HealthyPhase 3NCT02181972
Efficacy and Safety of Ginkgo Biloba in Middle-aged Cognitively Intact Adults
A Phase 3 study testing Gingko biloba in people with Healthy, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gingko biloba
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Nov 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
About this study
Official 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
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
- Being tested
- Gingko biloba, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingko bilobaDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Gingko biloba | Experimental | Not described Receives: Drug: Gingko biloba |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline of the cognitive test/CDR (Cognitive Drug Research) factor "Power of Attention)
Measured: pre-dose and 2, 4, 6 hours post-dosing at baseline and day 56
Secondary outcomes (9)
Changes from baseline in CDR factors
Measured: pre-dose and 2, 4, 6 hours post-dosing at baseline, days 28 and 56
Changes from baseline in Stroop Colour and Word Test
Measured: Baseline and day 56
Changes from baseline in the Selective Reminding Test
Measured: Baseline and day 56
Changes from baseline in the Trail Making Test (Part A and B)
Measured: Baseline and day 56
Number of patients with adverse events
Measured: up to 56 days
Number of patients with clinically significant changes in vital signs
Measured: Baseline, days 28 and 56
Number of patients with abnormal changes in laboratory parameters
Measured: Baseline and day 56
Assessment of tolerability by subject on a 4-point scale
Measured: Days 28 and 58
Assessment of tolerability by investigator on a 4-point scale
Measured: Days 28 and 58
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 2002
- Primary completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181972
- Sponsor's protocol ID
- 1118.2
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02181972
- Acronym / sponsor ID
- 1118.2
- Conditions
- Healthy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Nov 2002 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gingko biloba | Experimental | Drug: Gingko biloba |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingko biloba | Drug | Gingko biloba |
| Placebo | Drug | Placebo |
Primary outcome
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
9 secondary outcomes
Changes from baseline in CDR factors
Time frame: pre-dose and 2, 4, 6 hours post-dosing at baseline, days 28 and 56
Changes from baseline in Stroop Colour and Word Test
Time frame: Baseline and day 56
Changes from baseline in the Selective Reminding Test
Time frame: Baseline and day 56
Changes from baseline in the Trail Making Test (Part A and B)
Time frame: Baseline and day 56
Number of patients with adverse events
Time frame: up to 56 days
Number of patients with clinically significant changes in vital signs
Time frame: Baseline, days 28 and 56
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline and day 56
Assessment of tolerability by subject on a 4-point scale
Time frame: Days 28 and 58
Assessment of tolerability by investigator on a 4-point scale
Time frame: Days 28 and 58
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gingko biloba in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.