Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00841321
Recruitment Status : Completed
First Posted : February 11, 2009
Results First Posted : May 5, 2014
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Cognitive Ability, General Drug: Ginkgo biloba Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ginkgo Biloba for Cognitive Impairment in Multiple Sclerosis
Study Start Date : January 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 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: Arm 2
Subjects with multiple sclerosis and documented cognitive impairment will be randomized to receive the placebo.
Drug: Placebo
One capsule orally twice a day for 12 weeks




Primary Outcome Measures :
  1. Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test. [ Time Frame: 12 weeks ]

    Performance at exit adjusted for baseline performance on 4 neuropsychological tests:

    STROOP(Victoria version):Tests attention&executive function. Outcome is the interference condition condition; time needed to name the colors in which words (which are names of colors) are printed. Words and colors are mismatched.

    CaliforniaVerbalLearningTest- II: Tests verbal/learning/memory. Outcome number of words (shopping list) remembered after 20 min delay with no cues.

    PacedAuditorySerialAdditionTest:Tests working memory/sustained attention. Outcome is the number of correct responses to recording giving numbers every 2 sec. Last 2 numbers must be added together before the next number.

    ControlledOralWordAssociationTest:Tests letter fluency. Outcome number of words produced in one minute for each of 3 letters.

    Measures reported as Z-scores based on the available population norms for each test; range -infinite +infinite; 0 average; -1=1std below average; +1=1std above average.



Secondary Outcome Measures :
  1. Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration. [ Time Frame: 12 weeks ]

    The Perceived Deficits Questionnaire (PDQ), a standardized questionnaire in which the subject reports on his or her cognitive function; Measure total score Range (0 best - 80 worse) Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ), in which the family member who was most aware of the participant's cognitive deficits reports on the subject's cognitive deficits; measure total score range (0 best - 60 worse) 'and the Community Integration Questionnaire (CIQ) in which the subject reports his or her degree of social integration; range (0 worst - 32 best); measure total score.

    Sub-scales for these 3 measures were not used for outcome measures only total scores.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of multiple sclerosis by McDonald's criteria
  • Age 18 to 65 years, inclusive
  • A score minus one standard deviation below the mean on one or more of the following tests: PASAT, COWAT, CVLT-II, Stroop
  • EDSS 0 - 7.5, inclusive
  • No Ginkgo biloba in preceding 30 days
  • Native English speaker

Exclusion Criteria:

  • Current substance abuse disorder, psychosis, or significant depression (score on the Beck Depression Inventory II (BDI -II) greater than 28
  • Any significant uncontrolled medical problem including diabetes requiring insulin
  • Relapse of multiple sclerosis within the 30 days before screening
  • Abnormalities of coagulation or current use of anticoagulants or antiplatelet agents
  • Elective surgery planned for the study period or the following four weeks
  • Epilepsy or history of seizures
  • Use of nifedipine, nicardipine, Saint John's Wort, papaverine, mono amine oxidase inhibitors
  • Pregnancy or women not using a reliable form of contraception
  • Corrected binocular visual acuity worse than 20/50 or more than one error on binocular color vision testing with the Ishihara Color Plates or sustained nystagmus or diplopia on primary gaze
  • Inability to complete the neuropsychological test battery at the screening visit
  • History of alcohol abuse or illicit drug use in the prior six months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841321


Locations
Layout table for location information
United States, Oregon
Portland VA Medical Center, Portland, OR
Portland, Oregon, United States, 97239
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
Layout table for investigator information
Principal Investigator: Dennis N. Bourdette, MD Portland VA Medical Center, Portland, OR
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00841321    
Other Study ID Numbers: B4368-R
First Posted: February 11, 2009    Key Record Dates
Results First Posted: May 5, 2014
Last Update Posted: June 6, 2014
Last Verified: May 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Ginkgo biloba
Multiple Sclerosis
Cognition
Neuropsychological Tests
Neurobehavioral Manifestations
Quality of life
Randomized Controlled Trials
Placebos
Double-Blind Method
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases