A Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease Mild Cognitive Impairment |
Dietary Supplement: Nutriceutical formulation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase II Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease |
- cognitive improvement or maintenance of cognitive performance [ Time Frame: within 3 months of treatment ] [ Designated as safety issue: No ]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
- behavioral/psychotic symptoms [ Time Frame: within 3 months after initiation of treatment ] [ Designated as safety issue: No ]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
| Enrollment: | 135 |
| Study Start Date: | August 2008 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nutriceutical formulation
Nutritional supplement
|
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 Name: MemoryXL
Dietary Supplement: Nutriceutical formulation
A mixture of 6 vitamins and nutriceuticals
Other Names:
|
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| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Florida | |
| Naples Medical Center | |
| Naples, Florida, United States, 34102 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Primary Care Cardiology Research | |
| Ayer, Massachusetts, United States, 01432 | |
| Rivercourt Residences | |
| Groton, Massachusetts, United States, 014590 | |
| Mary Immaculate Residential | |
| Lawrence, Massachusetts, United States, 01841 | |
| D'Youville Senior Care | |
| Lowell, Massachusetts, United States, 01854 | |
| United States, New Jersey | |
| Neurocognitive Institute | |
| Mt. Arlington, New Jersey, United States, 07856 | |
| United States, Utah | |
| Advanced Memory Dynamics | |
| Layton, Utah, United States, 84040 | |
| Principal Investigator: | Ruth Remington, Ph.D. | UMass Lowell, Lowell, MA 01854 |
More Information
No publications provided
| Responsible Party: | Ruth Remington, Principal Investigator, University of Massachusetts, Worcester |
| ClinicalTrials.gov Identifier: | NCT01320527 History of Changes |
| Other Study ID Numbers: | 05-1350, IIRG-08-91737 |
| Study First Received: | March 21, 2011 |
| Last Updated: | April 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Massachusetts, Worcester:
|
dietary supplement cognition mood Alzheimer's disease memory loss |
Additional relevant MeSH terms:
|
Alzheimer Disease Cognition Disorders Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013