Efficacy and Safety of Ginkgo Biloba in Middle-aged Cognitively Intact Adults

Efficacy and Safety of Gingko Biloba Film-coated Tablets (2 x 60 mg Daily p.o.) in Improving Cognitive Functions and Neuropsychological Functioning of Middle-aged Cognitively Intact Adults: a Double-blind, Placebo-controlled, Parallel Group, Randomised Trial

The primary objective of this study was to assess the efficacy and safety of Gingko biloba film-coated tablets in improving cognitive function and neuropsychological functioning of middle-aged cognitively intact adults.

Inclusion Criteria:

• Male and female healthy subjects with no known clinically significant pathology as assessed by the investigator
• Mini-Mental State Examination (MMSE) score ≥ 28
• Age range: 40 to 60, inclusive
• Females must test negative for pregnancy
• Clinical laboratory tests must be within normal limits or, if out of normal range, clinically acceptable to the Investigator
• Urine drug screen for illicit drugs must be negative at screening
• Subjects must have given written informed consent in accordance with ICH-GCP (International Conference on Harmonization - Good Clinical Practice) and local laws and regulations

Exclusion Criteria:

• Any serious disorder that may interfere with his/her participation in the trial and the evaluation of the safety of the test drug
• Pre-treatment and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with the evaluation of cognitive function
• Alcohol and drug abuse according to DSM-IV (Diagnostic and Statistics Manual, Version IV)
• Individuals drinking more than 6 cups of coffee or tea/day
• Individuals smoking more than 10 cigarettes/day
• Subjects who in the opinion of the investigator are heavy users of other tobacco or nicotine products
• Subjects currently taking a cognition enhancing substance, including any Ginkgo or ginseng product
• Any subject regularly taking a medication who might stop doing so at some time during the active dosing phase, if the medication is deemed by the investigator to influence the outcome of the trial
• Female subjects of child-bearing age who are not using adequate means of birth control
• Pregnancy and/or lactation
• Any subject who, according to the Investigator, is unable to perform the CDR cognitive tests or the neuropsychological tests in a satisfactory and consistent manner
• Relevant allergy or known hypersensitivity to the investigational product or its excipients
• Individuals under anticoagulant treatment
• Individuals with a current disorder likely to modify computerised cognitive testing
• Individuals having a history of cancer (any type, excluding surgically removed and treated basal cell carcinoma)
• Clinically significant and not treated thyroid disease
• Participation in another clinical trial within the last 3 months prior to the start of the study and concurrent participation in another clinical trial