We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00056225
Recruitment Status : Completed
First Posted : March 10, 2003
Last Update Posted : June 12, 2009
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE March 7, 2003
First Posted Date  ICMJE March 10, 2003
Last Update Posted Date June 12, 2009
Study Start Date  ICMJE January 2003
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE VITAL - VITamins to Slow ALzheimer's Disease (Homocysteine Study)
Official Title  ICMJE High Dose Supplements to Reduce Homocysteine and Slow the Rate of Cognitive Decline in Alzheimer's Disease (Vitamins to Slow Alzheimer's - VITAL)
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: Folate
  • Drug: Vitamin B6
  • Drug: Vitamin B12
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2008)
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00056225
Other Study ID Numbers  ICMJE IA0041
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Institute on Aging (NIA)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Alzheimer's Disease Cooperative Study (ADCS)
Investigators  ICMJE
Principal Investigator: Paul Aisen, MD Georgetown University, Department of Neurology
PRS Account National Institute on Aging (NIA)
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP