Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis
The purpose of this study is to see if treatment with Ginkgo improves cognitive function in people with multiple sclerosis who have cognitive problems.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Ginkgo Biloba for Cognitive Impairment in Multiple Sclerosis|
- The primary outcome will be the performance on four tests (the interference condition of the Stroop), the long delay free recall portion of the CVLT-II, the 2 second PASAT and the COWAT). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Secondary outcome measures will include adverse events, measures of self-report as well as family reports of subject's cognitive deficits and assessment of social integration. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Subjects with multiple sclerosis and documented cognitive impairment will be randomized to take the intervention or placebo.
Drug: Ginkgo biloba
120 mg orally twice a day for 12 weeks
Other Name: EGb 761
Placebo Comparator: 2
Subjects with multiple sclerosis and documented cognitive impairment will be randomized to receive the placebo.
One capsule orally twice a day for 12 weeks
Primary objective: Determine the difference between subjects treated with Ginkgo biloba (GB) and subjects treated with placebo for 12 weeks on the performance of a battery of neuropsychological tests that are frequently impaired in Multiple Sclerosis (MS): the Stroop test, the Paced Auditory Serial Addition Test (PASAT), the California Verbal Learning Test (CVLT-II), and the Controlled Oral Word Association Test (COWAT). Secondary objectives: Determine the difference between the two groups after treatment in the following outcomes: 1) incidence of treatment related side effects, 2) cognitive performance as reported by the subjects on the Perceived Deficits Questionnaire, 3) cognitive performance as reported by the subject's family members or caregivers as measured on the Multiple Sclerosis Neuropsychological Screening Questionnaire and 4) community integration as measured with the Community Integration Questionnaire.
This will be a randomized double blind placebo controlled trial of GB 120 mg twice a day for 12 weeks.
One hundred fifty-eight subjects (79 per group) will be randomly assigned to placebo or GB. Subjects will be evaluated at baseline and exit with the cognitive test battery and the self report measures detailed above.
For the primary outcome, multivariate analysis of covariance (MANCOVA) will be used to analyze the changes in all the cognitive tests simultaneously. This analysis will be followed by the analysis of covariance (ANCOVA) for each of the cognitive tests in the battery. The sample size we selected has a power of 0.80 with an alpha level of 0.05 on the overall MANCOVA and for each of the ANCOVA's after Bonferroni's correction.
The self report measures will be analyzed using ANCOVA with baseline responses as covariates.
Safety evaluations will include complete blood count and metabolic panel as well as physical exams at baseline and at exit. The physical exam will include the Expanded Disability Scale (EDSS). Telephone follow-ups will be done monthly while on treatment and one month after exiting the study to review study procedures and assess side effects. Adverse reactions will be classified using the categories and grading in the Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 3.0 and reported to the Institutional Review Board (IRB) following the institutions guidelines. A Data Safety Management Board (DSMB) will oversee the study.
|United States, Oregon|
|VA Medical Center, Portland|
|Portland, Oregon, United States, 97201|
|United States, Washington|
|VA Puget Sound Health Care System, Seattle|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Dennis N. Bourdette, MD||VA Medical Center, Portland|