Over-the-counter vitamin/nutriceutical formulation that provides neuroprotection and maintains or improves cognitive performance in alzheimer's disease and normal aging

Inventors

Shea, Thomas B.Chan-Daniels, Amy Y.

Assignees

University of Massachusetts Lowell

Publication Number

US-8597640-B2

Publication Date

2013-12-03

Expiration Date

2028-04-04

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Abstract

The present invention provides methods for improving cognitive function, improving mood, and decreasing aggression in a normal adult subject, and in a subject having symptoms characteristic of a neurological disorder, by administration of a nutriceutical formulation of the invention to the subject. The invention additionally features methods of treating neurological disorders, depression, and aggression using nutriceutical formulations. Nutriceutical compositions and formulations for use in the methods of the invention, and kits containing nutriceutical compositions and formulations, are also provided.

Core Innovation

The invention provides novel nutriceutical formulations and methods for improving cognitive function, mood, and reducing aggression in both normal adults and individuals exhibiting symptoms of neurological disorders, such as Alzheimer's Disease. The formulations consist of a synergistic combination of six core components: folic acid, vitamin B12, vitamin E, S-adenosyl methionine, N-acetyl cysteine, and acetyl-L-carnitine. These are administered in defined amounts sufficient to produce statistically significant improvements on standard cognitive tests.

Current treatments for conditions like Alzheimer's Disease are costly, produce only temporary relief, and are associated with adverse side effects; moreover, there is no cure for Alzheimer's Disease. The invention addresses the growing need for an inexpensive, over-the-counter alternative that improves or maintains cognitive performance, mood, and daily function in individuals suffering from neurodegenerative diseases or normal aging. Nutrition-based approaches, such as the one described, are shown to be neuroprotective and beneficial in clinical and preclinical studies described in the document.

The core innovation lies in the identification and demonstration that these specific combinations of six agents exert a synergistic effect on neuronal health, outperforming individual components. Mechanistically, the formulations buffer neurons from oxidative or metabolic damage, maintain neurotransmitter production, and supply additional cellular energy, resulting in improved cognition, mood, and reduction in aggression or depression in both at-risk and affected populations.

Claims Coverage

The patent contains one independent claim covering a method with multiple inventive features.

Method of improving cognitive performance with a specific nutriceutical formulation

A method for improving cognitive performance in a human subject through administering a formulation that consists essentially of the following components: - 400 μg folate - 6 μg vitamin B12 - 30 IU vitamin E - 400 mg S-adenosyl methionine - 600 mg N-acetyl cysteine - 500 mg acetyl-L-carnitine This administration is in an amount sufficient to cause a statistically significant improvement in the subject's performance on one or more standard cognitive tests.

The claim covers the method of improving cognitive performance by administering a specific six-component nutriceutical formulation, defined by precise ingredient amounts, to human subjects.

Stated Advantages

The formulations improve cognitive function in normal adults and adults diagnosed with neurodegenerative disease, including Alzheimer's Disease.

They improve mood and behavior, reduce depression, and decrease aggression in both healthy individuals and those with neurological disorders.

The novel combinations provide synergistic neuroprotection superior to individual components, buffering neurons from oxidative attack, metabolic deficiencies, and supporting neurotransmitter production.

The formulations are safe, well-tolerated, and provide a cost-effective, over-the-counter alternative to current pharmacological treatments.

Documented Applications

Improving cognitive function in normal adult subjects.

Treating adults with symptoms of neurological disorders, including early and mid/late-stage Alzheimer's Disease.

Improving mood and reducing aggression, depression, and behavioral symptoms in normal adults and those with neurodegenerative disease.

Slowing or delaying the progression or onset of Alzheimer's Disease in at-risk individuals.

Maintaining the ability to perform daily activities in individuals with Alzheimer's Disease.

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