DementiaPhase 3NCT00010803
Ginkgo Biloba Prevention Trial in Older Individuals
A Phase 3 study testing Ginkgo biloba in people with Dementia and Alzheimer's Disease, run by National Center for Complementary and Integrative Health (NCCIH) at 5 sites in United States.
Trial summary
This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and functional disability, reducing incidence of cardiovascular disease, and decreasing total mortality. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer's Disease
- What is being tested?
- Ginkgo biloba
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,069 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2000to Jul 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Non-demented participants
- Willing to participate in a seven-year follow-up trial of Ginkgo Biloba
- English is their usual language
- Willing informant who has frequent contact with the participant
Who cannot join
- Currently on anticoagulant therapy
- Cancer diagnosed and treated within the past two years (except for skin cancer)
- Participant with class III - IV congestive heart failure
- Currently being treated with psychopharmacological drugs for depression
- Hospitalized for depression within the last year
- Taking Aricept (or similar agents) for cognitive problems or dementia
Show all 10Show fewer
- Baseline blood creatinine >2
- Baseline SGGT is a marker of liver function (3 x normal>or=90 IU)
- Baseline hematocrit<30
- Baseline white blood count>or=15,000
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University of Pittsburgh/University of Virginia
Charlottesville, Virginia, 22908
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California, Davis
Sacramento, California, 95817
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1063
About this study
This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and functional disability, reducing incidence of cardiovascular disease, and decreasing total mortality.
Read the detailed description
Participants will be studied in a randomized trial of 240 mg of Ginkgo biloba as compared to placebo in healthy men and women, at least 75 years old. The trial will last approximately 8 years. The intervention will be considered unsuccessful in those participants who succumb to dementia, including Alzheimer's Disease and vascular dementia. There are four clinical centers: Pittsburgh, PA; Hagerstown, MD; Winston-Salem, NC; and Sacramento, CA; and a Coordinating Center at the University of Washington, Seattle. There will be a clinic visit every 6 months to determine morbidity, mortality and change in cognition that will include repeat of ADAS, CDR, and 10 battery neuropsychological evaluation and informant interview. The primary endpoint is dementia, specifically Alzheimer's disease, secondary endpoint will include the incidence of vascular disease, changes in cognitive function scores over time, total mortality and changes in functional status. The diagnosis of dementia will be based on neuropsychological testing, neurological exam, MRI, functional measurements, and review by a central adjudication committee and classified by DSM IV, NINCDS criteria and ADRTC criteria for vascular disease.
- Conditions
- Dementia, Alzheimer's Disease
- Being tested
- Ginkgo biloba, Placebo
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo bilobaDrug
Also called EGb761
120mg twice a day
PlaceboDrug
Also called Identical appearance as Ginkgo biloba pill
One pill twice daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 1 pill twice a day Receives: Drug: Placebo |
| Ginkgo biloba | Active comparator | Ginkgo biloba EGb761 120 mg twice daily Receives: Drug: Ginkgo biloba |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Incident Dementia
All cause dementia based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. A full neuropsychological battery was administered annually, or at 6 month visit if there was a diagnosis of dementia or initiation of medication for dementia by private physician, or change in Modified Mini Mental State Exam (3MSE), Clinical Dementia Rating (CDR), or Alzheimer Disease Assessment Scale (ADAS-Cog). Decline on tests scores based on an algorithm resulted in a neurological exam and brain imaging. These data were used in the adjudication process.
Measured: Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up
Secondary outcomes (2)
Number of Participants With the Indicated Cardiovascular Disease or Mortality
Myocardial infarction (MI), angina, stroke (CVA), transient ischemic attack (TIA), combined coronary heart disease (CHD) (MI/angina), combined cerebrovascular (CVA/TIA), peripheral vascular disease, and mortality
Measured: 6 months
Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.
Rate of annual change by cognitive domain in standardized Z-score scale. Higher Z-scores indicate worse performance. Best score = -2.0 Z-score change per year (improvement); worse score = 2.0 Z-score change per year (decline).
Measured: 6 months/annually
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 startOct 2000
- Primary completionApr 2008
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- 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
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,069 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Steven T. DeKosky, M.D., Principal investigator, University of Pittsburgh, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010803
- Sponsor's protocol ID
- U01 AT000162-01M
- Other IDs
- U01AT000162-01
- Status last verified
- Mar 2013
- First submitted
- 2 Feb 2001
- Last updated
- 14 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fitzpatrick AL, Fried LP, Williamson J, Crowley P, Posey D, Kwong L, Bonk J, Moyer R, Chabot J, Kidoguchi L, Furberg CD, DeKosky ST; GEM Study Investigators. Recruitment of the elderly into a pharmacologic prevention trial: the Ginkgo Evaluation of Memory Study experience. Contemp Clin Trials. 2006 Dec;27(6):541-53. doi: 10.1016/j.cct.2006.06.007. Epub 2006 Jul 4.
PubMed 16949348DeKosky ST, Fitzpatrick A, Ives DG, Saxton J, Williamson J, Lopez OL, Burke G, Fried L, Kuller LH, Robbins J, Tracy R, Woolard N, Dunn L, Kronmal R, Nahin R, Furberg C; GEMS Investigators. The Ginkgo Evaluation of Memory (GEM) study: design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia. Contemp Clin Trials. 2006 Jun;27(3):238-53. doi: 10.1016/j.cct.2006.02.007. Epub 2006 Apr 19.
PubMed 16627007Fitzpatrick AL, Buchanan CK, Nahin RL, Dekosky ST, Atkinson HH, Carlson MC, Williamson JD; Ginkgo Evaluation of Memory (GEM) Study Investigators. Associations of gait speed and other measures of physical function with cognition in a healthy cohort of elderly persons. J Gerontol A Biol Sci Med Sci. 2007 Nov;62(11):1244-51. doi: 10.1093/gerona/62.11.1244.
PubMed 18000144Nahin RL, Fitzpatrick AL, Williamson JD, Burke GL, Dekosky ST, Furberg C; GEM Study Investigators. Use of herbal medicine and other dietary supplements in community-dwelling older people: Baseline data from the ginkgo evaluation of memory study. J Am Geriatr Soc. 2006 Nov;54(11):1725-35. doi: 10.1111/j.1532-5415.2006.00942.x.
PubMed 17087700Rosano C, Aizenstein HJ, Cochran JL, Saxton JA, De Kosky ST, Newman AB, Kuller LH, Lopez OL, Carter CS. Event-related functional magnetic resonance imaging investigation of executive control in very old individuals with mild cognitive impairment. Biol Psychiatry. 2005 Apr 1;57(7):761-7. doi: 10.1016/j.biopsych.2004.12.031.
PubMed 15820233Rosano C, Aizenstein H, Cochran J, Saxton J, De Kosky S, Newman AB, Kuller LH, Lopez OL, Carter CS. Functional neuroimaging indicators of successful executive control in the oldest old. Neuroimage. 2005 Dec;28(4):881-9. doi: 10.1016/j.neuroimage.2005.05.059. Epub 2005 Oct 12.
PubMed 16226041Williamson JD, Vellas B, Furberg C, Nahin R, Dekosky ST. Comparison of the design differences between the Ginkgo Evaluation of Memory study and the GuidAge study. J Nutr Health Aging. 2008 Jan;12(1):73S-9S. doi: 10.1007/BF02982591.
PubMed 18165850Saxton J, Snitz BE, Lopez OL, Ives DG, Dunn LO, Fitzpatrick A, Carlson MC, Dekosky ST; GEM Study Investigators. Functional and cognitive criteria produce different rates of mild cognitive impairment and conversion to dementia. J Neurol Neurosurg Psychiatry. 2009 Jul;80(7):737-43. doi: 10.1136/jnnp.2008.160705. Epub 2009 Mar 11.
PubMed 19279031Snitz BE, Saxton J, Lopez OL, Ives DG, Dunn LO, Rapp SR, Carlson MC, Fitzpatrick AL, Dekosky ST; GEM study Investigators. Identifying mild cognitive impairment at baseline in the Ginkgo Evaluation of Memory (GEM) study. Aging Ment Health. 2009 Mar;13(2):171-82. doi: 10.1080/13607860802380656.
PubMed 19347684DeKosky ST, Williamson JD, Fitzpatrick AL, Kronmal RA, Ives DG, Saxton JA, Lopez OL, Burke G, Carlson MC, Fried LP, Kuller LH, Robbins JA, Tracy RP, Woolard NF, Dunn L, Snitz BE, Nahin RL, Furberg CD; Ginkgo Evaluation of Memory (GEM) Study Investigators. Ginkgo biloba for prevention of dementia: a randomized controlled trial. JAMA. 2008 Nov 19;300(19):2253-62. doi: 10.1001/jama.2008.683.
PubMed 19017911Kuller LH, Ives DG, Fitzpatrick AL, Carlson MC, Mercado C, Lopez OL, Burke GL, Furberg CD, DeKosky ST; Ginkgo Evaluation of Memory Study Investigators. Does Ginkgo biloba reduce the risk of cardiovascular events? Circ Cardiovasc Qual Outcomes. 2010 Jan;3(1):41-7. doi: 10.1161/CIRCOUTCOMES.109.871640. Epub 2009 Nov 24.
PubMed 20123670Snitz BE, O'Meara ES, Carlson MC, Arnold A, Ives DG, Rapp SR, Saxton J, Lopez OL, Dunn LO, Sink K, DeKosky ST for the Ginkgo Evaluation of Memory Study investigators. Ginkgo biloba in preventing cognitive decline in older adults: A randomized trial. Journal of the American Medical Aassociation, 2009, in press.
Snitz BE, O'Meara ES, Carlson MC, Arnold AM, Ives DG, Rapp SR, Saxton J, Lopez OL, Dunn LO, Sink KM, DeKosky ST; Ginkgo Evaluation of Memory (GEM) Study Investigators. Ginkgo biloba for preventing cognitive decline in older adults: a randomized trial. JAMA. 2009 Dec 23;302(24):2663-70. doi: 10.1001/jama.2009.1913.
PubMed 20040554
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ginkgo Biloba Prevention Trial in Older Individuals
- ClinicalTrials.gov ID
- NCT00010803
- Acronym / sponsor ID
- U01 AT000162-01M
- Conditions
- Dementia, Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,069 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2000
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Feb 2001 (estimated)
- Results
- Posted 16 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and functional disability, reducing incidence of cardiovascular disease, and decreasing total mortality.
Detailed description
Participants will be studied in a randomized trial of 240 mg of Ginkgo biloba as compared to placebo in healthy men and women, at least 75 years old. The trial will last approximately 8 years. The intervention will be considered unsuccessful in those participants who succumb to dementia, including Alzheimer's Disease and vascular dementia. There are four clinical centers: Pittsburgh, PA; Hagerstown, MD; Winston-Salem, NC; and Sacramento, CA; and a Coordinating Center at the University of Washington, Seattle. There will be a clinic visit every 6 months to determine morbidity, mortality and change in cognition that will include repeat of ADAS, CDR, and 10 battery neuropsychological evaluation and informant interview. The primary endpoint is dementia, specifically Alzheimer's disease, secondary endpoint will include the incidence of vascular disease, changes in cognitive function scores over time, total mortality and changes in functional status. The diagnosis of dementia will be based on neuropsychological testing, neurological exam, MRI, functional measurements, and review by a central adjudication committee and classified by DSM IV, NINCDS criteria and ADRTC criteria for vascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1 pill twice a day |
| Ginkgo biloba | Active comparator | Drug: Ginkgo bilobaGinkgo biloba EGb761 120 mg twice daily |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Non-demented participants
- Willing to participate in a seven-year follow-up trial of Ginkgo Biloba
- English is their usual language
- Willing informant who has frequent contact with the participant
Key exclusion criteria (10 listed)
- Currently on anticoagulant therapy
- Cancer diagnosed and treated within the past two years (except for skin cancer)
- Participant with class III - IV congestive heart failure
- Currently being treated with psychopharmacological drugs for depression
- Hospitalized for depression within the last year
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 bilobaAlso: EGb761120mg twice a day | Drug | Ginkgo biloba |
| PlaceboAlso: Identical appearance as Ginkgo biloba pillOne pill twice daily | Drug | Placebo |
Primary outcome
Number of Participants With Incident Dementia
Time frame: Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up
All cause dementia based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. A full neuropsychological battery was administered annually, or at 6 month visit if there was a diagnosis of dementia or initiation of medication for dementia by private physician, or change in Modified Mini Mental State Exam (3MSE), Clinical Dementia Rating (CDR), or Alzheimer Disease Assessment Scale (ADAS-Cog). Decline on tests scores based on an algorithm resulted in a neurological exam and brain imaging. These data were used in the adjudication process.
2 secondary outcomes
Number of Participants With the Indicated Cardiovascular Disease or Mortality
Time frame: 6 months
Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.
Time frame: 6 months/annually
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16949348Fitzpatrick AL, Fried LP, Williamson J, Crowley P, Posey D, Kwong L, Bonk J, Moyer R, Chabot J, Kidoguchi L, Furberg CD, DeKosky ST; GEM Study Investigators. Recruitment of the elderly into a pharmacologic prevention trial: the Ginkgo Evaluation of Memory Study experience. Contemp Clin Trials. 2006 Dec;27(6):541-53. doi: 10.1016/j.cct.2006.06.007. Epub 2006 Jul 4.
- Background: PubMed 16627007DeKosky ST, Fitzpatrick A, Ives DG, Saxton J, Williamson J, Lopez OL, Burke G, Fried L, Kuller LH, Robbins J, Tracy R, Woolard N, Dunn L, Kronmal R, Nahin R, Furberg C; GEMS Investigators. The Ginkgo Evaluation of Memory (GEM) study: design and baseline data of a randomized trial of Ginkgo biloba extract in prevention of dementia. Contemp Clin Trials. 2006 Jun;27(3):238-53. doi: 10.1016/j.cct.2006.02.007. Epub 2006 Apr 19.
- Background: PubMed 18000144Fitzpatrick AL, Buchanan CK, Nahin RL, Dekosky ST, Atkinson HH, Carlson MC, Williamson JD; Ginkgo Evaluation of Memory (GEM) Study Investigators. Associations of gait speed and other measures of physical function with cognition in a healthy cohort of elderly persons. J Gerontol A Biol Sci Med Sci. 2007 Nov;62(11):1244-51. doi: 10.1093/gerona/62.11.1244.
- Background: PubMed 17087700Nahin RL, Fitzpatrick AL, Williamson JD, Burke GL, Dekosky ST, Furberg C; GEM Study Investigators. Use of herbal medicine and other dietary supplements in community-dwelling older people: Baseline data from the ginkgo evaluation of memory study. J Am Geriatr Soc. 2006 Nov;54(11):1725-35. doi: 10.1111/j.1532-5415.2006.00942.x.
- Background: PubMed 15820233Rosano C, Aizenstein HJ, Cochran JL, Saxton JA, De Kosky ST, Newman AB, Kuller LH, Lopez OL, Carter CS. Event-related functional magnetic resonance imaging investigation of executive control in very old individuals with mild cognitive impairment. Biol Psychiatry. 2005 Apr 1;57(7):761-7. doi: 10.1016/j.biopsych.2004.12.031.
- Background: PubMed 16226041Rosano C, Aizenstein H, Cochran J, Saxton J, De Kosky S, Newman AB, Kuller LH, Lopez OL, Carter CS. Functional neuroimaging indicators of successful executive control in the oldest old. Neuroimage. 2005 Dec;28(4):881-9. doi: 10.1016/j.neuroimage.2005.05.059. Epub 2005 Oct 12.
- Background: PubMed 18165850Williamson JD, Vellas B, Furberg C, Nahin R, Dekosky ST. Comparison of the design differences between the Ginkgo Evaluation of Memory study and the GuidAge study. J Nutr Health Aging. 2008 Jan;12(1):73S-9S. doi: 10.1007/BF02982591.
- Background: PubMed 19279031Saxton J, Snitz BE, Lopez OL, Ives DG, Dunn LO, Fitzpatrick A, Carlson MC, Dekosky ST; GEM Study Investigators. Functional and cognitive criteria produce different rates of mild cognitive impairment and conversion to dementia. J Neurol Neurosurg Psychiatry. 2009 Jul;80(7):737-43. doi: 10.1136/jnnp.2008.160705. Epub 2009 Mar 11.
- Background: PubMed 19347684Snitz BE, Saxton J, Lopez OL, Ives DG, Dunn LO, Rapp SR, Carlson MC, Fitzpatrick AL, Dekosky ST; GEM study Investigators. Identifying mild cognitive impairment at baseline in the Ginkgo Evaluation of Memory (GEM) study. Aging Ment Health. 2009 Mar;13(2):171-82. doi: 10.1080/13607860802380656.
- Results publication: PubMed 19017911DeKosky ST, Williamson JD, Fitzpatrick AL, Kronmal RA, Ives DG, Saxton JA, Lopez OL, Burke G, Carlson MC, Fried LP, Kuller LH, Robbins JA, Tracy RP, Woolard NF, Dunn L, Snitz BE, Nahin RL, Furberg CD; Ginkgo Evaluation of Memory (GEM) Study Investigators. Ginkgo biloba for prevention of dementia: a randomized controlled trial. JAMA. 2008 Nov 19;300(19):2253-62. doi: 10.1001/jama.2008.683.
- Results publication: PubMed 20123670Kuller LH, Ives DG, Fitzpatrick AL, Carlson MC, Mercado C, Lopez OL, Burke GL, Furberg CD, DeKosky ST; Ginkgo Evaluation of Memory Study Investigators. Does Ginkgo biloba reduce the risk of cardiovascular events? Circ Cardiovasc Qual Outcomes. 2010 Jan;3(1):41-7. doi: 10.1161/CIRCOUTCOMES.109.871640. Epub 2009 Nov 24.
- Results publicationSnitz BE, O'Meara ES, Carlson MC, Arnold A, Ives DG, Rapp SR, Saxton J, Lopez OL, Dunn LO, Sink K, DeKosky ST for the Ginkgo Evaluation of Memory Study investigators. Ginkgo biloba in preventing cognitive decline in older adults: A randomized trial. Journal of the American Medical Aassociation, 2009, in press.
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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.
Steven T. DeKosky, M.D. principal investigator
University of Pittsburgh, Department of Neurology
5 sites 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 in people with Dementia and Alzheimer's Disease, run by National Center for Complementary and Integrative Health (NCCIH) at 5 sites 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 4 inclusion and 10 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 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Incident Dementia (time frame: Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00010803, which also lists 13 linked publications.
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 14 Mar 2013.