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

Phase 2

Completed

• Conditions: Alzheimer's Disease; Mild Cognitive Impairment
• Interventions: Other: Placebo; Dietary Supplement: Nutriceutical formulation

• Registration Number: NCT01320527
• Lead Sponsor: University of Massachusetts, Worcester

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 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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo 2	Placebo	-
Placebo 1	Placebo	-
Nutriceutical formulation	Nutriceutical formulation	Nutritional supplement

Primary Outcome Measures

Name	Time	Method
cognitive improvement or maintenance of cognitive performance	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

Secondary Outcome Measures

Name	Time	Method
behavioral/psychotic symptoms	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

Trial Locations

Locations (8)

Primary Care Cardiology Research; 🇺🇸 Ayer, Massachusetts, United States

Naples Medical Center; 🇺🇸 Naples, Florida, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Rivercourt Residences; 🇺🇸 Groton, Massachusetts, United States

Mary Immaculate Residential; 🇺🇸 Lawrence, Massachusetts, United States

Advanced Memory Dynamics; 🇺🇸 Layton, Utah, United States

Neurocognitive Institute; 🇺🇸 Mt. Arlington, New Jersey, United States

D'Youville Senior Care; 🇺🇸 Lowell, Massachusetts, United States