Improving Memory in Patients With Multiple Sclerosis

April 21, 2017 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Interventions to Improve Memory in Patients With Multiple Sclerosis

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794-8121
        • University Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

U.S. Department of Education

Investigators

  • Principal Investigator: Lauren B. Krupp, MD, Department of Neurology, University Hospital Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Study Completion

August 1, 2002

Study Registration Dates

First Submitted

June 18, 2003

First Submitted That Met QC Criteria

June 18, 2003

First Posted (Estimate)

June 19, 2003

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HD038107-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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