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
  Purpose

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 Intervention Phase
Alzheimer's Disease
Mild Cognitive Impairment
Dietary Supplement: Nutriceutical formulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 135
Study Start Date: August 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Dietary Supplement: Nutriceutical formulation
A mixture of 6 vitamins and nutriceuticals
Other Names:
  • MemoryXL
  • GreatMind

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320527

Locations
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
Principal Investigator: Ruth Remington, Ph.D. UMass Lowell, Lowell, MA 01854
  More Information

No publications provided

Responsible Party: Ruth Remington, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01320527     History of Changes
Other Study ID Numbers: 05-1350, IIRG-08-91737
Study First Received: March 21, 2011
Last Updated: April 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
dietary supplement
cognition
mood
Alzheimer's disease
memory loss

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014