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Improving Memory in Patients with Multiple Sclerosis



Improving Memory in Patients with Multiple Sclerosis

For Condition: Multiple Sclerosis
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , Department of Education
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/56 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 60

Location and Contact Information:

Overall Study Official:
LaurenKrupp,  Principal Investigator,  Department of Neurology, University Hospital Medical Center

University Hospital and Medical Center *Recruiting*
Stony Brook,  New York,  11794-8121
United States
Recruiting Patricia  Melville 631-444-8164


Additional Information:
Study ID Numbers:  1R01 HD38107-01; 
Study Start Date: September 1999
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062972

Other Multiple Sclerosis Studies:
1. Antibiotic treatment trial directed against Chlamydia pneumonia in multiple sclerosis

2. Assessment of Patients with Multiple Sclerosis (MS)

3. Safety and Efficacy study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis

4. Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW)

5. Combination Therapy with Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis

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