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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Gingko biloba

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Gingko biloba	Drug: Gingko biloba

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): November 1, 2002

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 18, 2014
• Last Update Submitted That Met QC Criteria: July 17, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1118.2