# US 10,245,245 B2 · Compositions and methods for neuroprotection and treatment of neurodegeneration

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- Number: US 10,245,245 B2
- Document ID: US10245245B2
- Status: Granted
- Kind: B2
- Application number: 15/133,501
- Filed: 2016-04-20
- Published: 2016-10-20
- Granted: 2019-04-02
- Earliest claimed: 2015-04-20
- Assignees: Vireo Systems, Inc.
- Applicants: Vireo Systems, Inc.
- Inventors: Mark C. Faulkner; Donald W. Miller; Grant M. Hatch
- Web page: https://patentgrep.com/patent/US10245245B2

## CPC

- A61K 31/197: the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid (carnitine A61K31/205)
- A61K 31/221: with compounds having an amino group, e.g. acetylcholine, acetylcarnitine
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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.

## Claims

### Claim 1

A method for preventing or reducing neurodegeneration in a human having the huntingtin gene mutation, comprising:
administering to the human an effective amount of a composition comprising creatine hydrochloride, wherein the effective amount comprises a daily dose of creatine hydrochloride of about 2 grams to about 12 grams.

### Claim 2 (depends on 1)

The method of claim 1, wherein the creatine hydrochloride is present in the composition in an amount of at least about 50 percent by weight of the composition.

### Claim 3 (depends on 1)

The method of claim 1, wherein the composition further comprises creatinine.

### Claim 4 (depends on 1)

The method of claim 1, wherein the composition is administered in the form of a pill, tablet, capsule, or gel capsule.

### Claim 5

A method for treating Huntington's disease, comprising:
administering an effective amount of creatine hydrochloride to a human suffering from Huntington's disease, wherein the effective amount comprises a daily dose of about 2 grams to about 12 grams.

### Claim 6 (depends on 5)

The method of claim 5, wherein the creatine hydrochloride is administered in combination with creatinine.

### Claim 7 (depends on 5)

The method of claim 5, wherein the creatine hydrochloride is administered in the form of a liquid, gel, or powder.

### Claim 8 (depends on 5)

The method of claim 5, wherein after the administering step, spare respiratory capacity of mitochondria in lymphoblast cells increases by at least about 60 percent.

### Claim 9 (depends on 5)

The method of claim 5, wherein after the administering step, total ATP turnover of mitochondria in lymphoblast cells increases by at least about 75 percent.

### Claim 10

A method of treating Huntington's disease or Parkinson's disease in a human, comprising:
administering to the human a daily dose of a composition comprising creatine hydrochloride, wherein the daily dose comprises about 2 grams to about 12 grams of creatine hydrochloride.

### Claim 11 (depends on 10)

The method of claim 10, wherein, after the step of administering, levels of diacylglycerol acyltransferase 2 activity in lymphoblast cells increases by at least about 10 percent.

### Claim 12 (depends on 10)

The method of claim 10, wherein the creatine hydrochloride is present in the composition in an amount of at least about 75 percent by weight.

### Claim 13 (depends on 10)

The method of claim 10, wherein the daily dose of the composition is administered as a nutritional or dietary supplement or as a functional food.

### Claim 14 (depends on 1)

The method of claim 1, wherein the creatine hydrochloride is administered in combination with at least one other compound selected from the group consisting of a homeopathic compound, a co-medication, a nutraceutical, a plant extract, a herbal preparation, a pharmaceutical, and combinations thereof.

### Claim 15 (depends on 1)

The method of claim 1, wherein the composition further comprises ethyl (α-guanido-methyl) ethanoate.

### Claim 16 (depends on 1)

The method of claim 1, wherein the creatine hydrochloride is present in the composition in an amount of at least about 75 percent by weight of the composition.

### Claim 17 (depends on 1)

The method of claim 1, wherein the creatine hydrochloride is present in the composition in an amount of at least about 90 percent by weight of the composition.

### Claim 18 (depends on 10)

The method of claim 10, wherein the creatine hydrochloride is present in the composition in an amount of at least about 90 percent by weight of the composition.
