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Alzheimer's DiseasePhase 3NCT00056225

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

A Phase 3 study testing Folate, Vitamin B6 and Vitamin B12 in people with Alzheimer's Disease, run by National Institute on Aging (NIA) at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Folate, Vitamin B6 and Vitamin B12
How many people
340 participants
Where
38 sitesUnited States
Study dates
Jan 2003to Jun 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30329

  • University of Alabama

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush Presbyterian/St. Lukes Medical Center, Rush Alzheimer's Disease Center

    Chicago, Illinois, 60612

  • University Memory and Aging Center, Case Western Reserve University/University Hospitals of Cleveland

    Cleveland, Ohio, 44120

  • University of Texas, Southwestern Medical Center

    Dallas, Texas, 75390

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of California, Irvine, Institute for Brain Aging and Dementia

    Irvine, California, 92697

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • ClinSearch

    Kenilworth, New Jersey, 07033

  • University of California, San Diego

    La Jolla, California, 92093-0624

  • University of Nevada School of Medicine, Center for Cognitive Aging

    Las Vegas, Nevada, 89102

  • University of Southern California

    Los Angeles, California, 90033

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Yale University

    New Haven, Connecticut, 06510

  • New York University Medical Center

    New York, New York, 10016

  • Mt. Sinai School of Medicine

    New York, New York, 10029

  • Columbia University

    New York, New York, 10032

  • Medical University of South Carolina

    North Charleston, South Carolina, 29406

  • Stanford University

    Palo Alto, California, 94304

  • Memorial Hospital of Rhode Island, Alzheimer's Disease and Memory Disorder Clinic

    Pawtucket, Rhode Island, 02860

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health and Science University, Oregon Aging and Alzheimer's Disease Center

    Portland, Oregon, 97201

  • University of Rochester Medical Center, Alzheimer's Disease Center

    Rochester, New York, 14620

  • University of California, Davis

    Sacramento, California, 95817

  • Mayo Clinic, Scottsdale

    Scottsdale, Arizona, 85259

  • University of Washington

    Seattle, Washington, 98108

  • Southern Illinois University

    Springfield, Illinois, 62794-9643

  • Sun Health Research Institute

    Sun City, Arizona, 85351

  • University of South Florida

    Tampa, Florida, 33617

  • University of Arizona, Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • Georgetown University

    Washington D.C., District of Columbia, 20057

  • Howard University

    Washington D.C., District of Columbia, 20060

Other trials in United States

About this 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)

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.

Read the 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.

Being tested
Folate, Vitamin B6, Vitamin B12
Keywords
homocysteine
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FolateDrug

  • Vitamin B6Drug

  • Vitamin B12Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2003 (estimated)
  2. Study startJan 2003
  3. Primary completionJun 2007
  4. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00056225
Sponsor's protocol ID
IA0041
Status last verified
Jun 2009
First submitted
7 Mar 2003
Last updated
12 Jun 2009
Results posted
No

Publications

  • 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.

    PubMed 11844848

  • 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.

    PubMed 12611755

  • 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.

    PubMed 11880504

  • 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.

    PubMed 18854539

  • Jimenez-Maggiora GA, Donohue MC, Rafii MS, Raman R, Aisen PS. Artificial intelligence-enabled safety monitoring in Alzheimer's disease clinical trials. J Prev Alzheimers Dis. 2025 Jan;12(1):100002. doi: 10.1016/j.tjpad.2024.100002. Epub 2025 Jan 1.

    PubMed 39800465

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Folate, Vitamin B6 and Vitamin B12 in people with Alzheimer's Disease, run by National Institute on Aging (NIA) at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00056225, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2009.

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