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A Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborators:
University of Massachusetts, Lowell
Alzheimer's Association
Information provided by (Responsible Party):
Ruth Remington, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01320527
First received: March 21, 2011
Last updated: April 23, 2012
Last verified: April 2012
History of Changes

March 21, 2011
April 23, 2012
August 2008
April 2012   (final data collection date for primary outcome measure)
cognitive improvement or maintenance of cognitive performance [ Time Frame: within 3 months of treatment ] [ Designated as safety issue: No ]
Prior studies demonstrate cognitive improvement when treatment was initiated prior to or during mild-moderate Alzheimer's disease, and maintenance/ delayed decline in cognitive performance when treatment was initiated during moderate-severe Alzheimer's disease
Same as current
Complete list of historical versions of study NCT01320527 on ClinicalTrials.gov Archive Site
behavioral/psychotic symptoms [ Time Frame: within 3 months after initiation of treatment ] [ Designated as safety issue: No ]
Prior studies demonstrate improvement in mood and other behavioral symptoms when treatment was initiated during mild-moderate Alzheimer's disease, and maintenance/ delayed decline in mood and other behavioral symptoms when treatment was initiated during moderate-severe Alzheimer's disease
Same as current
Not Provided
Not Provided
 
A Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease
A Phase II Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease

Based on prior published pilot studies, the investigators have initiated a larger, multi-site placebo-controlled clinical trial with Alzheimer's disease (AD) patients and individuals diagnosed with Mild Cognitive Impairment (MCI), with the hopes of (1) confirming (or denying) the above promising clinical findings, and (2) determining whether or not our formulation can delay MCI "conversion" to AD.

Preclinical studies with mouse models of of age-related neurodegeneration led us to develop a Nutriceutical Formulation ("NF") consisting of 6 over-the-counter vitamins and nutriceuticals, that buffers multiple facets of Alzheimer's disease (AD), including (1) reducing presenilin expression, gamma-secretase activity, Abeta generation and tau phosphorylation, (2) buffering homocysteine and Abeta-induced oxidative damage, (3) reducing aggression, (4) increasing acetylcholine production and improving/maintaining cognitive performance.

A 1-year, open-label trial with NF with mild to moderate AD patients demonstrate improvement in cognitive performance (Dementia Rating Scale, Clock-drawing) within 3-6 months. Caregivers reported maintenance of daily performance and improved mood (ADCS-Activities of Daily Living and NeuroPsychiatric Inventory). A placebo-controlled study with moderate to late-stage AD indicates delayed cognitive decline and maintenance of daily activities. No adverse events were reported.

A multi-site trial with >90 individuals aged 45-73 without dementia indicated that NF statistically improved executive function (Trails B-A) vs. placebo within 3 months, which increased further at 6 months. The placebo group demonstrated identical improvement in a 3-month open-label extension. Following NF withdrawal, participants returned to baseline; statistically-significant improvement was restored once NF was individuals resumed.

We have initiated a larger, multi-site placebo-controlled clinical trial with AD patients and individuals diagnosed with Mild Cognitive Impairment (MCI), with the hopes of (1) confirming (or denying) the above promising clinical findings, and (2) determining whether or not our formulation can delay MCI "conversion" to AD.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alzheimer's Disease
  • Mild Cognitive Impairment
  • Dietary Supplement: Nutriceutical formulation
    Two pills that collectively contain: folic acid (400µg), Vitamin B12 (6µg), Vitamin E (as alpha-tocopherol; 30 IU), S-adenosylmethionine (SAM; 400mg), N-acetyl cysteine (NAC; 600mg) and Acetyl-L-carnitine (ALCAR; 500mg). Taken once daily for duration of study (1 year).
    Other Name: MemoryXL
  • Dietary Supplement: Nutriceutical formulation
    A mixture of 6 vitamins and nutriceuticals
    Other Names:
    • MemoryXL
    • GreatMind
Experimental: Nutriceutical formulation
Nutritional supplement
Interventions:
  • Dietary Supplement: Nutriceutical formulation
  • Dietary Supplement: Nutriceutical formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
  • must be able to swallow pills

Exclusion Criteria:

  • known or suspected bipolar disorder
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01320527
05-1350, IIRG-08-91737
Yes
Ruth Remington, University of Massachusetts, Worcester
University of Massachusetts, Worcester
  • University of Massachusetts, Lowell
  • Alzheimer's Association
Principal Investigator: Ruth Remington, Ph.D. UMass Lowell, Lowell, MA 01854
University of Massachusetts, Worcester
April 2012

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