Vitamin E in Aging Persons With Down Syndrome

NCT00056329 | Unknown Phase 3 DMC

• 3 other identifiers: IA0039R01AG016381NIA Grant AG16381
• Study Type: interventional
• Target: 350
• Locations: 4 countries
• Sites: 22

Brief 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.

Conditions

Down Syndrome; Alzheimer Disease

Keywords

Aging Persons; Down Syndrome; Vitamin E; Alzheimer disease

Outcome Measures

Primary Outcomes (1)

• Brief Praxis Test, measuring cognitive functions expressed as performances of simple, short, sequences of voluntary movements

  Screening, Baseline, every 6 months for 36 months

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

vitamin E plus multivitamin

Drug: Vitamin E; Drug: multivitamin

2

PLACEBO COMPARATOR

placebo with multivitamin

Drug: multivitamin; Drug: Placebo

Interventions

Vitamin E DRUG

1,000 international units twice daily for three years

Also known as: tocopherol

1

multivitamin DRUG

once daily for three years

1; 2

Placebo DRUG

Placebo twice daily for three years

2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Institute for Basic Research: lead
• National Institute on Aging (NIA): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (22)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Roskamp Institute Memory Clinic

Tampa, Florida, 33617, United States

Location

Institute for the Study of Disadvantage and Disability

Atlanta, Georgia, 30342, United States

Location

May South, Inc.

Atlanta, Georgia, 30342, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9642, United States

Location

Third Age, Inc.

Lexington, Kentucky, 40517, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Clinical Research Center of New Jersey

Voorhees Township, New Jersey, 08043, United States

Location

University at Albany, SUNY

Albany, New York, 12222, United States

Location

Nathan Kline Institute

Orangeburg, New York, 10962, United States

Location

George Jervis Clinic

Staten Island, New York, 10314, United States

Location

Westchester Institute for Human Development

Valhalla, New York, 10595, United States

Location

University Memory and Aging Center, Case Western Reserve University

Cleveland, Ohio, 44120, United States

Location

Centre for Developmental Disabilities Studies

Ryde, New South Wales, 1680, Australia

Location

Down Syndrome Research Foundation

Port Coquitlam, British Columbia, V3C 2B2, Canada

Location

Surrey Place Centre

Toronto, Ontario, M5S 2C2, Canada

Location

Saskatoon City Hospital

Saskatoon, Saskatchewan, S7K 0M7, Canada

Location

University of Cambridge

Cambridge, England, CB2 2AH, United Kingdom

Location

Greenfields Monyhull Hospital

Kings Norton, Birmingham, England, B30 3QQ, United Kingdom

Location

Kings College: London

London, England, SE5 8AF, United Kingdom

Location

Mercer Institute for Research on Ageing, St. James Hospital

Dublin, Ireland, 8, United Kingdom

Location

Related Publications (5)

• 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. doi: 10.1056/NEJM199704243361704.

  PMID: 9110909 BACKGROUND

• Aisen PS, Davis KL. The search for disease-modifying treatment for Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 6):S35-41. doi: 10.1212/wnl.48.5_suppl_6.35s.

  PMID: 9153159 BACKGROUND

• 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. doi: 10.1111/j.1365-2788.1997.tb00692.x.

  PMID: 9161927 BACKGROUND

• 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.

  BACKGROUND

• 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 Intellectual Disabilities. 2005 2(2):126-138.

  RESULT

MeSH Terms

Conditions

Down Syndrome; Alzheimer Disease

Interventions

Vitamin E; Tocopherols; Geritol

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Arthur J Dalton, PhD

  New York State Institute for Basic Research in Developmental Disabilities

  PRINCIPAL INVESTIGATOR

• Paul S Aisen, MD

  Georgetown University

  STUDY DIRECTOR

• Mary C Sano, PhD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: March 10, 2003
• First Posted: March 12, 2003
• Study Start: April 1, 2002
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 4, 2012

Record last verified: 2012-05

Locations

CA (3); US (14); GB (4); AU (1)