Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00056329




Registration number
NCT00056329
Ethics application status
Date submitted
10/03/2003
Date registered
12/03/2003
Date last updated
4/05/2012

Titles & IDs
Public title
Vitamin E in Aging Persons With Down Syndrome
Scientific title
Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
Secondary ID [1] 0 0
R01AG016381
Secondary ID [2] 0 0
IA0039
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Down Syndrome 0 0
Alzheimer Disease 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 - Vitamin E
Treatment: Drugs - multivitamin
Treatment: Drugs - Placebo

Experimental: 1 - vitamin E plus multivitamin

Placebo comparator: 2 - placebo with multivitamin


Treatment: Drugs: Vitamin E
1,000 international units twice daily for three years

Treatment: Drugs: multivitamin
once daily for three years

Treatment: Drugs: Placebo
Placebo twice daily for three years
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Brief Praxis Test, measuring cognitive functions expressed as performances of simple, short, sequences of voluntary movements
Timepoint [1] 0 0
Screening, Baseline, every 6 months for 36 months
Secondary outcome [1] 0 0
Fuld Object Memory Test (Modified), New Dot Test, Orientation Test, Vocabulary Test, Behavior & Function Down Syndrome Rating Scale, Clinical Global Impression of Change (CGI-C)
Timepoint [1] 0 0
Screening, Baseline, and every 6 months for 36 months

Eligibility
Key inclusion criteria
* Presence of clinically determined Down syndrome (karyotypes optional).
* Medically stable.
* Medications stable over 3 months.
* Appropriately signed and witnessed consent form.
* 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's disease) associated with dementia.
* Brief Praxis Test score <20.
* Modified Hachinski score >4.
* Major depression within 3 months.
* History of any disorder of blood coagulation (inherited or acquired).
* Current use of anti-coagulants.
* Use of experimental medications within 3 months.
* Regular use of vitamin E greater than 50 units per day during the previous 6 months.

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 assessing the outcomes
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2012
Actual
Sample size
Target
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Centre for Developmental Disabilities Studies - Ryde
Recruitment postcode(s) [1] 0 0
1680 - Ryde
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Saskatchewan
Country [13] 0 0
United Kingdom
State/province [13] 0 0
England
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Ireland

Funding & Sponsors
Primary sponsor type
Government body
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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arthur J Dalton, PhD
Address 0 0
New York State Institute for Basic Research in Developmental Disabilities
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Sano M, Aisen PS, Dalton AJ, Andrews HF, Tsai W-Y,... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00056329