# US 2019/0167624 A1 · Prevention and/or treatment of neurodegenerative disease

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- Number: US 2019/0167624 A1
- Document ID: US20190167624A1
- Status: Published application
- Kind: A1
- Application number: 15/980,083
- Filed: 2018-05-15
- Published: 2019-06-06
- Earliest claimed: 2017-12-04
- Assignees: Howard Foundation Holdings Limited
- Applicants: Howard Foundation Holdings Ltd
- Inventors: Alan Norman HOWARD; John NOLAN; Riona MULCAHY
- Web page: https://patentgrep.com/patent/US20190167624A1

## CPC

- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/047: having two or more hydroxy groups, e.g. sorbitol
- A61K 31/07: Retinol compounds, e.g. vitamin A (retinoic acids A61K31/203)
- A61K 31/201: having one or two double bonds, e.g. oleic, linoleic acids
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- 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

A method for the prevention and/or treatment of dementia in a human subject; the method comprising the step of administering an effective amount of a composition comprising at least one carotenoid selected from the group consisting of lutein, zeaxanthin and meso-zeaxanthin; and a composition comprising at least one omega-3 fatty acid.

## Claims

### Claim 1

A method for the treatment of Alzheimer's disease in a human subject exhibiting one or more symptoms of Alzheimer's disease, the method comprising the step of administering an effective amount of a composition comprising each of lutein, zeaxanthin and meso-zeaxanthin; and a composition comprising at least one omega-3 fatty acid, wherein the human subject to be treated has a mini mental state examination (MMSE) score of 25 or less.

### Claim 2

(canceled)

### Claim 3 (depends on 1)

The method according to claim 1, wherein a single administered composition comprises each of lutein, zeaxanthin, meso-zeaxanthin and at least one omega-3 fatty acid.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the said at least one omega-3 fatty acid is docosahexaenoic acid.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the said at least one omega-3 fatty acid is provided in the composition as a fish oil.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the said at least one omega-3 fatty acid comprises at least two omega-3 fatty acids.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the omega-3 fatty acid-containing composition comprises docosahexaenoic acid and eicosapentaenoic acid.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the said at least one omega-3 fatty acid is provided as the free acid, as a salt or as a trigylceride.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the salt comprises a monocation.

### Claim 10 (depends on 8)

The method according to claim 8, wherein the salt comprises a metal monocation.

### Claim 11

(canceled)

### Claim 12 (depends on 1)

The method according to claim 1, wherein the composition/s is/are administered orally to the subject at least three times a week.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the composition/s is/are administered to the subject daily.

### Claim 14 (depends on 1)

The method according to claim 1, wherein the composition/s is/are in unit dose form.

### Claim 15 (depends on 14)

The method according to claim 14, wherein each unit dose of composition comprises about 10 mg meso-zeaxanthin, about 10 mg lutein, about 2 mg zeaxanthin, and fish oil containing said at least one omega-3 fatty acid.

### Claim 16 (depends on 14)

The method according to claim 14, wherein each unit dose of composition comprises about 15 mg meso-zeaxanthin, about 5 mg lutein, about 1 mg zeaxanthin, and fish oil containing said at least one omega-3 fatty acid.

### Claim 17 (depends on 14)

The method according to claim 14, wherein each unit dose of the composition comprises between about 20 mg and about 2 grams of docosahexaenoic acid.

### Claim 18 (depends on 14)

The method according to claim 14, wherein each unit dose of composition comprises about 1 gram of fish oil containing said at least one omega-3 fatty acid.

### Claim 19 (depends on 1)

The method according to claim 1, wherein the composition/s further comprise one or more of the following: acidity regulators; anticaking agents selected from the group consisting of sodium aluminosilicate, calcium or magnesium carbonate, calcium silicate, sodium and potassium ferricyanide; antioxidants selected from the group consisting of vitamin E, vitamin C, and polyphenols; colorings selected from the group consisting of artificial colorings FD&C Blue No. 1, Blue No. 2, Green No. 3, Red No. 40, Red No. 3, Yellow No. 5 and Yellow No. 6; and natural colorings selected from the group consisting of caramel, annatto, cochineal, betanin, turmeric, saffron, and paprika; color retention agents; emulsifiers; flavours; flavour enhancers; preservatives; stabilizers; sweeteners and thickeners.

### Claim 20 (depends on 1)

The method according to claim 1, wherein the composition/s is/are in the form of a tablet or capsule.

### Claim 21 (depends on 1)

The method according to claim 1, wherein the subject consumes the composition/s on a daily basis over a period of at least 12 months.

### Claim 22

(canceled)

### Claim 23

(canceled)

### Claim 24 (depends on 1)

The method according to claim 1, comprising use of a composition consisting essentially of lutein, zeaxanthin, meso-zeaxanthin, at least one omega-3 polyunsaturated fatty acid or corresponding salt or triglyceride, and a diluent, carrier or excipient.

### Claim 25 (depends on 24)

The method according to claim 24, wherein the omega-3 polyunsaturated fatty acid or corresponding salt or triglyceride is DHA or a salt or triglyceride of DHA.

### Claim 26 (depends on 1)

The method according to claim 1, wherein the method comprises daily oral administration of a unit dose form composition comprising each of lutein; zeaxanthin; meso-zeaxanthin; and DHA and/or EPA, in preventing or retarding the progression of cognitive impairment in a subject already exhibiting one or more symptom of Alzheimer's disease prior to administration of the composition.
