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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Gingko biloba
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gingko biloba<br> | Drug: Gingko biloba<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in CDR factors |  | pre-dose and 2, 4, 6 hours post-dosing at baseline, days 28 and 56 | 
| 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 | 
| Number of patients with adverse events |  | up to 56 days | 
| 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 |