Synergistic nutritional compositions for treating neurocognitive disorders

Inventors

SAMANT, Rajaram • Tongra, Rajendra Prasad

Assignees

Celagenex Research India Pvt Ltd

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Publication Number

US-12336972-B2

Patent

Publication Date

2025-06-24

Expiration Date


Abstract

The invention disclosed herein is related to novel synergistic nutritional compositions for treating neurocognitive disorders. Particularly, the invention provides a stable nutritional composition for treating neurocognitive disorders comprising an exogenous blend of magnesium L-threonate and homotaurine present in the weight ratio of 1:0.1 to 1:1, along with pharmaceutically acceptable excipients. Further, the present synergistic nutritional composition is useful for treating neurocognitive disorders such as Alzheimer's disease (AD), dementia, and Attention-deficit/hyperactivity disorder.

Core Innovation

The disclosed invention relates to synergistic neurocognitive nutraceutical compositions for treating neurocognitive disorders, including Alzheimer’s disease and dementia. The compositions comprise an exogenous blend and pharmaceutically acceptable excipients, where the exogenous blend consists of magnesium L-threonate (L-TAMS/MgLT) and homotaurine (HT) in defined weight ranges.

The invention addresses neurocognitive impairment by combining dual mechanisms attributed to magnesium L-threonate and homotaurine. Magnesium L-threonate is described as enhancing NMDAR signaling, increasing BDNF expression, and supporting synaptic density/plasticity, while also improving bioavailability and crossing the blood-brain barrier (BBB). Homotaurine is described as anti-amyloid by inhibiting Aβ fibrillogenesis/aggregates and as anti-neuroinflammatory, including effects related to hippocampal volume loss/damage.

Formulation embodiments are described, including active ranges and formulation characteristics such as crystallinity and excipient types, as well as oral dosage forms. In vivo mouse study data are reported for combined MgLT+HT versus disease control, including behavioral improvements in tests such as T-maze and pole climbing and biomarker changes including reduced tau, TNF-α, and IL-6, with increased BDNF and acetylcholine.

Claims Coverage

The independent claim provides coverage for a nutritional composition for treating neurocognitive disorder with two core inventive elements in the exogenous blend (magnesium L-threonate and homotaurine) at specified ranges, together with pharmaceutically acceptable excipients. Dependent claim coverage refines physical form, excipient selection with quantitative ranges, and oral administration.

Exogenous blend for treating neurocognitive disorder

The nutritional composition comprises an exogenous blend consisting of magnesium L-threonate in a range of 50 to 250 mg and homotaurine in a range of 25 to 50 mg.

Pharmaceutically acceptable excipients

The nutritional composition further comprises pharmaceutically acceptable excipients.

White crystalline magnesium L-threonate and homotaurine

The nutritional composition includes magnesium L-threonate and homotaurine in a white crystalline form.

Excipients with specified classes and weight-percentage ranges

The nutritional composition includes pharmaceutically acceptable excipients selected from diluent, binder, lubricant, glidant, additive, surfactant, stabilizer, antioxidant, and plasticizer, each present at stated weight-percentage ranges of the total composition.

Oral administration to a subject

The nutritional composition is administered orally to a subject.

Overall, the claim set centers on a nutritional composition for treating neurocognitive disorder with an exogenous blend of magnesium L-threonate and homotaurine at specified mg ranges, together with pharmaceutically acceptable excipients. Dependent claims narrow the composition to specific physical form (white crystalline), specify excipient classes with quantitative weight ranges, and limit use to oral administration.

Stated Advantages

Improved behavioral performance in in vivo mouse studies (T-maze and pole climbing).

Reduced biomarkers associated with disease conditions, including reduced tau, TNF-α, and IL-6.

Increased biomarkers associated with neurocognitive function, including increased BDNF and acetylcholine.

Synergistic targeting of neurocognitive mechanisms described as NMDAR signaling enhancement and BDNF expression (with synaptic density/plasticity support) alongside anti-amyloid and anti-neuroinflammatory effects.

Improved bioavailability and blood-brain barrier (BBB) crossing described for magnesium L-threonate.

Stability and purity are emphasized, including 24 months stability and accelerated-condition stability.

Documented Applications

Treating neurocognitive disorders, including Alzheimer’s disease and dementia.

Addressing neurocognitive disorders described in the partial content, including mild cognitive impairment (MCI), attention deficit/hyperactivity disorder (ADHD), and Parkinson’s disease.

Use in in vivo studies using mouse models described as scopolamine-induced memory deficit, with assessments including T-maze test and pole climbing test.

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