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

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ClinicalTrials.gov Identifier: NCT01320527
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : March 3, 2016
Sponsor:
Collaborators:
University of Massachusetts, Lowell
Alzheimer's Association
Information provided by (Responsible Party):
University of Massachusetts, Worcester

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Dietary Supplement: Nutriceutical formulation Other: Placebo Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease
Study Start Date : August 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nutriceutical formulation
Nutritional supplement
 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
Placebo Comparator: Placebo 1 Other: Placebo
A mixture of 6 vitamins and nutriceuticals
Placebo Comparator: Placebo 2 Other: Placebo
A mixture of 6 vitamins and nutriceuticals


Outcome Measures
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Primary Outcome Measures :
  1. cognitive improvement or maintenance of cognitive performance [ Time Frame: within 3 months of treatment ]
    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


Secondary Outcome Measures :
  1. behavioral/psychotic symptoms [ Time Frame: within 3 months after initiation of treatment ]
    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


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320527


Locations
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United States, Florida
Naples Medical Center
Naples, Florida, United States, 34102
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Primary Care Cardiology Research
Ayer, Massachusetts, United States, 01432
Rivercourt Residences
Groton, Massachusetts, United States, 014590
Mary Immaculate Residential
Lawrence, Massachusetts, United States, 01841
D'Youville Senior Care
Lowell, Massachusetts, United States, 01854
United States, New Jersey
Neurocognitive Institute
Mt. Arlington, New Jersey, United States, 07856
United States, Utah
Advanced Memory Dynamics
Layton, Utah, United States, 84040
Sponsors and Collaborators
University of Massachusetts, Worcester
University of Massachusetts, Lowell
Alzheimer's Association
Investigators
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Principal Investigator: Ruth Remington, Ph.D. UMass Lowell, Lowell, MA 01854
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01320527    
Other Study ID Numbers: 05-1350
IIRG-08-91737
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016
Keywords provided by University of Massachusetts, Worcester:
dietary supplement
cognition
mood
Alzheimer's disease
memory loss
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders