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

Launched by BOEHRINGER INGELHEIM · Jul 7, 2014

Keywords

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Gender

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Eligibility criteria

• 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