search
Back to results

Improving Memory in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
donepezil
glucose
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Cognitive Dysfunction, Treatment Interventions, Verbal memory deficits

Eligibility Criteria

18 Years - 56 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital and Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 18, 2003
Last Updated
April 21, 2017
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
U.S. Department of Education
search

1. Study Identification

Unique Protocol Identification Number
NCT00062972
Brief Title
Improving Memory in Patients With Multiple Sclerosis
Official Title
Interventions to Improve Memory in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Study terminated/withdrawn
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
U.S. Department of Education

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Cognitive Dysfunction, Treatment Interventions, Verbal memory deficits

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
donepezil
Intervention Type
Drug
Intervention Name(s)
glucose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren B. Krupp, MD
Organizational Affiliation
Department of Neurology, University Hospital Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital and Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8121
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8340793
Citation
Prosiegel M, Michael C. Neuropsychology and multiple sclerosis: diagnostic and rehabilitative approaches. J Neurol Sci. 1993 Apr;115 Suppl:S51-4. doi: 10.1016/0022-510x(93)90209-h.
Results Reference
background
PubMed Identifier
8797541
Citation
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. doi: 10.1002/ana.410400321.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
8018045
Citation
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. doi: 10.1001/archneur.1994.00540190089021.
Results Reference
background
PubMed Identifier
7608714
Citation
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. doi: 10.1136/jnnp.59.1.77.
Results Reference
background

Learn more about this trial

Improving Memory in Patients With Multiple Sclerosis

We'll reach out to this number within 24 hrs