler Foundation
West Orange, New Jersey, 08902, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Stroke, Vascular Dementia, Memory Deficits
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Stroke, Vascular Dementia, Memory DeficitsAricept to Improve Functional Tasks in Vascular Dementia
NCT00457769
  1. West Orange, New Jersey
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Aricept to Improve Functional Tasks in Vascular Dementia
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Vascular Dementia
  • Memory Deficits
Intervention  ICMJE
  • Drug: Donepezil and self-generated memory training
    Aricept 5 mg PO qd for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
    Other Name: Aricept
  • Drug: Donepezil and experimenter-administered memory training
    Aricept 5 mg PO daily for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks
    Other Name: Aricept
Study Arms  ICMJE
  • Experimental: Aricept- A
    Half of subjects are randomized to immediate treatment with donepezil 5mg orally daily following baseline testing, with retesting at 12 and 24 weeks.
    Interventions:
    • Drug: Donepezil and self-generated memory training
    • Drug: Donepezil and experimenter-administered memory training
  • 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 donepezil, 5 mg orally daily, with retesting at 24 weeks
    Interventions:
    • Drug: Donepezil and self-generated memory training
    • Drug: Donepezil and experimenter-administered memory training
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2007)
18
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00457769
Other Study ID Numbers  ICMJE AMBarrett2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party A. M. Barrett, MD, Kessler Foundation
Study Sponsor  ICMJE Kessler Foundation
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:A. M. Barrett, MDKessler Foundation
PRS Account Kessler Foundation
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP