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

NCT02181972 | Completed Phase 3

• 1 other identifier: 1118.2
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Gingko biloba

EXPERIMENTAL

Drug: Gingko biloba

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Gingko biloba DRUG

Gingko biloba

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Ginkgo Extract

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2002
• Primary Completion: November 1, 2002
• Last Updated: July 18, 2014

Record last verified: 2014-07