Mild Cognitive Impairment Clinical Trial
Official title:
A Phase II 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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