DementiaPhase 3NCT00010920
Preventing Cognitive Decline With Alternative Therapies
A Phase 3 study testing Ginkgo Biloba Extract in people with Dementia and Memory Disorders, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
Preventing dementia is an important goal for our aging population. This proposal is an initial 42 months study of the effect of standardized ginkgo biloba extract (GBE) on preventing or delaying cognitive decline in people age 85 years or older (the oldest old). Read more about this study
- Who is it for?
- Ages 85 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Memory Disorders
- What is being tested?
- Ginkgo Biloba Extract
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Dec 2004
- 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 85 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Can identify a collateral informant who has frequent contact with the subject
- No memory complaints compared to others of same age group and has not sought attention for concerns about memory or cognition
- Normal memory function defined by an education-adjusted score on the Logical Memory Subscale of the Wechsler Memory Scale-Revised
- Mini-Mental State Examination Score >23
- Clinical Dementia Rating (CDR) of zero
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health Sciences University/Neurology
Portland, Oregon, 97201
About this study
Preventing dementia is an important goal for our aging population. This proposal is an initial 42 months study of the effect of standardized ginkgo biloba extract (GBE) on preventing or delaying cognitive decline in people age 85 years or older (the oldest old). The study focuses on the oldest old who present a distinct advantage for primary prevention studies because of their particularly high risk for developing mild cognitive impairment (MCI), a precursor to dementia. Because this is a population that has previously been out of the mainstream for use of alternative medicine, the safety of GBE in this age group will also be tested in this study. The study is randomized, placebo controlled and double blind. Approximately 200 elderly cognitively healthy subjects will be enrolled and followed for detection of conversion to MCI. This pilot study is viewed as a necessary first step in order to demonstrate that GBE, an alternative or complementary therapy, has a disease modifying effect on the brain, distinct from a symptomatic effect. The study will test the feasibility of the randomized start design, a trial design proposed as a method for discerning brain- or disease- modifying from symptomatic effects. The magnitude of biological effect of the treatments will also be assessed with volumetric quantitative MRI, a complementary means of confirming whether there is a brain modifying effect (measured as a decrease in brain volume loss with treatment). Peripheral markers of oxidation status will measure possible anti-oxidant effects of GBE.
Read the detailed description
See brief summary
- Conditions
- Dementia, Memory Disorders
- Being tested
- Ginkgo Biloba Extract
- Medical subject headings
- Dementia, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo Biloba ExtractDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2001 (estimated)
- Study startSep 1999
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Dr. Jeffrey Kaye, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010920
- Sponsor's protocol ID
- P50AT000066-01P2
- Other IDs
- P50AT000066-01
- Status last verified
- Aug 2006
- First submitted
- 2 Feb 2001
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Cognitive Decline With Alternative Therapies
- ClinicalTrials.gov ID
- NCT00010920
- Acronym / sponsor ID
- P50AT000066-01P2
- Conditions
- Dementia, Memory Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 1999
- Study completion
- Dec 2004
- First posted
- 5 Feb 2001 (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.
Preventing dementia is an important goal for our aging population. This proposal is an initial 42 months study of the effect of standardized ginkgo biloba extract (GBE) on preventing or delaying cognitive decline in people age 85 years or older (the oldest old). The study focuses on the oldest old who present a distinct advantage for primary prevention studies because of their particularly high risk for developing mild cognitive impairment (MCI), a precursor to dementia. Because this is a population that has previously been out of the mainstream for use of alternative medicine, the safety of GBE in this age group will also be tested in this study. The study is randomized, placebo controlled and double blind. Approximately 200 elderly cognitively healthy subjects will be enrolled and followed for detection of conversion to MCI. This pilot study is viewed as a necessary first step in order to demonstrate that GBE, an alternative or complementary therapy, has a disease modifying effect on the brain, distinct from a symptomatic effect. The study will test the feasibility of the randomized start design, a trial design proposed as a method for discerning brain- or disease- modifying from symptomatic effects. The magnitude of biological effect of the treatments will also be assessed with volumetric quantitative MRI, a complementary means of confirming whether there is a brain modifying effect (measured as a decrease in brain volume loss with treatment). Peripheral markers of oxidation status will measure possible anti-oxidant effects of GBE.
Detailed description
See brief summary
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 85 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Can identify a collateral informant who has frequent contact with the subject
- No memory complaints compared to others of same age group and has not sought attention for concerns about memory or cognition
- Normal memory function defined by an education-adjusted score on the Logical Memory Subscale of the Wechsler Memory Scale-Revised
- Mini-Mental State Examination Score >23
- Clinical Dementia Rating (CDR) of zero
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ginkgo Biloba Extract | Drug | – |
Primary outcome
Not reported in the source record.
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 Aug 2006.
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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.
Dr. Jeffrey Kaye principal investigator
Oregon Health and Science University
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 Ginkgo Biloba Extract in people with Dementia and Memory Disorders, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 5 inclusion and 0 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 Aug 2006. 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 States. 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. 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.
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 Aug 2006.