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VITAL - VITamins to Slow ALzheimer's Disease (Homocysteine Study)

This study has been completed.

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00056225
  Purpose

The purpose of this study is to determine whether reduction of homocysteine levels with high-dose folate (folic acid), B6, and B12 supplementation will slow the rate of cognitive decline in persons with Alzheimer's disease.


Condition Intervention Phase
Alzheimer's Disease
Drug: Folate
Drug: Vitamin B6
Drug: Vitamin B12
Phase III

Genetics Home Reference related topics:   Alzheimer disease  

MedlinePlus related topics:   Alzheimer's Disease  

ChemIDplus related topics:   Folic acid   Vitamin B 12   Hydroxocobalamin   Vitamin B 6   5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride   Pyridoxine   Homocysteine  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   High Dose Supplements to Reduce Homocysteine and Slow the Rate of Cognitive Decline in Alzheimer's Disease (Vitamins to Slow Alzheimer's - VITAL)

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment:   400
Study Start Date:   January 2003
Estimated Study Completion Date:   February 2006

Detailed Description:

Blood levels of homocysteine are elevated in Alzheimer’s disease (AD), and hyperhomocysteinemia may contribute to disease pathophysiology by vascular and direct neurotoxic mechanisms. Homocysteine levels can be reduced by administration of high dose supplements of folate (folic acid) and vitamins B6 and B12. The proposed study is for a multicenter, randomized, controlled clinical trial to determine whether reduction of homocysteine levels with high-dose folate/B6/B12 supplementation will slow the rate of cognitive decline in subjects with AD.

This will be a parallel design study, including two groups of unequal size: 60% of subjects will receive daily high-dose supplements (folate 5mg, vitamin B6 25mg, vitamin B12 1 mg), and 40% will receive an identical looking placebo. The duration of treatment will be 18 months, and participants will make eight visits to the assigned study site for safety and efficacy assessments of the medications. The primary outcome measure will be the longitudinal decline in the ADAScog, a psychometric instrument that evaluates memory, attention, reasoning, language, orientation and praxis (Rosen et al 1984). To power the trial to detect a 25% reduction in rate of ADAScog decline (80% power, alpha=0.05, drop-out estimate 20%, drop-in estimate 10%), it will enroll a total of 400 participants. Persons of minority racial groups are also being recruited, although all participants must be able to speak either English or Spanish.

  Eligibility
Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • National Institute of Neurological Disorders and Stroke (NINDS)/Alzheimer's Disease and Related Disorders Association (ADRDA) criteria for probable Alzheimer's disease.
  • Mini-Mental Status Examination (MMSE) score between 14 and 26, inclusive
  • Stable medical condition for 3 months
  • Stable medications for 4 weeks prior to the screening visit
  • Physically acceptable for this study as confirmed by medical history, physical exam, neurologic exam and clinical laboratory tests
  • Supervision available for administration of study medications
  • Study partner to accompany subject to all scheduled visits
  • Fluent in English or Spanish
  • Modified Hachinski equal to or less than 4 CT or magnetic resonance imaging (MRI) since onset of memory impairment demonstrating absence of clinically significant focal lesion
  • Able to complete baseline assessments
  • 6 years of education or work history sufficient to exclude mental retardation
  • Able to ingest oral medication

Exclusion Criteria:

  • B12 or folate deficiency
  • Renal insufficiency (serum creatinine >=2.0)
  • Active neoplastic disease (skin tumors other than melanoma are not exclusionary; patients with stable prostate cancer may be included at the discretion of the project director)
  • Use of another investigational agent within 2 months
  • History of clinically significant stroke
  • Current evidence or history in the past 2 years of epilepsy, focal brain lesion, head injury with loss of consciousness and/or immediate confusion after the injury, or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
  • Blindness, deafness, language difficulties or any other disability which may prevent the subject from participating or cooperating in the protocol
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056225

 Show 38 Study Locations

Sponsors and Collaborators

Investigators
Principal Investigator:     Paul Aisen, MD     Georgetown University, Department of Neurology    
  More Information

Publications:

Study ID Numbers:   IA0041
First Received:   March 7, 2003
Last Updated:   March 14, 2007
ClinicalTrials.gov Identifier:   NCT00056225
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
homocysteine  

Study placed in the following topic categories:
Alzheimer Disease
Hydroxocobalamin
Central Nervous System Diseases
Vitamin B 12
Brain Diseases
Neurodegenerative Diseases
Cognition Disorders
Vitamin B 6
Folic Acid
Delirium, Dementia, Amnestic, Cognitive Disorders
Pyridoxine
Dementia
Delirium

Additional relevant MeSH terms:
Vitamin B Complex
Mental Disorders
Growth Substances
Vitamins
Physiological Effects of Drugs
Nervous System Diseases
Micronutrients
Tauopathies
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008




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