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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease

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.

Detailed Summary:

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.


Sponsor: University of Massachusetts, Worcester

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: University of Massachusetts, Worcester

Dates:
Date Received: March 21, 2011
Date Started: August 2008
Date Completion:
Last Updated: March 2, 2016
Last Verified: March 2016