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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Healthy

Treatments

Drug: Placebo

Drug: Gingko biloba

Study type

Interventional

Funder types

Industry

Identifiers

NCT02181972

1118.2

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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