Improving Memory in Patients With Multiple Sclerosis - Tabular View

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

Improving Memory in Patients With Multiple Sclerosis

This study is currently recruiting participants.

Study NCT00062972. Last updated on June 23, 2005. Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Improving Memory in Patients With Multiple Sclerosis

Official Title ^†

Interventions to Improve Memory in Patients With Multiple Sclerosis

Brief Summary

People with multiple sclerosis (MS) suffer from cognitive and other brain problems. This study will examine the effectiveness of the drug donepezil and of sugar water for enhancing memory in individuals with MS. Donepezil (also known as Aricept) has been FDA approved for improving memory and learning in individuals with Alzheimer’s disease.

Detailed Description

Cognitive dysfunction is one of the leading causes of disability in people with MS. Memory involving specific words (verbal memory) is particularly affected in individuals with MS. Attempts to rehabilitate cognitive dysfunction in MS have had only limited success.

This study will determine the efficacy of donepezil therapy and glucose administration for enhancing verbal memory functioning in individuals with MS. The study will also measure secondary outcomes assessing other areas of cognitive dysfunction (i.e., nonverbal memory, conceptual thinking, processing speed) which may improve with intervention.

Forty participants with MS will be randomly assigned to receive either donepezil or placebo for 24 weeks. Participants will complete memory and cognitive tests at the beginning and end of the 24 week period.

Twenty participants with MS will be randomly assigned to drink a beverage sweetened with either glucose or saccharin (placebo). Participants will then complete memory and other cognitive tests. Two weeks later, participants will drink a beverage sweetened with the alternative sweetener and again complete the memory and cognitive tests.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Multiple Sclerosis

Intervention ^†

Drug: donepezil
Drug: glucose

MEDLINE PMIDs

8340793, 8797541, 8018045, 7608714

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

September 1999

Completion Date

August 2002

Eligibility Criteria ^†

Inclusion Criteria

MS as defined by the Poser criteria
Expanded Disability Status Scale (EDSS) score of 0 to 6.5
Stable neurologic function for at least 30 days prior to study entry
Agree to continue all current medications for study duration
Rey Auditory Verbal Learning Test score in low normal range or below
Mini-mental status exam score of 26 or higher
Montgomery-Asberg Depression Scale scaled score of 14 or lower
Fluent in English

Exclusion Criteria

Use of anticholinergic or benzodiazepine medication
Change in dosage of medications judged to have the potential to impact cognitive function (e.g., antispasticity medications) within 2 weeks of study entry
Current alcohol or substance abuse
History of neurological or major medical problem that has a known effect on cognitive functioning
History of noncompliance
Visual or upper extremity impairment which precludes ability to participate in cognitive assessment

Gender

Both

Ages

18 Years to 56 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Patricia Melville, RN

631-444-8164

Pmelvill@neuro.som.sunysb.edu

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00062972

Organization ID

1R01 HD38107-01

Secondary IDs ^††

Study Sponsor ^†

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators ^††

Department of Education

Investigators ^†

Principal Investigator:

Lauren B. Krupp, MD

Department of Neurology, University Hospital Medical Center

Information Provided By

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Verification Date

December 2003

First Received Date ^†

June 18, 2003

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.