Aricept to Improve Functional Tasks in Vascular Dementia

NCT00457769 | Unknown Phase 1 DMC

• 1 other identifier: AMBarrett2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Vascular Dementia; Memory Deficits

Keywords

Aricept; Donepezil; Memory; vascular dementia; stroke; functional tasks; self-generation

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (1)

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

  24 weeks

Study Arms (2)

Aricept- A

EXPERIMENTAL

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

Drug: Donepezil and self-generated memory training; Drug: Donepezil and experimenter-administered memory training

A2-12-week waiting period

EXPERIMENTAL

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

Drug: Donepezil and self-generated memory training; Drug: Donepezil and experimenter-administered memory training

Interventions

Donepezil and self-generated memory training DRUG

Aricept 5 mg PO qd for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks

Also known as: Aricept

A2-12-week waiting period; Aricept- A

Donepezil and experimenter-administered memory training DRUG

Aricept 5 mg PO daily for 4 weeks followed by Aricept 10 mg PO qd for 8 weeks

Also known as: Aricept

A2-12-week waiting period; Aricept- A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• Pfizer: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 08902, United States

Location

Related Publications (1)

• 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.

  PMID: 15794396 BACKGROUND

Related Links

• Stroke page on Kessler Foundation website

MeSH Terms

Conditions

Stroke; Dementia, Vascular; Memory Disorders

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• A. M. Barrett, MD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Stroke Rehabilitation Research

Study Record Dates

• First Submitted: April 5, 2007
• First Posted: April 6, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

US (1)