Improving Memory in Patients With Multiple Sclerosis

This study has been withdrawn prior to enrollment.

(Study terminated/withdrawn)

Sponsor:

Collaborator:

U.S. Department of Education

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT00062972

First received: June 18, 2003

Last updated: May 20, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 18, 2003

Last Updated Date

May 20, 2011

Start Date ^ICMJE

September 1999

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00062972 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Improving Memory in Patients With Multiple Sclerosis

Official Title ^ICMJE

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

Drug: donepezil
Drug: glucose

Study Arm (s)

Not Provided

Publications *

Prosiegel M, Michael C. Neuropsychology and multiple sclerosis: diagnostic and rehabilitative approaches. J Neurol Sci. 1993 Apr;115 Suppl:S51-4.
Rudick R, Antel J, Confavreux C, Cutter G, Ellison G, Fischer J, Lublin F, Miller A, Petkau J, Rao S, Reingold S, Syndulko K, Thompson A, Wallenberg J, Weinshenker B, Willoughby E. Clinical outcomes assessment in multiple sclerosis. Ann Neurol. 1996 Sep;40(3):469-79. Review.
Wild KV, Lezak MD,Whitman RH, Bourdette DN: Psychosocial impact of cognitive impairment in the multiple sclerosis patient. J Clin Exp Neuropsychology 415: 685-691, 1991
Krupp LB, Sliwinski M, Masur DM, Friedberg F, Coyle PK. Cognitive functioning and depression in patients with chronic fatigue syndrome and multiple sclerosis. Arch Neurol. 1994 Jul;51(7):705-10.
Kujala P, Portin R, Revonsuo A, Ruutiainen J. Attention related performance in two cognitively different subgroups of patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 1995 Jul;59(1):77-82.

* 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

Withdrawn

Estimated Enrollment ^ICMJE

Completion Date

August 2002

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00062972

Other Study ID Numbers ^ICMJE

1R01 HD38107-01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

U.S. Department of Education

Investigators ^ICMJE

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

May 2011

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

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