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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development

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