Over-the-counter vitamin/nutriceutical formulation that provides neuroprotection and maintains or improves cognitive performance in alzheimer's disease and normal aging

• US 20090110745A1
• Filed: 04/04/2008
• Published: 04/30/2009
• Est. Priority Date: 10/31/2007
• Status: Active Grant

• Current Assignee: University Of Massachusetts
• Original Assignee: University Of Massachusetts
• Inventors: Shea, Thomas B., Chan-Daniels, Amy Y.
• Granted Patent: US 8,597,640 B2
• Time in Patent Office: Days
• US Class Current: 424/523
• CPC Class Codes: A23L 33/10 using additives addition of substantially indigestible substances A23L33/21
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23L 33/175 Amino acids
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/322 having an effect on the health of the nervous system or on mental function
• CPC Class Codes: A23V 2250/0612 Carnitine
• CPC Class Codes: A23V 2250/0634 N-Acetyl-Cysteine
• CPC Class Codes: A23V 2250/312 S-adenosyl methionine
• CPC Class Codes: A23V 2250/7056 Vitamin B8 Folic acid
• CPC Class Codes: A23V 2250/706 Vitamin B12
• CPC Class Codes: A23V 2250/712 Vitamin E
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/205 Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
• CPC Class Codes: A61K 31/355 Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 31/525 Isoalloxazines, e.g. riboflavins, vitamin B2
• CPC Class Codes: A61K 31/7076 containing purines, e.g. adenosine, adenylic acid
• CPC Class Codes: A61K 35/60 Fish, e.g. seahorses; Fish eggs
• CPC Class Codes: A61K 36/16 Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
• CPC Class Codes: A61K 36/73 Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system

Abstract

The present invention provides methods for improving cognitive function, improving mood, and decreasing aggression in a normal adult subject, and in a subject having symptoms characteristic of a neurological disorder, by administration of a nutriceutical formulation of the invention to the subject. The invention additionally features methods of treating neurological disorders, depression, and aggression using nutriceutical formulations. Nutriceutical compositions and formulations for use in the methods of the invention, and kits containing nutriceutical compositions and formulations, are also provided.

Claims

1. A method of improving cognitive performance in a subject, comprising administering to the subject a formulation comprising folate, vitamin E, vitamin B12, N-acetyl cysteine, acetyl-L-carnitine, and S-adenosyl methionine.

2. The method of claim 1, wherein the subject is a normal adult.

3. The method of claim 1, wherein the subject suffers from a neurodegenerative disorder.

4. The method of claim 3, wherein the neurodegenerative disorder is selected from the group consisting of Alzheimer'"'"'s disease, Parkinson'"'"'s disease, or amyotrophic lateral sclerosis (ALS).

5. The method of claim 3, wherein the neurodegenerative disorder is early stage Alzheimer'"'"'s disease.

6. The method of claim 3, wherein the neurodegenerative disorder is mid/late stage Alzheimer'"'"'s disease.

7. The method of claim 1, wherein the formulation is administered orally.

22. The method of any one of claims 1, 8 and 15, wherein the formulation is administered as a unit dosage form.

23. The method of claim 22, wherein the formulation comprises folate in a dose of about 2-10 μ

g/kg, vitamin E in a dose of about 0.2-0.7 IU/kg, vitamin B12 in a dose of about 0.04-0.14 μ

g/kg, N-acetyl cysteine in a dose of about 4-14 mg/kg, acetyl-L-carnitine in a dose of about 3-12 mg/kg, or S-adenosyl methionine in a dose of about 3-10 mg/kg.

24. The method of claim 22, wherein the formulation further comprises a pharmaceutically acceptable carrier.

25. The method of any one of claims 1, 8 and 15, wherein the formulation consists essentially of 400 μ

g folate, 6 μ

g vitamin B12, 30 IU vitamin E, 400 mg S-adenosyl methionine, 600 mg N-acetyl cysteine, and 500 mg acetyl-L-carnitine.

26. The method of any one of claims 1, 8 and 15, wherein the formulation is administered in combination with one or more additional nutriceutical or pharmaceutical compositions.

27. The method of claim 26, wherein the additional composition is selected from the group consisting of donepezil, galantamine, rivastigmine, memantine, haloperidol, risperidone, olanzapine, clozapine, ziprasidone, quetiapine, fluoxetine hydrochloride, paroxetine, citalopram, sertraline hydrochloride, nortriptyline, alprazolam, lorazepam, oxazepam, and buspirone.

8. A method of reducing aggression in a subject, comprising administering to the subject a formulation comprising folate, vitamin E, vitamin B12, N-acetyl cysteine, acetyl-L-carnitine, and S-adenosyl methionine.

9. The method of claim 8, wherein the subject is a normal adult.

10. The method of claim 8, wherein the subject suffers from a neurodegenerative disorder.

11. The method of claim 10, wherein the neurodegenerative disorder is selected from the group consisting of Alzheimer'"'"'s disease, Parkinson'"'"'s disease, or amyotrophic lateral sclerosis (ALS).

12. The method of claim 10, wherein the neurodegenerative disorder is early stage Alzheimer'"'"'s disease.

13. The method of claim 10, wherein the neurodegenerative disorder is mid/late stage Alzheimer'"'"'s disease.

14. The method of claim 8, wherein the formulation is administered orally.

15. A method of improving mood in a subject, comprising administering to the subject a formulation comprising folate, vitamin E, vitamin B12, N-acetyl cysteine, acetyl-L-carnitine, and S-adenosyl methionine.

16. The method of claim 15, wherein the subject is a normal adult.

17. The method of claim 15, wherein the subject suffers from a neurodegenerative disorder.

18. The method of claim 17, wherein the neurodegenerative disorder is selected from the group consisting of Alzheimer'"'"'s disease, Parkinson'"'"'s disease, or amyotrophic lateral sclerosis (ALS).

19. The method of claim 17, wherein the neurodegenerative disorder is early stage Alzheimer'"'"'s disease.

20. The method of claim 17, wherein the neurodegenerative disorder is mid/late stage Alzheimer'"'"'s disease.

21. The method of claim 15, wherein the formulation is administered orally.

28. A composition comprising folate, vitamin E, vitamin B12, N-acetyl cysteine, acetyl-L-carnitine, and S-adenosyl methionine.

29. The composition of claim 28, comprising folate in a dose of about 2-10 μ

g/kg, vitamin E in a dose of about 0.2-0.7 IU/kg, vitamin B12 in a dose of about 0.04-0.14 μ

g/kg, N-acetyl cysteine in a dose of about 4-14 mg/kg, acetyl-L-carnitine in a dose of about 3-12 mg/kg, and S-adenosyl methionine in a dose of about 3-10 mg/kg.

31. The composition of claim 28, wherein the composition is a dietary supplement.

32. The composition of claim 28, wherein the composition is formulated for administration to a subject.

33. The composition of claim 28, wherein the composition is formulated for use as a food additive.

34. The composition of claim 28, wherein the composition is formulated as a liquid.

35. A kit comprising:

(a) the composition of claim 28; and

(b) instructions for administration to a subject.

36. A kit comprising:

(a) the composition of claim 28;

(b) one or more additional nutriceuticals; and

(c) instructions for administration to a subject.

37. The kit of claim 36, wherein the nutriceuticals are selected from the group consisting of ginko biloba, fish oil, and apple juice.

38. A kit comprising:

(a) the composition of claim 28; and

(b) a selection of cognitive exercises selected from the group consisting of sudoku puzzles and crossword puzzles.

39. A method of treating a neurodegenerative disorder in a subject, comprising administering a therapeutically effective amount of the composition of one of claim 28 to the subject, such that the disorder is treated.

40. The method of claim 39, wherein the neurodegenerative disorder is selected from the group consisting of Alzheimer'"'"'s disease, Parkinson'"'"'s disease, or amyotrophic lateral sclerosis (ALS).

41. The method of claim 39, wherein the neurodegenerative disorder is early stage Alzheimer'"'"'s disease.

42. The method of claim 39, wherein the neurodegenerative disorder is mid/late stage Alzheimer'"'"'s disease.

30. A composition consisting essentially of 400 μ

g folate, 6 μ

g vitamin B12, 30 IU vitamin E, 400 mg S-adenosyl methionine, 600 mg N-acetyl cysteine, and 500 mg acetyl-L-carnitine.