search
Back to results

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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Folate
Vitamin B6
Vitamin B12
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring homocysteine

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Mayo Clinic, Scottsdale
  • Sun Health Research Institute
  • University of Arizona, Arizona Health Sciences Center
  • University of California, Irvine, Institute for Brain Aging and Dementia
  • University of California, San Diego
  • University of Southern California
  • University of California, Los Angeles
  • Stanford University
  • University of California, Davis
  • Yale University
  • Georgetown University
  • Howard University
  • Mayo Clinic
  • University of South Florida
  • Emory University
  • Northwestern University
  • Rush Presbyterian/St. Lukes Medical Center, Rush Alzheimer's Disease Center
  • Southern Illinois University
  • Indiana University
  • Brigham and Women's Hospital
  • Boston University School of Medicine
  • University of Michigan
  • University of Nevada School of Medicine, Center for Cognitive Aging
  • ClinSearch
  • New York University Medical Center
  • Mt. Sinai School of Medicine
  • Columbia University
  • University of Rochester Medical Center, Alzheimer's Disease Center
  • University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland
  • Oregon Health and Science University, Oregon Aging and Alzheimer's Disease Center
  • University of Pennsylvania
  • University of Pittsburgh
  • Memorial Hospital of Rhode Island, Alzheimer's Disease and Memory Disorder Clinic
  • Medical University of South Carolina
  • University of Texas, Southwestern Medical Center
  • Baylor College of Medicine
  • University of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2003
Last Updated
June 10, 2009
Sponsor
National Institute on Aging (NIA)
Collaborators
Alzheimer's Disease Cooperative Study (ADCS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00056225
Brief Title
VITAL - VITamins to Slow ALzheimer's Disease (Homocysteine 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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)
Collaborators
Alzheimer's Disease Cooperative Study (ADCS)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
homocysteine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Folate
Intervention Type
Drug
Intervention Name(s)
Vitamin B6
Intervention Type
Drug
Intervention Name(s)
Vitamin B12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Aisen, MD
Organizational Affiliation
Georgetown University, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic, Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
University of Arizona, Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of California, Irvine, Institute for Brain Aging and Dementia
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0624
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University
City
Washington, DC
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Howard University
City
Washington, DC
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Presbyterian/St. Lukes Medical Center, Rush Alzheimer's Disease Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Southern Illinois University
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9643
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Nevada School of Medicine, Center for Cognitive Aging
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
ClinSearch
City
Kenilworth
State/Province
New Jersey
ZIP/Postal Code
07033
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mt. Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center, Alzheimer's Disease Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44120
Country
United States
Facility Name
Oregon Health and Science University, Oregon Aging and Alzheimer's Disease Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Memorial Hospital of Rhode Island, Alzheimer's Disease and Memory Disorder Clinic
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Medical University of South Carolina
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
University of Texas, Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11844848
Citation
Seshadri S, Beiser A, Selhub J, Jacques PF, Rosenberg IH, D'Agostino RB, Wilson PW, Wolf PA. Plasma homocysteine as a risk factor for dementia and Alzheimer's disease. N Engl J Med. 2002 Feb 14;346(7):476-83. doi: 10.1056/NEJMoa011613.
Results Reference
background
PubMed Identifier
12611755
Citation
Aisen PS, Egelko S, Andrews H, Diaz-Arrastia R, Weiner M, DeCarli C, Jagust W, Miller JW, Green R, Bell K, Sano M. A pilot study of vitamins to lower plasma homocysteine levels in Alzheimer disease. Am J Geriatr Psychiatry. 2003 Mar-Apr;11(2):246-9.
Results Reference
background
PubMed Identifier
11880504
Citation
Kruman II, Kumaravel TS, Lohani A, Pedersen WA, Cutler RG, Kruman Y, Haughey N, Lee J, Evans M, Mattson MP. Folic acid deficiency and homocysteine impair DNA repair in hippocampal neurons and sensitize them to amyloid toxicity in experimental models of Alzheimer's disease. J Neurosci. 2002 Mar 1;22(5):1752-62. doi: 10.1523/JNEUROSCI.22-05-01752.2002.
Results Reference
background
PubMed Identifier
18854539
Citation
Aisen PS, Schneider LS, Sano M, Diaz-Arrastia R, van Dyck CH, Weiner MF, Bottiglieri T, Jin S, Stokes KT, Thomas RG, Thal LJ; Alzheimer Disease Cooperative Study. High-dose B vitamin supplementation and cognitive decline in Alzheimer disease: a randomized controlled trial. JAMA. 2008 Oct 15;300(15):1774-83. doi: 10.1001/jama.300.15.1774.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs