A Clinical Trial of a Vitamin/Nutriceutical Formulation for Alzheimer's Disease
NCT ID: NCT01320527
Last Updated: 2016-03-03
Study Results
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Basic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2008-08-31
2012-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Nutriceutical formulation
Nutritional 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).
Placebo 1
Placebo
A mixture of 6 vitamins and nutriceuticals
Placebo 2
Placebo
A mixture of 6 vitamins and nutriceuticals
Interventions
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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).
Placebo
A mixture of 6 vitamins and nutriceuticals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* must be able to swallow pills
Exclusion Criteria
40 Years
ALL
No
Sponsors
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University of Massachusetts, Lowell
OTHER
Alzheimer's Association
OTHER
University of Massachusetts, Worcester
OTHER
Responsible Party
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Principal Investigators
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Ruth Remington, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
UMass Lowell, Lowell, MA 01854
Locations
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Naples Medical Center
Naples, Florida, United States
University of Maryland
Baltimore, Maryland, United States
Primary Care Cardiology Research
Ayer, Massachusetts, United States
Rivercourt Residences
Groton, Massachusetts, United States
Mary Immaculate Residential
Lawrence, Massachusetts, United States
D'Youville Senior Care
Lowell, Massachusetts, United States
Neurocognitive Institute
Mount Arlington, New Jersey, United States
Advanced Memory Dynamics
Layton, Utah, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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IIRG-08-91737
Identifier Type: -
Identifier Source: secondary_id
05-1350
Identifier Type: -
Identifier Source: org_study_id
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