Magnesium compositions and uses thereof for neurological disorders
Inventors
Assignees
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Publication Number
US-9616038-B2
Publication Date
2017-04-11
Expiration Date
Abstract
A composition for administration to a subject, such as oral administration to a subject, for example, has been provided. Such a composition may comprise at least one magnesium-counter ion compound. A magnesium-counter ion composition described herein may be useful for any of a variety of applications provided herein, such as maintaining, enhancing, and/or improving health, nutrition, and/or another condition of a subject, and/or cognitive, learning, and/or memory function. A magnesium-counter ion composition provided herein may be useful for administration to a subject presenting magnesium deficiency, mild cognitive impairment, Alzheimer's disease, attention deficit hyperactivity disorder, ALS, Parkinson's disease, diabetes, migraine, anxiety disorder, mood disorder, and/or hypertension. A kit, method, and other associated technology are also provided.
Core Innovation
The invention relates to orally treating a neurological disorder by administering a composition comprising magnesium threonate to a subject in need thereof. Magnesium threonate is characterized in relation to delivered elemental magnesium content, and the dosage form comprises at least 100 mg of magnesium threonate or delivers elemental magnesium in a defined range.
The disclosure addresses neurological disorders, including Alzheimer’s disease, and presents preclinical and translational evidence that magnesium supplementation, including magnesium threonate, improves cognitive and affective outcomes in Alzheimer’s disease models in a dose-linked manner. These improvements correlate with magnesium intake and plasma magnesium and are supported by behavioral measures including novel object recognition/short-term memory, open-field arena habituation, Morris water maze, and forced swim test measures such as immobility time.
The disclosure further addresses magnesium physiological status by presenting a basal blood magnesium after fasting approach as a more reliable indicator than post-meal peaks. It reports plasma/urine magnesium measurement using calmagite dye chemistry, includes comparative bioavailability data among magnesium compounds and magnesium-counter ion compositions, and discloses a mathematical multi-compartment framework linking extracellular magnesium concentration, urinary excretion, GFR, and basal magnesium.
In addition, the disclosure reports synaptic density preservation and less synapse loss in Alzheimer’s disease mouse models with magnesium threonate treatment, and describes increased serum magnesium, improved magnesium absorption/bioavailability with certain compositions in the presence of lactose or non-acidified milk components, and antidepressant effects using a forced swim test.
Claims Coverage
The independent claim is directed to an oral method of treating a neurological disorder using a dosage form comprising magnesium threonate, with three alternative elemental-magnesium constraints that define the scope. The claim set also centers on the dosage-form type and the claimed elemental magnesium delivery range.
Oral treatment of a neurological disorder with magnesium threonate
A method of treating a neurological disorder by orally administering to a subject in need thereof a composition comprising magnesium threonate in a dosage form.
Dosage form includes at least 100 mg magnesium threonate
The dosage form comprises at least 100 mg of magnesium threonate.
Elemental magnesium content range within magnesium threonate
The magnesium threonate comprises 30 mg to 1.5 g of elemental magnesium.
Elemental magnesium dose rate between 1.5 mg/kg/day and 18 mg/kg/day
The magnesium threonate is administered at a dose providing between 1.5 mg/kg/day to 18 mg/kg/day of elemental magnesium.
Overall, the claim coverage centers on oral administration of magnesium threonate to treat neurological disorders, with express quantitative constraints on elemental magnesium delivery either by minimum magnesium threonate amount in the dosage form, by elemental magnesium content in the magnesium threonate, or by an elemental magnesium dosing-rate range.
Stated Advantages
Improves cognitive and affective outcomes in Alzheimer’s disease models in a dose-linked manner.
Increases behavioral performance in novel object recognition/short-term memory and Morris water maze spatial memory measures.
Produces antidepressant-like effects in forced swim test, with reduced immobility time.
Preserves synaptic density and reduces synapse loss in Alzheimer’s disease mouse models.
Increases serum magnesium.
Provides a basal blood magnesium after fasting approach presented as more reliable than post-meal peaks for assessing magnesium physiological status.
Improves magnesium absorption/bioavailability with certain MCC formulations in the presence of lactose or non-acidified milk components.
Provides correlation of memory improvements with magnesium intake and plasma levels.
Increases Drosophila lifespan.
Documented Applications
Preclinical and translational assessment of magnesium supplementation, including magnesium threonate, for cognitive and affective outcomes in Alzheimer’s disease models.
Behavioral testing contexts including novel object recognition/short-term memory, open-field arena habituation, and Morris water maze to assess cognitive effects.
Forced swim test to assess antidepressant-like effects via immobility time.
Drosophila lifespan measurement as an organism-level benefit.
Bioanalytical determination of magnesium physiological status using basal blood magnesium after fasting, and plasma/urine magnesium measurement with calmagite Mg2+ chelating dye.
Use of a mathematical multi-compartment framework linking extracellular magnesium concentration, urinary excretion, GFR, and basal magnesium to guide targeting.
Treatment of neurological disorders, including cognitive/neurological disorders such as MCI, Alzheimer’s disease, dementia, depression, ADHD, ALS, and Parkinson’s disease.
Metabolic disorder use, including diabetes.
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