Improving Memory in Patients With Multiple Sclerosis

This study is currently recruiting participants.

Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), December 2003

First Received: June 18, 2003 Last Updated: June 23, 2005 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:	Department of Education
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00062972

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: donepezil Drug: glucose	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Interventions to Improve Memory in Patients With Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Memory Multiple Sclerosis

Drug Information available for: E 2020 Donepezil

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:	60
Study Start Date:	September 1999
Estimated Study Completion Date:	August 2002

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.

Eligibility

Ages Eligible for Study:	18 Years to 56 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062972

Contacts

Contact: Patricia Melville, RN

631-444-8164

Pmelvill@neuro.som.sunysb.edu

Locations

United States, New York
University Hospital and Medical Center	Recruiting
Stony Brook, New York, United States, 11794-8121
Contact: Patricia Melville, RN 631-444-8164 Pmelvill@neuro.som.sunysb.edu

Sponsors and Collaborators

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

Department of Education

Investigators

Principal Investigator:

Lauren B. Krupp, MD

Department of Neurology, University Hospital Medical Center

More Information

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.

Study ID Numbers:	1R01 HD38107-01
Study First Received:	June 18, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00062972 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Multiple Sclerosis
Cognitive Dysfunction
Treatment Interventions
Verbal memory deficits

Additional relevant MeSH terms:

Nootropic Agents
Neurotransmitter Agents
Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Sclerosis
Enzyme Inhibitors

Cholinergic Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Donepezil
Demyelinating Autoimmune Diseases, CNS
Central Nervous System Agents
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 27, 2009