Age-Related Memory DisordersPhase 3NCT01160692
A Study to Evaluate The Effects Of a Multivitamin/Mineral With Ginko In Subjects With Age Associated Memory Impairment
A Phase 3 study testing Multivitamin/Multimineral/Ginkgo (BAY 81-2775) in people with Age-Related Memory Disorders, run by Bayer at 1 site in United Kingdom.
Trial summary
A Study to evaluate the cognitive effects and tolerance of a Multi-Vitamin/Mineral Preperation containing Gingko in elderly subjects with age associated memory impairment. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Memory Disorders
- What is being tested?
- Multivitamin/Multimineral/Ginkgo (BAY 81-2775)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2006to Jul 2008
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is generally healthy (includes subjects presenting with mild chronic diseases where the disease and/or the pharmacological treatment does not result in psychomotor impairment or improvement).
- Subject is of either gender, and 60+ years of age, inclusive.
- Subject demonstrates Age Associated Memory Impairment after completion of the CDR test battery and comparison to normative data.
- Female subject who is post-menopausal.
- Subject is able to understand the study instructions and has given written informed consent prior to study participation.
- Subject admitted to this study is oriented to person, place and time and has the ability to communicate with the study staff.
- Subject is, in the opinion of the study staff, motivated to participate and complete the study as instructed.
- Subject is willing to be attend visits in a well-rested state.
Who cannot join
- Subject has participated in an interventional study within the one month prior to screening.
- Intake within three months prior to screening, or intended intake during the study, of one of the following: Ginkgo biloba, St John's Wort, Ginseng, Gotu Kola (Indian Pennywort), or daily doses of vitamin E (-tocopherol) above 30 mg, folic acid above 400 g, vitamins B-1 (thiamine), B-2 (riboflavin), B-6 (pyridoxine) above 2 mg, or other cognition enhancers.
- Subject has a history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
- Subject has a history of Alzheimers disease, dementia, mental retardation, Morbus Parkinson, or any other mental disorders.
- Subject has not been diagnosed with AAMI after completion of the CDR test battery and comparison to normative data.
- Subject has a history of any bleeding/coagulation disorder (e.g., haemophilia, Protein C or S deficiency).
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- Subject is taking/being treated with a concomitant medication which may affect/inhibit blood coagulation (e.g., warfarin, aspirin, heparin).
- Subject has history of relevant vascular disorders (e.g., carotid stenosis, stroke, PRIND, coronary artery disease, peripheral vascular disease, thrombosis).
- Subject has Body Mass Index (BMI) above 40 kg/m2 (severely obese).
- Subject smokes more than 15 cigarettes, or equivalent daily.
- Subject has moderate-to-severe hepatic impairment.
- Subject has history of alcohol or drug abuse.
- Subject has known allergies or intolerance to any ingredients in the study preparations.
- Subject is intending to undergo surgery during or immediately upon completion (within two weeks) of study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Parallel Group, Double Blind Study to Evaluate the Cognitive Effects and Tolerance of a Multi-Vitamin/Mineral Preparation Containing Gingko in Elderly Subjects With Age Associated Memory Impairment
A Study to evaluate the cognitive effects and tolerance of a Multi-Vitamin/Mineral Preperation containing Gingko in elderly subjects with age associated memory impairment.
- Conditions
- Age-Related Memory Disorders
- Being tested
- Multivitamin/Multimineral/Ginkgo (BAY 81-2775), Placebo
- Keywords
- Memory, Cognitive Function, Elderly, Gingko, Age Associated Memory Impairment (AAMI)
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamin/Multimineral/Ginkgo (BAY 81-2775)Dietary supplement
Multivitamin/Multimineral/Ginkgo (BAY 81-2775), daily oral intake of film coated tablets for 3 months
PlaceboOther
Daily oral intake of matching placebo tablets for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Dietary Supplement: Multivitamin/Multimineral/Ginkgo (BAY 81-2775) |
| Arm 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system.
Measured: From baseline up to 12 weeks
Secondary outcomes (3)
The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires.
Measured: From baseline up to 12 weeks
Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko.
Measured: From baseline up to 14 weeks
The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires.
Measured: From baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startFeb 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Memory DisordersStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160692
- Sponsor's protocol ID
- 11954
- Status last verified
- Jul 2010
- First submitted
- 8 Oct 2009
- Last updated
- 2 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Parallel Group, Double Blind Study to Evaluate the Cognitive Effects and Tolerance of a Multi-Vitamin/Mineral Preparation Containing Gingko in Elderly Subjects With Age Associated Memory Impairment
- ClinicalTrials.gov ID
- NCT01160692
- Acronym / sponsor ID
- 11954
- Conditions
- Age-Related Memory Disorders
- Keywords
- Memory, Cognitive Function, Elderly, Gingko, Age Associated Memory Impairment (AAMI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 Jul 2010 (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.
A Study to evaluate the cognitive effects and tolerance of a Multi-Vitamin/Mineral Preperation containing Gingko in elderly subjects with age associated memory impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Dietary Supplement: Multivitamin/Multimineral/Ginkgo (BAY 81-2775) |
| Arm 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is generally healthy (includes subjects presenting with mild chronic diseases where the disease and/or the pharmacological treatment does not result in psychomotor impairment or improvement).
- Subject is of either gender, and 60+ years of age, inclusive.
- Subject demonstrates Age Associated Memory Impairment after completion of the CDR test battery and comparison to normative data.
- Female subject who is post-menopausal.
- Subject is able to understand the study instructions and has given written informed consent prior to study participation.
Key exclusion criteria (14 listed)
- Subject has participated in an interventional study within the one month prior to screening.
- Intake within three months prior to screening, or intended intake during the study, of one of the following: Ginkgo biloba, St John's Wort, Ginseng, Gotu Kola (Indian Pennywort), or daily doses of vitamin E (-tocopherol) above 30 mg, folic acid above 400 g, vitamins B-1 (thiamine), B-2 (riboflavin), B-6 (pyridoxine) above 2 mg, or other cognition enhancers.
- Subject has a history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
- Subject has a history of Alzheimers disease, dementia, mental retardation, Morbus Parkinson, or any other mental disorders.
- Subject has not been diagnosed with AAMI after completion of the CDR test battery and comparison to normative data.
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 |
|---|---|---|
| Multivitamin/Multimineral/Ginkgo (BAY 81-2775)Multivitamin/Multimineral/Ginkgo (BAY 81-2775), daily oral intake of film coated tablets for 3 months | Dietary supplement | Arm 1 |
| PlaceboDaily oral intake of matching placebo tablets for 3 months | Other | Arm 2 |
Primary outcome
The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system.
Time frame: From baseline up to 12 weeks
3 secondary outcomes
The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires.
Time frame: From baseline up to 12 weeks
Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko.
Time frame: From baseline up to 14 weeks
The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires.
Time frame: From baseline up to 12 weeks
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 2 Aug 2010.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multivitamin/Multimineral/Ginkgo (BAY 81-2775) in people with Age-Related Memory Disorders, run by Bayer at 1 site in United Kingdom.
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 8 inclusion and 14 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 2 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system. (time frame: From baseline up to 12 weeks). 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 2 Aug 2010.