Healthy
Conditions
Brief summary
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.
Interventions
DRUGGingko biloba
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline of the cognitive test/CDR (Cognitive Drug Research) factor Power of Attention) | pre-dose and 2, 4, 6 hours post-dosing at baseline and day 56 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with clinically significant changes in vital signs | Baseline, days 28 and 56 |
| Number of patients with abnormal changes in laboratory parameters | Baseline and day 56 |
| Assessment of tolerability by subject on a 4-point scale | Days 28 and 58 |
| Assessment of tolerability by investigator on a 4-point scale | Days 28 and 58 |
| Number of patients with adverse events | up to 56 days |
| Changes from baseline in Stroop Colour and Word Test | Baseline and day 56 |
| Changes from baseline in the Selective Reminding Test | Baseline and day 56 |
| Changes from baseline in the Trail Making Test (Part A and B) | Baseline and day 56 |
| Changes from baseline in CDR factors | pre-dose and 2, 4, 6 hours post-dosing at baseline, days 28 and 56 |
Outcome results
None listed