A 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.
Mild Cognitive Impairment
Dietary Supplement: Nutriceutical formulation
|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|
- 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
- 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
|Study Start Date:||August 2008|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Nutriceutical formulation
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: MemoryXLDietary Supplement: Nutriceutical formulation
A mixture of 6 vitamins and nutriceuticals
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.
|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|
|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|
|Mt. Arlington, New Jersey, United States, 07856|
|United States, Utah|
|Advanced Memory Dynamics|
|Layton, Utah, United States, 84040|
|Principal Investigator:||Ruth Remington, Ph.D.||UMass Lowell, Lowell, MA 01854|