Treatment and delay of outset of Parkinson's disease

• US 7,727,957 B2
• Filed: 10/31/2003
• Issued: 06/01/2010
• Est. Priority Date: 11/01/2002
• Status: Active Grant

• Current Assignee: Janssen Alzheimer Immunotherapy (Johnson & Johnson), Regents of the University of California (University of California)
• Original Assignee: Janssen Alzheimer Immunotherapy (Johnson & Johnson), Regents of the University of California (University of California)
• Inventors: Schenk, Dale B., Masliah, Eliezer
• Primary Examiner(s): Kolker; Daniel E.
• Application Number:
  US10/699,517
• Publication Number:
  US 20040136993A1
• Time in Patent Office: 2,405 Days
• Field of Search: 424/130.1, 424/141.1, 424/142.1, 424/178.1, 424/179.1, 424/185.1, 424/193.1
• US Class Current: 514/17.7
• CPC Class Codes: A61K 2039/55566 Emulsions, e.g. Freund's adjuvant, MF59
• CPC Class Codes: A61K 38/1709 from mammals
• CPC Class Codes: A61K 39/0007 Nervous system antigens; Prions
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 51/1078 the antibody being against an immunoglobulin, i.e. being an (anti)-anti-idiotypic antibody
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• 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
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention provides improved agents and methods for treatment of diseases associated with synucleinopathic diseases, including Lewy bodies of alpha-synuclein in the brain of a patient. Such methods entail administering agents that induce a beneficial immunogenic response against the Lewy body. The methods are particularly useful for prophylactic and therapeutic treatment of Parkinson'"'"'s disease.

Claims

1. A method of therapeutically treating a patient suffering from Parkinson'"'"'s disease, the method comprising

administering to the patient an effective regime of an agent and thereby therapeutically treating the disease;

wherein (i) the agent is Aβ

or an immunogenic fragment thereof and the agent is linked to a carrier that helps elicit an immune response to the agent or is administered with an adjuvant that augments an immune response to the agent, or (ii) the agent is an antibody to Aβ

.

2. The method of claim 1, wherein the agent is Aβ

or an immunogenic fragment thereof.

3. The method of claim 1, wherein the agent is an antibody to Aβ

.

4. The method of claim 1, wherein the agent is administered peripherally.

5. The method of claim 4, wherein the patient is free of clinical symptoms of a disease characterized by extracellular amyloid deposits.

6. The method of claim 1, wherein the effective regime comprises administering multiple dosages over a period of at least six months.

7. The method of claim 1, wherein the patient has a risk factor for the disease.

8. The method of claim 1, wherein the administering results in improvement in a sign or symptom of Parkinson'"'"'s disease.

9. The method of claim 1, wherein the administering improves motor characteristics of the patient.

10. The method of claim 1, further comprising monitoring a sign or symptom of Parkinson'"'"'s disease in the patient.

11. The method of claim 1, wherein the patient is free of Alzheimer'"'"'s disease.

12. The method of claim 11, wherein the patient is free of Alzheimer'"'"'s disease and has no genetic risk factors thereof.

13. The method of claim 1, wherein the patient is free of clinical symptoms of a disease characterized by extracellular amyloid deposits.

14. A method of therapeutically treating a patient suffering from Parkinson'"'"'s disease, comprising

administering to the patient an effective regime of a first agent and a second agent and thereby therapeutically treating the disease;

wherein (i) the first agent is alpha synuclein or an immunogenic fragment thereof, and the first agent is linked to a carrier that helps elicit an immune response to the first agent or is administered with an adjuvant that augments an immune response to the first agent, or (ii) the first agent is an antibody to alpha synuclein, and

wherein (i) the second agent is Aβ

or an immunogenic fragment thereof and the second agent is linked to a carrier that helps elicit an immune response to the second agent or is administered with an adjuvant that augments an immune response to the second agent, or (ii) the second agent is an antibody to Aβ

.

15. A method of reducing the risk, lessening the severity, or delaying the outset of disease in a patient having a known genetic risk of Parkinson'"'"'s disease, the method comprising

administering to the patient an effective regime of an agent and thereby reducing the risk, lessening the severity, or delaying the outset of the disease;

wherein (i) the agent is Aβ

or an immunogenic fragment thereof, and the agent is linked to a carrier that helps elicit an immune response to the agent or is administered with an adjuvant that augments an immune response to the agent, or (ii) the agent is an antibody to Aβ

.

16. The method of claim 15, wherein the agent is Aβ

or an immunogenic fragment thereof.

17. The method of claim 15, wherein the agent is an antibody to Aβ

.

18. The method of claim 15, wherein the agent is administered peripherally.

19. The method of claim 15, wherein the effective regime comprises administering multiple dosages over a period of at least six months.

20. The method of claim 15, wherein the patient is free of Alzheimer'"'"'s disease.

21. The method of claim 20, wherein the patient is free of Alzheimer'"'"'s disease and has no genetic risk factors thereof.

22. The method of claim 15, wherein the patient is free of clinical symptoms of a disease characterized by extracellular amyloid deposits.

23. A method of reducing the risk, lessening the severity, or delaying the outset of disease in a patient having a known genetic risk of Parkinson'"'"'s disease, comprising

administering to the patient an effective regime of a first agent and a second agent that induces an immunogenic response against Aβ

in the patient and thereby reducing the risk, lessening the severity, or delaying the outset of the disease;

wherein (i) the first agent is alpha synuclein or an immunogenic fragment thereof and the first agent is linked to a carrier that helps elicit an immune response to the first agent or is administered with an adjuvant that augments an immune response to the first agent, or (ii) the first agent is an antibody to alpha synuclein, and

wherein (i) the second agent is Aβ

or an immunogenic fragment thereof and the second agent is linked to a carrier that helps elicit an immune response to the second agent or is administered with an adjuvant that augments an immune response to the second agent, or (ii) the second agent is an antibody to Aβ

.

24. The method of claim 23, wherein the patient is free of clinical symptoms of a disease characterized by extracellular amyloid deposits.