Phase 2
Completed N=120
Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis
Multiple Sclerosis · Cognitive Ability, General
Source: ClinicalTrials.gov NCT00841321 ↗
Enrolled (actual)
120
Serious AEs
1.7%
Results posted
May 2014
Primary outcomePrimary: 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. — -1.4; -1.3; -1.2; -1.0 z-scores — p=.1
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-1.4; -1.3; -1.2; -1.0; -0.9; -0.8 | .1 |
| SECONDARY Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration. |
37.2; 31.7; 38.2; 33.4; 25.2; 24.5 | 0.4 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00841321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.