Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis
Condition: Multiple Sclerosis; Cognitive Ability, General
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if treatment with Ginkgo improves cognitive function in
      people with multiple sclerosis who have cognitive problems.
    

Detailed description: 
      Objectives:

      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.

      Research plan:

      This will be a randomized double blind placebo controlled trial of GB 120 mg twice a day for
      12 weeks.

      Methods:

      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.
    

Intervention name(s): Ginkgo biloba; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 120 mg orally twice a day for 12 weeks; One capsule orally twice a day for 12 weeks
Other intervention name(s): EGb 761
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ginkgo biloba; Multiple Sclerosis; Cognition; Neuropsychological Tests; Neurobehavioral Manifestations; Quality of life; Randomized Controlled Trials; Placebos; Double-Blind Method