COCKTAIL FOR MODULATION OF ALZHEIMER'S DISEASE

• US 20090143433A1
• Filed: 12/01/2008
• Published: 06/04/2009
• Est. Priority Date: 12/01/2004
• Status: Abandoned Application

• Current Assignee: Concourse Health Sciences LLC
• Original Assignee: Concourse Health Sciences LLC
• Inventors: Hendrix, Curt
• Application Number:
  US12/325,842
• Publication Number:
  US 20090143433A1
• Time in Patent Office: Days
• US Class Current: 514/321
• 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 31/12 Ketones
• 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 31/353 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
• CPC Class Codes: A61K 31/4453 only substituted in position 1, e.g. propipocaine, diperodon
• CPC Class Codes: A61K 31/4525 containing a five-membered ring with oxygen as a ring hetero atom
• CPC Class Codes: A61K 36/67 Piperaceae (Pepper family), e.g. Jamaican pepper or kava
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: 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

Abstract

Formulations for the prevention and treatment of neurological diseases and cognitive deficiencies, i.e., Alzheimer'"'"'s Disease (AD), Parkinson'"'"'s Disease, amyotrophic lateral sclerosis, mild cognitive impairment and other types of dementia, comprise therapeutically effective amounts of curcumin, piperine, epigallocatechin-3-gallate (EGCG) and n-acetylcysteine. The combination addresses some or all of the pathways which can result in neurological deficiencies, degeneration and diseases.

Claims

1. A composition comprising curcumin, piperine, epigallocatechin-3-gallate and N-acetylcysteine in such amounts that the composition is therapeutically effective to treat a cognitive or neurological disorder in a patient.

2. The composition of claim 1, wherein the cognitive or neurological disorder is Alzheimer'"'"'s disease.

3. The composition of claim 1, wherein the cognitive or neurological disorder is amyotrophic lateral sclerosis, mild cognitive impairment, frontotemporal dementia with Parkinsonism linked to chromosome 17, Pick'"'"'s disease, progressive supranuclear palsy, and corticobasal degeneration.

4. The composition of claim 1, comprising at least about 75 mg curcumin, at least about 0.6 mg piperine, at least about 35 mg epigallocatechin-3-gallate, and at least about 32 mg N-acetylcysteine.

5. The composition of claim 4, further comprising one or more ingredients selected from the group consisting of:

α

-lipoic acid in an amount of at least about 19 mg;

vitamin B₁ in an amount of at least about 3 mg;

vitamin B₆ in an amount of at least about 6 mg;

vitamin B₁₂ in an amount of at least about 0.02 mg;

folate in an amount of at least about 0.04 mg;

vitamin C in an amount of at least about 24 mg;

and combinations thereof.

6. The composition of claim 4, further comprising:

α

-lipoic acid in an amount of at least about 19 mg;

vitamin B₁ in an amount of at least about 3 mg;

vitamin B₆ in an amount of at least about 6 mg;

vitamin B₁₂ in an amount of at least about 0.02 mg;

folate in an amount of at least about 0.04 mg; and

vitamin C in an amount of at least about 24 mg.

7. A method of treating a cognitive or neurological disorder in a patient, comprising administering to the patient a therapeutically effective amount of a composition comprising curcumin, piperine, epigallocatechin-3-gallate and N-acetylcysteine.

8. The method of claim 7, wherein the cognitive or neurological disorder is Alzheimer'"'"'s disease.

9. The method of claim 7, wherein the cognitive or neurological disorder is amyotrophic lateral sclerosis, mild cognitive impairment, frontotemporal dementia with Parkinsonism linked to chromosome 17, Pick'"'"'s disease, progressive supranuclear palsy, and corticobasal degeneration.

10. The method of claim 7, wherein the composition is administered in an amount sufficient to provide at least about 1.05 mg/kg patient body weight curcumin, at least about 0.01 mg/kg patient body weight piperine, at least about 0.5 mg/kg patient body weight epigallocatechin-3-gallate, and at least about 0.4 mg/kg patient body weight N-acetylcysteine.

11. The method of claim 10, wherein the composition is administered in unit dosage form comprising one unit dosage daily.

12. The method of claim 10, wherein the composition is administered in unit dosage form comprising more than one unit dosage daily.

13. The method of claim 10, wherein the composition is administered in an amount sufficient to provide from about 1.05 to about 85 mg/kg patient body weight curcumin, from about 0.01 to about 1.0 mg/kg patient body weight piperine, from about 0.5 to about 40 mg/kg patient body weight epigallocatechin-3-gallate, and about 0.4 to about 35 mg/kg patient body weight N-acetylcysteine.

14. The method of claim 10, wherein the composition is administered in an amount sufficient to provide from about 11.1 to about 111 mg/kg patient body weight curcumin, from about 0.09 to about 0.9 mg/kg patient body weight piperine, from about 5.5 to about 55 mg/kg patient body weight epigallocatechin-3-gallate, and about 4.7 to about 47 mg/kg patient body weight N-acetylcysteine.

15. The method of claim 10, wherein the composition is administered in an amount sufficient to provide from about 8.8 to about to about 13.4 mg/kg patient body weight curcumin, from about 0.09 to about 0.11 mg/kg patient body weight piperine, from about 4.4 to about 6.6 mg/kg patient body weight epigallocatechin-3-gallate, and about 3.7 to about 5.7 mg/kg patient body weight N-acetylcysteine.

16. The method of claim 10, wherein the composition is administered in an amount sufficient to provide from about 88.8 to about 133.2 mg/kg patient body weight curcumin, from about 0.7 to about 1.1 mg/kg patient body weight piperine, from about 44 to about 66 mg/kg patient body weight epigallocatechin-3-gallate, and about 37 to about 56.4 mg/kg patient body weight N-acetylcysteine.

17. The method of claim 10, wherein the composition further comprises one or more ingredients selected from the group consisting of α

-lipoic acid, vitamin B₁, vitamin B₆, vitamin B₁₂, folate, and vitamin C and is administered in an amount sufficient to provide as least one of;

α

-lipoic acid in an amount of at least about 0.2 mg/kg patient body weight;

vitamin B₁ in an amount of at least about 0.05 mg/kg patient body weight;

vitamin B₆ in an amount of at least about 0.09 mg/kg patient body weight;

vitamin B₁₂ in an amount of at least about 0.0002 mg/kg patient body weight;

folate in an amount of at least about 0.0006 mg/kg patient body weight;

or

vitamin C in an amount of at least about 0.35 mg/kg patient body weight.

18. The method of claim 10, wherein the composition further comprises α

-lipoic acid, vitamin B₁, vitamin B₆, vitamin B₁₂, folate, and vitamin C and is administered in an amount sufficient to provide;

α

-lipoic acid in an amount of at least about 0.2 mg/kg patient body weight;

vitamin B₁ in an amount of at least about 0.05 mg/kg patient body weight;

vitamin B₆ in an amount of at least about 0.09 mg/kg patient body weight;

vitamin B₁₂ in an amount of at least about 0.0002 mg/kg patient body weight;

folate in an amount of at least about 0.0006 mg/kg patient body weight; and

vitamin C in an amount of at least about 0.35 mg/kg patient body weight.

19. The method of claim 18, wherein the cognitive or neurological disorder is Alzheimer'"'"'s disease.

20. The method of claim 18, wherein the cognitive or neurological disorder is amyotrophic lateral sclerosis, mild cognitive impairment, frontotemporal dementia with Parkinsonism linked to chromosome 17, Pick'"'"'s disease, progressive supranuclear palsy, and corticobasal degeneration.

21. The method of claim 7, wherein treating the cognitive or neurological disorder comprises treating one or more adverse cognitive symptoms associated with the cognitive or neurological disorder.

22. The method of claim 21, wherein the cognitive symptom is selected from the group consisting of memory loss, personality change, agitation, disorientation, loss of coordination, inability to care for one'"'"'s self, and combinations thereof.

23. The method of claim 7, wherein treating the cognitive or neurological disorder comprises treating one or more adverse physiological symptoms associated with the cognitive or neurological disorder.

24. The method of claim 23, wherein the physiological symptom is selected from the group consisting of amyloid plaques, tau protein tangles, tau protein phosphorylation, microtubule destabilization, synaptic loss, and combinations thereof.

25. The method of claim 7, wherein treating the cognitive or neurological disorder comprises reducing a level of a low molecular weight oligomeric beta amyloid peptide in the patient.

26. The method of claim 25, wherein the oligomeric beta amyloid peptide is Aβ

*56.

27. The method of claim 25, wherein treating the cognitive or neurological disorder comprises reducing levels of low molecular weight oligomeric amyloid beta peptide by at least about 50% in the patient.