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