Alzheimer's DiseasePhase 3NCT01594346
Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
A Phase 3 study testing Alpha-Tocopherol and Sugar Pill in people with Alzheimer's Disease and Down Syndrome, run by New York State Institute for Basic Research.
Trial summary
The purpose of this study is to determine the safety and effectiveness of 2,000 international units of Vitamin E (alpha tocopherol)on cognitive function of aging persons with Down syndrome. It is a randomized, double-blind, placebo-controlled trial lasting 36 months. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease, Down Syndrome
- What is being tested?
- Alpha-Tocopherol and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 349 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Apr 2010
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of clinically determined Down syndrome (karyotypes optional)
- appropriately signed and witnessed consent form
- age of 50 years or older at the start of the protocol
- medically stable
- medications stable more than 1 month
- involvement/cooperation of informant/caregiver
Who cannot join
- medical/neurological condition (other than Alzheimer disease) associated with dementia
- inability to adequately perform the Brief Praxis Test, as demonstrated by a score <20
- in the presence of dementia, modified Hachinski score > 4 at Screening Visit
- major depression within 3 months
- history of coagulopathy (inherited or acquired)
- current use of anticoagulants
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- use of experimental medications within 2 months
- regular use of vitamin E greater than 50 units per day during the previous 6 months
- allergy to vitamin E
About this study
The purpose of this study is to determine the safety and effectiveness of 2,000 international units of Vitamin E (alpha tocopherol)on cognitive function of aging persons with Down syndrome. It is a randomized, double-blind, placebo-controlled trial lasting 36 months. It is expected that Vitamin E will slow the deterioration in cognitive functions associated with Alzheimer disease.
Read the detailed description
Alzheimer disease (AD) continues to be the most serious health problem faced by aging persons with Down syndrome. AD is also a major public health concern in the aging general population. With increasing life expectancy there will be a dramatic increase in the prevalence of AD cases, which will pose a significant increased burden on the health care system and individual providers of care. Persons with Down syndrome are uniquely vulnerable to a form of Alzheimer disease indistinguishable from the sporadic variety that affects aging individuals from the general population. Oxidative damage is a highly plausible mechanism in the pathogenesis of this disease due to the overexpression of superoxide dismutase, associated with a gene located on chromosome 21, which is present in triplicate in the Down syndrome genotype. For the last six years, we have been conducting a clinical trial to determine the safety and efficacy of the anti-oxidant Vitamin E in slowing the cognitive and functional decline associated with the dementia of AD among individuals with DS. The study is a randomized, double-blind trial, stratified in a two-arm parallel design. The subjects are medically stable individuals who are 50 years of age or older at the time of screening. Among those randomized to the treatment arm, vitamin E is taken in the form of 1000 IU capsules for 36 months. Each subject is evaluated every 6 months for 3 years. The primary outcome is is the Brief Praxis Test (BPT), which is well-suited to quantifying cognitive decline in this population. The target enrollment of 350 persons is estimated to be sufficient to provide adequate statistical power to detect a slowing by one-third in the rate of cognitive decline with vitamin E treatment. The Data and Safety Monitoring Board (DSMB) for this trial includes 4 physicians, and a statistician with expertise in clinical trials. Each DSMB member receives a report on each serious adverse event (SAE) on a flow basis, and statistically summaries of unblinded safety data--including deaths, adverse events and vital signs--prior to each meeting of the DSMB. The most recent DSMB meeting took place on February 23,2010. The timeline for study completion is: recruitment of the study sample (N=350) was completed on 12/31/2008; the final 36-month evaluation will take place in 04/2010; statistical analysis and final report of results is expected to be completed by 12/31/2010.
- Conditions
- Alzheimer's Disease, Down Syndrome
- Being tested
- Alpha-Tocopherol, Sugar Pill
- Keywords
- Vitamin E, alpha-tocopherol, cognitive decline, Down syndrome, Aging, Dementia
- Medical subject headings
- Alzheimer Disease, Down Syndrome, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-TocopherolDrug
Also called Vitamin E
1,000 International Units, two times a day for 36 months
Sugar PillDrug
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Not described Receives: Drug: Sugar Pill |
| Alpha-Tocopherol | Active comparator | Not described Receives: Drug: Alpha-Tocopherol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Brief Praxis Test
Measured: 36 months
Secondary outcomes (7)
The Fuld Object Memory Test
Measured: 36 Months
New Dot Test
Measured: 36 Months
Orientation Test
Measured: 36 Months
Vocabulary Test
Measured: 36 Months
Behavior and Function
Measured: 36 Months
Clinical Global Impression
Measured: 36 Months
Incident Dementia
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startSep 2000
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Institute for Basic Research
- Sponsor type
- Other government
- Collaborators
- National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH), New York State Psychiatric Institute, University of California, San Diego, Columbia University, Bronx Veterans Medical Research Foundation, Inc
- Responsible party
- Principal investigator, Arthur Dalton, New York State Institute for Basic Research
- Investigators
- Paul S. Aisen, M.D., Study director, University of California, San DiegoMary C. Sano, Ph.D., Study director, Bronx Veterans Medical Research FoundationHoward F. Andrews, Ph.D., Study director, New York Psychiatric InstituteWei-Yann Tsai, Ph.D., Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594346
- Sponsor's protocol ID
- NCT00056329
- Other IDs
- R01AG016381
- Status last verified
- May 2012
- First submitted
- 2 May 2012
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
- ClinicalTrials.gov ID
- NCT01594346
- Acronym / sponsor ID
- NCT00056329
- Conditions
- Alzheimer's Disease, Down Syndrome
- Keywords
- Vitamin E, alpha-tocopherol, cognitive decline, Down syndrome, Aging, Dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- New York State Institute for Basic ResearchOther government
- Collaborators
- National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH), New York State Psychiatric Institute, University of California, San Diego, Columbia University, Bronx Veterans Medical Research Foundation, Inc
- Study start
- Sep 2000
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 9 May 2012 (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 purpose of this study is to determine the safety and effectiveness of 2,000 international units of Vitamin E (alpha tocopherol)on cognitive function of aging persons with Down syndrome. It is a randomized, double-blind, placebo-controlled trial lasting 36 months. It is expected that Vitamin E will slow the deterioration in cognitive functions associated with Alzheimer disease.
Detailed description
Alzheimer disease (AD) continues to be the most serious health problem faced by aging persons with Down syndrome. AD is also a major public health concern in the aging general population. With increasing life expectancy there will be a dramatic increase in the prevalence of AD cases, which will pose a significant increased burden on the health care system and individual providers of care. Persons with Down syndrome are uniquely vulnerable to a form of Alzheimer disease indistinguishable from the sporadic variety that affects aging individuals from the general population. Oxidative damage is a highly plausible mechanism in the pathogenesis of this disease due to the overexpression of superoxide dismutase, associated with a gene located on chromosome 21, which is present in triplicate in the Down syndrome genotype. For the last six years, we have been conducting a clinical trial to determine the safety and efficacy of the anti-oxidant Vitamin E in slowing the cognitive and functional decline associated with the dementia of AD among individuals with DS. The study is a randomized, double-blind trial, stratified in a two-arm parallel design. The subjects are medically stable individuals who are 50 years of age or older at the time of screening. Among those randomized to the treatment arm, vitamin E is taken in the form of 1000 IU capsules for 36 months. Each subject is evaluated every 6 months for 3 years. The primary outcome is is the Brief Praxis Test (BPT), which is well-suited to quantifying cognitive decline in this population. The target enrollment of 350 persons is estimated to be sufficient to provide adequate statistical power to detect a slowing by one-third in the rate of cognitive decline with vitamin E treatment. The Data and Safety Monitoring Board (DSMB) for this trial includes 4 physicians, and a statistician with expertise in clinical trials. Each DSMB member receives a report on each serious adverse event (SAE) on a flow basis, and statistically summaries of unblinded safety data--including deaths, adverse events and vital signs--prior to each meeting of the DSMB. The most recent DSMB meeting took place on February 23,2010. The timeline for study completion is: recruitment of the study sample (N=350) was completed on 12/31/2008; the final 36-month evaluation will take place in 04/2010; statistical analysis and final report of results is expected to be completed by 12/31/2010.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: Sugar Pill |
| Alpha-Tocopherol | Active comparator | Drug: Alpha-Tocopherol |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- presence of clinically determined Down syndrome (karyotypes optional)
- appropriately signed and witnessed consent form
- age of 50 years or older at the start of the protocol
- medically stable
- medications stable more than 1 month
Key exclusion criteria (9 listed)
- medical/neurological condition (other than Alzheimer disease) associated with dementia
- inability to adequately perform the Brief Praxis Test, as demonstrated by a score <20
- in the presence of dementia, modified Hachinski score > 4 at Screening Visit
- major depression within 3 months
- history of coagulopathy (inherited or acquired)
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 |
|---|---|---|
| Alpha-TocopherolAlso: Vitamin E1,000 International Units, two times a day for 36 months | Drug | Alpha-Tocopherol |
| Sugar Pill | Drug | Sugar Pill |
Primary outcome
The Brief Praxis Test
Time frame: 36 months
7 secondary outcomes
The Fuld Object Memory Test
Time frame: 36 Months
New Dot Test
Time frame: 36 Months
Orientation Test
Time frame: 36 Months
Vocabulary Test
Time frame: 36 Months
Behavior and Function
Time frame: 36 Months
Clinical Global Impression
Time frame: 36 Months
Incident Dementia
Time frame: 36 Months
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 9 May 2012.
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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.
Paul S. Aisen, M.D. study director
University of California, San Diego
Mary C. Sano, Ph.D. study director
Bronx Veterans Medical Research Foundation
Howard F. Andrews, Ph.D. study director
New York Psychiatric Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alpha-Tocopherol and Sugar Pill in people with Alzheimer's Disease and Down Syndrome, run by New York State Institute for Basic Research.
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 6 inclusion and 9 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 9 May 2012. 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?
The Brief Praxis Test (time frame: 36 months). 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 9 May 2012.