NCT02181972CompletedPhase 3
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 120
- Primary Endpoint
- Changes from baseline of the cognitive test/CDR (Cognitive Drug Research) factor "Power of Attention)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Gingko biloba
Experimental
Intervention: Gingko biloba (Drug)
Outcomes
Primary Outcomes
Changes from baseline of the cognitive test/CDR (Cognitive Drug Research) factor "Power of Attention)
Time Frame: pre-dose and 2, 4, 6 hours post-dosing at baseline and day 56
Secondary Outcomes
- 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)
Investigators
Similar Trials
Completed
Phase 4
Efficacy and Safety of Ginkgo Biloba Extract in Mild Cognitive Impairment and Cerebrovascular InsufficiencyMild Cognitive ImpairmentCerebrovascular InsufficiencyNCT00446485Milsing d.o.o.90
Recruiting
Phase 3
Evaluation of the Effectiveness of Ginkgo Biloba regimen on cognitive function in patients undergoing electroconvulsive therapy: Double blind clinical trialPsychosis.Other stimulant related disordersIRCT20200516047470N1Ahvaz University of Medical Sciences80
Unknown
Not Applicable
Measurement of the Effect of Gingko Biloba Extract on Ocular and Nailfold Blood-flow in NTGNormal Tension GlaucomaNCT03761992Robert Ritch, MD, LLC.40
Recruiting
Phase 2
Gingko Biloba efficacy in treatment of drug-induced parkinsonismdrug-induced parkinsonism.Other drug-induced secondary parkinsonismG21.21IRCT20200708048060N1Tehran University of Medical Sciences102
Completed
Phase 2
Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s PhenomenonRaynaud DiseaseNCT00251238VSM Geneesmiddelen b.v.41