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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01594346




Registration number
NCT01594346
Ethics application status
Date submitted
2/05/2012
Date registered
9/05/2012
Date last updated
9/05/2012

Titles & IDs
Public title
Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
Scientific title
Secondary ID [1] 0 0
R01AG016381
Secondary ID [2] 0 0
NCT00056329
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Down Syndrome 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Human Genetics and Inherited Disorders 0 0 0 0
Down's syndrome
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alpha-Tocopherol
Treatment: Drugs - Sugar Pill

Placebo Comparator: Sugar Pill -

Active Comparator: Alpha-Tocopherol -


Treatment: Drugs: Alpha-Tocopherol
1,000 International Units, two times a day for 36 months

Treatment: Drugs: Sugar Pill
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Brief Praxis Test
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
The Fuld Object Memory Test
Timepoint [1] 0 0
36 Months
Secondary outcome [2] 0 0
New Dot Test
Timepoint [2] 0 0
36 Months
Secondary outcome [3] 0 0
Orientation Test
Timepoint [3] 0 0
36 Months
Secondary outcome [4] 0 0
Vocabulary Test
Timepoint [4] 0 0
36 Months
Secondary outcome [5] 0 0
Behavior and Function
Timepoint [5] 0 0
36 Months
Secondary outcome [6] 0 0
Clinical Global Impression
Timepoint [6] 0 0
36 Months
Secondary outcome [7] 0 0
Incident Dementia
Timepoint [7] 0 0
36 Months

Eligibility
Key inclusion criteria
- 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
Accrual to date
Final
349
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
New York State Institute for Basic Research
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute on Aging (NIA)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
National Center for Complementary and Integrative Health (NCCIH)
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
New York State Psychiatric Institute
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of California, San Diego
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Columbia University
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Bronx Veterans Medical Research Foundation, Inc
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. It is
expected that Vitamin E will slow the deterioration in cognitive functions associated with
Alzheimer disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01594346
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Paul S. Aisen, M.D.
Address 0 0
University of California, San Diego
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries