Vitamin E in Aging Persons With Down Syndrome

Alzheimer Disease Clinical Trial

Official title:

Multicenter Vitamin E Trial in Aging Persons With Down Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00056329
• Other study ID #: IA0039
• Secondary ID: R01AG016381NIA G
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 10, 2003
• Last updated: May 2, 2012
• Start date: April 2002
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: New York State Institute for Basic Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to determine the safety and efficacy of the administration of vitamin E, which has been shown to delay the progression of Alzheimer's disease, in slowing the rate of cognitive/functional decline in older persons with Down syndrome.

Description:

The growing success of therapeutic interventions (including the antioxidant Vitamin E) for Alzheimer's disease in the general population requires a solution to the methodological problems so that therapeutic trials can be conducted in the aging population with Down syndrome which will ultimately improve their quality of life as well as that of their families and caregivers. The experience gained in this trial will be useful to the design of appropriate cognitive measures of Alzheimer's disease in persons with Down syndrome in subsequent trials.

The goal of this international three-year study is to determine whether the administration of vitamin E, which has been shown to delay the progression of Alzheimer's disease, will slow the rate of cognitive/functional decline in persons age 50 or older with Down syndrome. Persons with Down syndrome functioning at all levels of intellectual disability will be eligible. Men and women of approximately equal numbers and people from minorities and ethnic groups other than Caucasian will be included. A total of 350 individuals with Down syndrome, 50 years of age and older, have been recruited at approximately 21 trial sites. The study is a randomized, double-blind, placebo-controlled, parallel group design with stratification by geographic site and presence of Alzheimer disease according to DSM-IV (American Psychiatric Association) criteria for diagnosing this disease.

Apolipoprotein E (Apo E) genotype will be determined at the screening visit to allow secondary analyses of the impact of Apo E genotype (that may influence Alzheimer's disease risk) on outcome measures and the response to treatment. DNA specimens will also be stored for possible future genetic analyses, with trial sites allowing for non-participation in this procedure. Visits will occur at baseline and then at 6 monthly intervals, with each visit including interval medical history, current and interval medications, side effects checklist, adverse events, pill count, institutionalization status, cognitive, functional, and behavioral measures, and DSM-IV diagnostic assessment for Alzheimer's disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Down Syndrome
• Syndrome

Intervention

Drug:
• Vitamin E
1,000 international units twice daily for three years
• multivitamin
once daily for three years
• Placebo
Placebo twice daily for three years

Locations

Country	Name	City	State
Australia	Centre for Developmental Disabilities Studies	Ryde	New South Wales
Canada	Down Syndrome Research Foundation	Port Coquitlam	British Columbia
Canada	Saskatoon City Hospital	Saskatoon	Saskatchewan
Canada	Surrey Place Centre	Toronto	Ontario
United Kingdom	University of Cambridge	Cambridge	England
United Kingdom	Mercer Institute for Research on Ageing, St. James Hospital	Dublin	Ireland
United Kingdom	Greenfields Monyhull Hospital	Kings Norton, Birmingham	England
United Kingdom	Kings College: London	London	England
United States	University at Albany, SUNY	Albany	New York
United States	Institute for the Study of Disadvantage and Disability	Atlanta	Georgia
United States	May South, Inc.	Atlanta	Georgia
United States	McLean Hospital	Belmont	Massachusetts
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University Memory and Aging Center, Case Western Reserve University	Cleveland	Ohio
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Third Age, Inc.	Lexington	Kentucky
United States	Nathan Kline Institute	Orangeburg	New York
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	George Jervis Clinic	Staten Island	New York
United States	Roskamp Institute Memory Clinic	Tampa	Florida
United States	Westchester Institute for Human Development	Valhalla	New York
United States	Clinical Research Center of New Jersey	Voorhees	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
New York State Institute for Basic Research	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  United Kingdom, 

References & Publications (5)

Aisen PS, Davis KL. The search for disease-modifying treatment for Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 6):S35-41. Review. — View Citation

Aylward EH, Burt DB, Thorpe LU, Lai F, Dalton A. Diagnosis of dementia in individuals with intellectual disability. J Intellect Disabil Res. 1997 Apr;41 ( Pt 2):152-64. — View Citation

Dalton, AJ, Mehta, PD, Fedor, BL, Patti, PJ: Cognitive changes in memory precede those in praxis in aging persons with Down syndrome. Journal of Intellectual and Developmental Disability 24(2):169-187,1999.

Sano M, Aisen PS, Dalton AJ, Andrews HF, Tsai W-Y, and the International Down Syndrome Alzheimer Disease Consortium. Assessment of aging individuals with Down syndrome in clinical trials: results of baseline measures. Journal of Policy and Practice in Int

Sano M, Ernesto C, Thomas RG, Klauber MR, Schafer K, Grundman M, Woodbury P, Growdon J, Cotman CW, Pfeiffer E, Schneider LS, Thal LJ. A controlled trial of selegiline, alpha-tocopherol, or both as treatment for Alzheimer's disease. The Alzheimer's Disease Cooperative Study. N Engl J Med. 1997 Apr 24;336(17):1216-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Praxis Test, measuring cognitive functions expressed as performances of simple, short, sequences of voluntary movements		Screening, Baseline, every 6 months for 36 months	No
Secondary	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)		Screening, Baseline, and every 6 months for 36 months	No