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| ID | Type | Description | Link |
|---|---|---|---|
| IIRG-08-91737 |
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| Name | Class |
|---|---|
| University of Massachusetts, Lowell | OTHER |
| Alzheimer's Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutriceutical formulation | Experimental | Nutritional supplement |
|
| Placebo 1 | Placebo Comparator |
| |
| Placebo 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutriceutical formulation | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Remington, Ph.D. | UMass Lowell, Lowell, MA 01854 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naples Medical Center | Naples | Florida | 34102 | United States | ||
| University of Maryland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34164711 | Derived | 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. | |
| 26967219 | Derived |
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| Placebo | Other | A mixture of 6 vitamins and nutriceuticals |
|
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Primary Care Cardiology Research | Ayer | Massachusetts | 01432 | United States |
| Rivercourt Residences | Groton | Massachusetts | 014590 | United States |
| Mary Immaculate Residential | Lawrence | Massachusetts | 01841 | United States |
| D'Youville Senior Care | Lowell | Massachusetts | 01854 | United States |
| Neurocognitive Institute | Mount Arlington | New Jersey | 07856 | United States |
| Advanced Memory Dynamics | Layton | Utah | 84040 | United States |
| 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. |
| 25589719 | Derived | 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. |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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