Compositions and methods for neuroprotection and treatment of neurodegeneration

Inventors

Faulkner, Mark C. • Miller, Donald W. • Hatch, Grant M.

Assignees

Vireo Systems Inc

Abstract

Compositions for neuroprotection and treatment of neurodegeneration and methods of administering same. In particular, the present invention relates to compositions and methods for preventing or reducing neurodegeneration, such as neurodegeneration caused by Huntington's disease, including administering a daily dose of a composition including an effective amount of creatine hydrochloride to a patient in need thereof. The methods of the present invention allow for lower dosages of supplementation as compared to creatine monohydrate while retaining all of the desired biological effects of creatine supplementation.

Core Innovation

The patent describes a method for delaying the onset of neurodegeneration in a human by identifying a human carrying a mutation but lacking symptoms of neurodegeneration and administering a daily dose of a composition comprising an effective amount of creatine hydrochloride to the human. The approach is directed to humans prior to symptom onset, based on mutation status and symptom absence, and uses a daily creatine hydrochloride-containing composition as the administered treatment.

The patent further describes a method for delaying the progression of neurodegeneration by administering a daily dose of creatine hydrochloride to a human suffering from Huntington's disease, where the daily dose is about 0.5 grams to about 20 grams. The disclosed dosing framework includes further refinements in dependent claims, including narrower daily dose ranges, particular formulation types, and additional post-administration mitochondrial readouts.

In addition, the patent describes a method of treating neurodegeneration in a human carrying the huntingtin gene mutation by administering a daily dose of a composition comprising creatine hydrochloride and ethyl (α-guanido-methyl) ethanoate. The disclosed combination is associated with measurable biological effects in lymphoblast cells, including increased diacylglycerol acyltransferase 2 (DGAT2) activity after administration, and includes additional constraints on daily dose ranges and the amount of creatine hydrochloride in the composition.

Claims Coverage

The provided claims include three independent claims, each centered on administering a daily creatine hydrochloride-containing composition to a human in a neurodegeneration context. Collectively, the independent claims cover (i) delaying onset based on mutation carriage without symptoms, (ii) delaying progression in Huntington's disease, and (iii) treating neurodegeneration in humans carrying the huntingtin gene mutation using a specified combination composition.

Across the independent claims, the core claim coverage is the daily administration of creatine hydrochloride (alone or in combination) to delay onset or progression of neurodegeneration and to treat neurodegeneration in humans carrying the huntingtin gene mutation, including specified conditions of human selection (mutation status and/or disease state).

Stated Advantages

Documented Applications