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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320527
• Other study ID #: 05-1350
• Secondary ID: IIRG-08-91737
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2011
• Last updated: March 2, 2016
• Start date: August 2008
• Est. completion date: April 2012

Study information

• Verified date: March 2016
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Dietary Supplement:
• Nutriceutical formulation
Two pills that collectively contain: folic acid (400µg), Vitamin B12 (6µg), Vitamin E (as alpha-tocopherol; 30 IU), S-adenosylmethionine (SAM; 400mg), N-acetyl cysteine (NAC; 600mg) and Acetyl-L-carnitine (ALCAR; 500mg). Taken once daily for duration of study (1 year).

Other:
• Placebo
A mixture of 6 vitamins and nutriceuticals

Locations

Country	Name	City	State
United States	Primary Care Cardiology Research	Ayer	Massachusetts
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	D'Youville Senior Care	Lowell	Massachusetts
United States	Neurocognitive Institute	Mt. Arlington	New Jersey
United States	Naples Medical Center	Naples	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Alzheimer's Association, University of Massachusetts, Lowell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive improvement or maintenance of cognitive performance	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	within 3 months of treatment	No
Secondary	behavioral/psychotic symptoms	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	within 3 months after initiation of treatment	No