Clinical trial NCT02181972: Efficacy and Safety of Ginkgo Biloba in Middle-aged Cognitively Intact Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes from baseline of the cognitive test/CDR (Cognitive Drug Research) factor "Power of Attention)
timeFrame: pre-dose and 2, 4, 6 hours post-dosing at baseline and day 56
Secondary outcomes:
measure: Changes from baseline in CDR factors
timeFrame: pre-dose and 2, 4, 6 hours post-dosing at baseline, days 28 and 56
measure: Changes from baseline in Stroop Colour and Word Test
timeFrame: Baseline and day 56
measure: Changes from baseline in the Selective Reminding Test
timeFrame: Baseline and day 56
measure: Changes from baseline in the Trail Making Test (Part A and B)
timeFrame: Baseline and day 56
measure: Number of patients with adverse events
timeFrame: up to 56 days
measure: Number of patients with clinically significant changes in vital signs
timeFrame: Baseline, days 28 and 56
measure: Number of patients with abnormal changes in laboratory parameters
timeFrame: Baseline and day 56
measure: Assessment of tolerability by subject on a 4-point scale
timeFrame: Days 28 and 58
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: Days 28 and 58
Other outcomes:
Locations:
Study officials:
References: