Clinical trial NCT01320527: A Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease
Official title: A Phase II Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Keywords: dietary supplement
cognition
mood
Alzheimer's disease
memory loss
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Lowell
name: Alzheimer's Association
First posted: 2011-03-22
Enrollment: 135
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: cognitive improvement or maintenance of cognitive performance
timeFrame: within 3 months of treatment
Secondary outcomes:
measure: behavioral/psychotic symptoms
timeFrame: within 3 months after initiation of treatment
Other outcomes:
Locations:
city: Naples
country: United States
facility: Naples Medical Center
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Ayer
country: United States
facility: Primary Care Cardiology Research
state: Massachusetts
city: Groton
country: United States
facility: Rivercourt Residences
state: Massachusetts
city: Lawrence
country: United States
facility: Mary Immaculate Residential
state: Massachusetts
city: Lowell
country: United States
facility: D'Youville Senior Care
state: Massachusetts
city: Mt. Arlington
country: United States
facility: Neurocognitive Institute
state: New Jersey
city: Layton
country: United States
facility: Advanced Memory Dynamics
state: Utah
Study officials:
affiliation: UMass Lowell, Lowell, MA 01854
name: Ruth Remington, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mota SI, Pita I, Aguas R, Tagorti S, Virmani A, Pereira FC, Rego AC. Mechanistic perspectives on differential mitochondrial-based neuroprotective effects of several carnitine forms in Alzheimer's disease in vitro model. Arch Toxicol. 2021 Aug;95(8):2769-2784. doi: 10.1007/s00204-021-03104-1. Epub 2021 Jun 24.
citation: Remington R, Bechtel C, Larsen D, Samar A, Page R, Morrell C, Shea TB. Maintenance of Cognitive Performance and Mood for Individuals with Alzheimer's Disease Following Consumption of a Nutraceutical Formulation: A One-Year, Open-Label Study. J Alzheimers Dis. 2016;51(4):991-5. doi: 10.3233/JAD-151098.
citation: Remington R, Bechtel C, Larsen D, Samar A, Doshanjh L, Fishman P, Luo Y, Smyers K, Page R, Morrell C, Shea TB. A Phase II Randomized Clinical Trial of a Nutritional Formulation for Cognition and Mood in Alzheimer's Disease. J Alzheimers Dis. 2015;45(2):395-405. doi: 10.3233/JAD-142499.