A Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease
Primary Purpose
Alzheimer's Disease, Mild Cognitive Impairment
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nutriceutical formulation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring dietary supplement, cognition, mood, Alzheimer's disease, memory loss
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
Sites / Locations
- Naples Medical Center
- University of Maryland
- Primary Care Cardiology Research
- Rivercourt Residences
- Mary Immaculate Residential
- D'Youville Senior Care
- Neurocognitive Institute
- Advanced Memory Dynamics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Nutriceutical formulation
Placebo 1
Placebo 2
Arm Description
Nutritional supplement
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01320527
First Posted
March 21, 2011
Last Updated
March 2, 2016
Sponsor
University of Massachusetts, Worcester
Collaborators
University of Massachusetts, Lowell, Alzheimer's Association
1. Study Identification
Unique Protocol Identification Number
NCT01320527
Brief Title
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
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
University of Massachusetts, Lowell, Alzheimer's Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Mild Cognitive Impairment
Keywords
dietary supplement, cognition, mood, Alzheimer's disease, memory loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutriceutical formulation
Arm Type
Experimental
Arm Description
Nutritional supplement
Arm Title
Placebo 1
Arm Type
Placebo Comparator
Arm Title
Placebo 2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutriceutical formulation
Other Intervention Name(s)
MemoryXL
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A mixture of 6 vitamins and nutriceuticals
Primary Outcome Measure Information:
Title
cognitive improvement or maintenance of cognitive performance
Description
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
Time Frame
within 3 months of treatment
Secondary Outcome Measure Information:
Title
behavioral/psychotic symptoms
Description
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
Time Frame
within 3 months after initiation of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Remington, Ph.D.
Organizational Affiliation
UMass Lowell, Lowell, MA 01854
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naples Medical Center
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Primary Care Cardiology Research
City
Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
Country
United States
Facility Name
Rivercourt Residences
City
Groton
State/Province
Massachusetts
ZIP/Postal Code
014590
Country
United States
Facility Name
Mary Immaculate Residential
City
Lawrence
State/Province
Massachusetts
ZIP/Postal Code
01841
Country
United States
Facility Name
D'Youville Senior Care
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States
Facility Name
Neurocognitive Institute
City
Mt. Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Facility Name
Advanced Memory Dynamics
City
Layton
State/Province
Utah
ZIP/Postal Code
84040
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34164711
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.
Results Reference
derived
PubMed Identifier
26967219
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.
Results Reference
derived
PubMed Identifier
25589719
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.
Results Reference
derived
Learn more about this trial
A Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease
We'll reach out to this number within 24 hrs