Skip to main content
OpenTrials
Completed

NCT Number: NCT02181972

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gingko Biloba

Drug

Placebo

Drug

Primary outcomes

  1. 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

  1. Changes from baseline in CDR factors

    Time frame: pre-dose and 2, 4, 6 hours post-dosing at baseline, days 28 and 56

  2. Changes from baseline in Stroop Colour and Word Test

    Time frame: Baseline and day 56

  3. Changes from baseline in the Selective Reminding Test

    Time frame: Baseline and day 56

  4. Changes from baseline in the Trail Making Test (Part A and B)

    Time frame: Baseline and day 56

  5. Number of patients with adverse events

    Time frame: up to 56 days

  6. Number of patients with clinically significant changes in vital signs

    Time frame: Baseline, days 28 and 56

  7. Number of patients with abnormal changes in laboratory parameters

    Time frame: Baseline and day 56

  8. Assessment of tolerability by subject on a 4-point scale

    Time frame: Days 28 and 58

  9. Assessment of tolerability by investigator on a 4-point scale

    Time frame: Days 28 and 58

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2002
First posted
Jul 8, 2014
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.