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

University of Massachusetts, Worcester

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Treatments: Other: Placebo; Dietary Supplement: Nutriceutical formulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01320527

IIRG-08-91737

05-1350

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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135 participants in 3 patient groups, including a placebo group

Nutriceutical formulation

Experimental group

Description:

Nutritional supplement

Treatment:

Dietary Supplement: Nutriceutical formulation

Placebo 1

Placebo Comparator group

Treatment:

Other: Placebo

Placebo 2

Placebo Comparator group

Treatment:

Other: Placebo