Methods of Treating Neurodevelopmental Diseases and Disorders

Patent metadata

Field	Value
Publication number	US-2017087110-A1
Application number	US-201515316110-A
Country	US
Kind code	A1
Filing date	Jun 5, 2015
Priority date	Jun 6, 2014
Publication date	Mar 30, 2017
Grant date	—

Abstract

The present invention relates generally to methods for the treatment and/or prophylaxis of neurological diseases and disorders involving administration of trans 10-HDA. In particular, the methods of the present invention are useful in the treatment and/or prophylaxis of acquired or progressive neurodevelopmental disorders and conditions in mammals. More particularly, methods are taught herein for the treatment and/or prophylaxis of diseases and disorders such as autism spectrum disorders.

First claim

1 . A method for the treatment and/or prophylaxis of a disease or disorder of the central nervous system, comprising administering to a mammal in need thereof an effective amount of trans 10-hydroxy-2-decenoic acid or a pharmaceutically acceptable salt thereof.

2 . The method according to claim 1 , wherein the disease or disorder is a neurodevelopmental disease or disorder.

3 . The method according to claim 1 or claim 2 wherein the disease or disorder is an acquired neurodevelopmental disease or disorder, a congenital neurodevelopmental disease or disorder, or a related condition.

4 . The method according to any one of claims 1 to 3 wherein the disease or disorder is an autism spectrum disorder.

5 . The method according to claim 4 wherein the autism spectrum disorder is selected from the group consisting of Autistic Disorder, Asperger's Disorder, Childhood Disintegrative Disorder and Pervasive Developmental Disorder-Not Otherwise Specified, and Rett syndrome.

6 . The method according to any one of claims 1 to 5 wherein the trans 10-hydroxy-2-decenoic acid or a pharmaceutically acceptable salt thereof is administered as a composition.

7 . The method according to claim 6 wherein the composition comprises royal jelly, an extract of royal jelly, or a composition derived from royal jelly.

8 . The method according to any one of claims 1 to 7 wherein the trans 10-hydroxy-2-decenoic acid or a pharmaceutically acceptable salt thereof is administered in a dosage in the range of 0.01 to 6000 mg/day, 0.1 to 5000 mg/day, 1 to 4000 mg/day, 10 to 3000 mg/day, 100 to 2000 mg/day, 500 to 1500 mg/day.

9 . The method according to any one of claims 1 to 8 wherein the trans 10-hydroxy-2-decenoic acid or a pharmaceutically acceptable salt thereof is administered in a dosage selected from 0.5 mg/day, 1 mg/day, 5 mg/day, 10 mg/day, 50 mg/day, 100 mg/day, 250 mg/day, 500 mg/day, 750 mg/day, 1000 mg/day, 1500 mg/day and 2000 mg/day.

10 . The method according to any one of claims 1 to 9 wherein the mammal is a human.

11 . A method for the treatment and/or prophylaxis of a disease or disorder of the central nervous system comprising administering to a mammal in need thereof an effective amount of royal jelly or an extract of royal jelly, wherein the royal jelly or extract thereof comprises trans 10-hydroxy-2-decenoic acid.

12 . Use of trans 10-hydroxy-2-decenoic acid or a pharmaceutically acceptable salt thereof in the preparation of a medicament for the treatment or prophylaxis of a neurodevelopmental disease or disorder.

13 . The use according to claim 12 wherein the disease or disorder is an autism spectrum disorders.

14 . The use according to claim 13 wherein the autism spectrum disorder is selected from the group consisting of Autistic Disorder, Asperger's Disorder, Childhood Disintegrative Disorder and Pervasive Developmental Disorder-Not Otherwise Specified, and Rett syndrome.

15 . The use of any one of claims 12 to 14 wherein the medicament comprises royal jelly, an extract of royal jelly, or is derived from royal jelly.

16 . Use of royal jelly or an extract of royal jelly in the preparation of a medicament for the treatment and/or prophylaxis of a neurological or neurodegenerative disease or disorder, wherein the royal jelly or extract thereof comprises trans 10-hydroxy-2-decenoic acid.

17 . Trans 10-hydroxy-2-decenoic acid or a pharmaceutically acceptable salt thereof for the treatment and/or prophylaxis of a neurodevelopmental disease or disorder.

18 . Trans 10-hydroxy-2-decenoic acid or a pharmaceutically acceptable salt thereof for use according to claim 17 wherein the disease or disorder is selected from the group consisting of Autistic Disorder, Asperger's Disorder, Childhood Disintegrative Disorder and Pervasive Developmental Disorder-Not Otherwise Specified, and Rett syndrome.

19 . Royal jelly or an extract of royal jelly for use in the treatment and/or prophylaxis of a neurodevelopmental disease or disorder, wherein the royal jelly or extract thereof comprises trans 10-hydroxy-2-decenoic acid.

20 . A composition comprising trans 10-hydroxy-2-decenoic acid or a pharmaceutically acceptable salt thereof for the treatment and/or prophylaxis of a neurodevelopmental disease or disorder.

21 . A composition according to claim 20 wherein the disease or disorder is selected from the group consisting of Autistic Disorder, Asperger's Disorder, Childhood Disintegrative Disorder and Pervasive Developmental Disorder-Not Otherwise Specified, and Rett syndrome.

22 . A therapeutic agent for use in the treatment and/or prophylaxis of a neurodevelopmental disease or disorder, wherein the agent is trans 10-hydroxy-2-decenoic acid or a pharmaceutically acceptable salt thereof.

23 . A therapeutic agent for use according to claim 22 wherein the disease or disorder is selected from the group consisting of Autistic Disorder, Asperger's Disorder, Childhood Disintegrative Disorder and Pervasive Developmental Disorder-Not Otherwise Specified, and Rett syndrome.

Assignees

• Univ Deakin
• The Florey Inst Of Neuroscience And Mental Health

Inventors

• Cheung Steve
• Boon Wah Chin

Classifications

• A61P25/18

  Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia · CPC title

• A61P25/28

  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 title

• A61P25/00

  Drugs for disorders of the nervous system · CPC title

• A61K31/201 Primary

  having one or two double bonds, e.g. oleic, linoleic acids · CPC title

• A61K35/644

  Beeswax; Propolis; Royal jelly; Honey · CPC title