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CA2461248A1 - Use of d4 and 5-ht2a antagonists, inverse agonists or partial agonists - Google Patents

Use of d4 and 5-ht2a antagonists, inverse agonists or partial agonists Download PDF

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Publication number
CA2461248A1
CA2461248A1 CA 2461248 CA2461248A CA2461248A1 CA 2461248 A1 CA2461248 A1 CA 2461248A1 CA 2461248 CA2461248 CA 2461248 CA 2461248 A CA2461248 A CA 2461248A CA 2461248 A1 CA2461248 A1 CA 2461248A1
Authority
CA
Canada
Prior art keywords
towards
receptor
compound
dopamine
use according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA 2461248
Other languages
French (fr)
Other versions
CA2461248C (en
Inventor
Erik Buntinx
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
PharmaNeuroBoost NV
Original Assignee
B&B BEHEER NV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CA2451798A external-priority patent/CA2451798C/en
Application filed by B&B BEHEER NV filed Critical B&B BEHEER NV
Priority to CA 2461248 priority Critical patent/CA2461248C/en
Priority to CA 2487529 priority patent/CA2487529A1/en
Priority to SI200431439T priority patent/SI1708790T1/en
Priority to US10/580,962 priority patent/US8304431B2/en
Priority to DE602004026781T priority patent/DE602004026781D1/en
Priority to PCT/BE2004/000172 priority patent/WO2005053796A1/en
Priority to ES04801138T priority patent/ES2343962T3/en
Priority to EP04801138A priority patent/EP1708790B1/en
Priority to HR20100376T priority patent/HRP20100376T1/en
Priority to JP2006541759A priority patent/JP4571645B2/en
Priority to EP10159625A priority patent/EP2272514A1/en
Priority to DK04801138.1T priority patent/DK1708790T3/en
Priority to AT04801138T priority patent/ATE464901T1/en
Priority to PT04801138T priority patent/PT1708790E/en
Priority to RSP-2010/0323A priority patent/RS51331B/en
Priority to CA002547639A priority patent/CA2547639A1/en
Priority to PL04801138T priority patent/PL1708790T3/en
Publication of CA2461248A1 publication Critical patent/CA2461248A1/en
Publication of CA2461248C publication Critical patent/CA2461248C/en
Application granted granted Critical
Priority to CY20101100611T priority patent/CY1111017T1/en
Priority to US12/924,615 priority patent/US20110136865A1/en
Priority to US13/065,638 priority patent/US20110207776A1/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention relates to the use of compounds and compositions of compounds having D4 and/or 5-HT2A antagonistic, partial agonistic or inverse agonistic activity in combination with other compounds for treating neurodegenerative diseases or disorders, such as Parkinson disease and related cognitive diseases or disorders. The invention also relates to pharmaceutical compositions for administration to a patient diagnosed as having a neurodegenerative disease or disorder and/or a cognitive disease or disorder, said pharmaceutical composition containing (i) compounds having D4 antagonistic, partial agonistic or inverse agonistic activity and/or (ii) compounds having 5-HT2A
antagonistic, partial agonistic or inverse agonistic, and/or (iii) any known medicinal compound or compositions of said compounds in combination with another compound for treating said diseases or disorders to augment the therapeutic effect or to provide a faster onset of the therapeutic effect of said other compound.

Claims (40)

1. Use of a first compound for the preparation of a medicament for treating neurodegenerative diseases or disorders, characterized in that said compound is administered simultaneously with, separate from or prior to the administration of a second compound to augment the therapeutic effect or to provide a faster onset of the therapeutic effect of said second compound, further characterized in that said first compound has (i) a selective affinity for the Dopamine-4 (D4) receptor with a pKi value equal to or higher than 8 towards the D4 receptor and less than 8 towards other Dopamine receptors, and (ii) a selective affinity for the 5-HT2A receptor with a pKi value equal to or higher than 8 towards the 5-HT2A receptor and less than 8 towards other 5HT receptors.
2. Use according to claim 1, wherein said first compound is pipamperone.
3. Use according to claim 2, wherein said first compound is to be administered to a patient in a dose ranging between 5 and 15 mg of the active ingredient.
4. Use according to any of claims 1 to 3, wherein said neurodegenerative disease or disorder is Parkinson Disease.
5. Use according to any of claims 1 to 4, wherein said first compound is to be administered daily at least one day before administering said second compound.
6. Use according to any of claims 1 to 5, wherein said second compound is a dopamine receptor agonist.
7. Use according to claim 6, wherein said dopamine receptor agonist is chosen from the group consisting of amantadine, bromocriptine, cabergoline lisuride, pergolide, ropinirole and pramipexole, or a pro-drug or an active metabolite thereof, or a pharmaceutically acceptable salt thereof.
8. Use according to claim 7, wherein said dopamine receptor agonist is pergolide and is to be administered in a dose ranging between 0.5 and 10 mg of the active ingredient.
9. A pharmaceutical composition comprising (a) a compound having (i) a selective affinity for the Dopamine-4 (D4) receptor with a pKi value equal to or higher than 8 towards the D4 receptor and less than 8 towards other Dopamine receptors, and (ii) a selective affinity for the 5-HT2A
receptor with a pKi value equal to or higher than 8 towards the 5-HT2A receptor and less than 8 towards other 5HT receptors and (b) a dopamine receptor agonist, as a combined preparation for simultaneous, separate or sequential use for treating a neurodegenerative disease or disorder such as Parkinson Disease.
10. Use according to any of claims 1 to 5, wherein said second compound is levodopa associated with a decarboxylase inhibitor.
11. Use according to claim 10, wherein said levodopa/decarboxylase-inhibitor is chosen from the group consisting of levodopa/carbidopa and levodopa/benserazide, or a pro-drug or an active metabolite thereof, or a pharmaceutically acceptable salt thereof.
12. Use according to claim 12, wherein said levodopa/decarboxylase-inhibitor is levodopa/carbidopa and is to be administered in a dose ranging between 2000 mg/ 200 mg and 100 mg/ 10 mg of the active ingredients.
13. A pharmaceutical composition comprising (a) a compound having (i) a selective affinity for the Dopamine-4 (D4) receptor with a pKi value equal to or higher than 8 towards the D4 receptor and less than 8 towards other Dopamine receptors, and (ii) a selective affinity for the 5-HT2A
receptor with a pKi value equal to or higher than 8 towards the 5-HT2A receptor and less than 8 towards other 5HT receptors, and (b) a levodopa associated with a decarboxylase inhibitor, as a combined preparation for simultaneous, separate or sequential use for treating a neurodegenerative disease or disorder such as Parkinson Disease.
14. Use according to any of claims 1 to 5, wherein said second compound is a mono-amine oxidase B (MAO-B) inhibitor.
15. Use according to claim 14, wherein said second compound is selegilinehydrochloride or a pro-drug or an active metabolite thereof, or a pharmaceutically acceptable salt thereof.
16. Use according to claim 15, wherein said selegilinehydrochloride is to be administered in a dose ranging between 2 and 25 mg of the active ingredient.
17. A pharmaceutical composition comprising (a) a compound having (i) a selective affinity for the Dopamine-4 (D4) receptor with a pKi value equal to or higher than 8 towards the D4 receptor and less than 8 towards other Dopamine receptors, and (ii) a selective affinity for the 5-HT2A
receptor with a pKi value equal to or higher than 8 towards the 5-HT2A receptor and less than 8 towards other 5HT receptors and (b) a mono-amine oxidase B (MAO-B) inhibitor, as a combined preparation for simultaneous, separate or sequential use for treating a neurodegenerative disease or disorder such as Parkinson Disease.
18. Use of a composition for the preparation of a medicament for treating a neurodegenerative disease or disorder, characterized in that said composition is administered simultaneously with, separate from or prior to the administration of a third compound to augment the therapeutic effect or to provide a faster onset of the therapeutic effect of said third compound, further characterized in that said composition comprises a first compound having (i) a selective affinity for the D4 receptor with a pKi value equal to or higher than 8 towards the D4 receptor and less than 8 towards other Dopamine receptors, and a second compound having (ii) a selective affinity for the 5-HT2A receptor with a pKi value equal to or higher than 8 towards the 5-HT2A receptor and less than 8 towards other 5HT receptors.
19. Use according to claim 18, wherein said neurodegenerative disease or disorder is Parkinson Disease.
20. Use according to claim 18 or 19, wherein said first compound is chosen from the group consisting of, pipamperone, fananserin, L-745,870, PNU-1013876 and U-101387 or a pro-drug or a pharmaceutically acceptable salt thereof and wherein said second compound is chosen from the group comprising pipamperone, fananserin, ORG 5222, zotepine, olanzepine, clozapine, S16924, S18327, amperozide, serindole, MDL 100.907, tiospirone, fluspirilene, ocaperidone, risperidone, paliperidone and ziprasidone or a pro-drug or an active metabolite thereof, or a pharmaceutically acceptable salt thereof.
21. Use according to any of claims 18 to 20, wherein said composition is to be administered to a patient in a dose ranging between 0.5 µg and 2000 mg for each of the active ingredients.
22. Use according to any of claims 18 to 20, wherein said third compound is a dopamine receptor agonist.
23. Use according to claim 22, wherein said dopamine receptor agonist is chosen from the group consisting of amantadine, bromocriptine, cabergoline lisuride, pergolide, ropinirole and pramipexole, or a pro-drug or an active metabolite thereof, or a pharmaceutically acceptable salt thereof.
24. Use according to claim 23, wherein said dopamine receptor agonist is pergolide and is to be administered in a dose ranging between 0.5 and 10 mg of the active ingredient.
25. A pharmaceutical composition comprising (a) a compound having a selective affinity for the Dopamine-4 (D4) receptor with a pKi value equal to or higher than 8 towards the D4 receptor and less than 8 towards other Dopamine receptors, (b) a compound having a selective affinity for the 5-HT2A receptor with a pKi value equal to or higher than 8 towards the 5-HT2A receptor and less than 8 towards other 5HT
receptors, and (c) a dopamine receptor agonist, as a combined preparation for simultaneous, separate or sequential use for treating a neurodegenerative disease or disorder such as Parkinson Disease.
26. Use according to any of claims 18 to 20, wherein said third compound is levodopa associated with a decarboxylase inhibitor.
27. Use according to claim 26 wherein said levodopa/decarboxylase-inhibitor is chosen from the group comprising levodopa/carbidopa, levodopa/benserazide, or a pro-drug or an active metabolite thereof, or a pharmaceutically acceptable salt thereof.
28. Use according to claim 27, wherein said levodopa/decarboxylase-inhibitor is levodopa/carbidopa and is to be administered in a dose ranging between 2000 mg/ 200 mg and 100 mg/ 10 mg of the active ingredients.
29. A pharmaceutical composition comprising (a) a compound having a selective affinity for the Dopamine-4 (D4) receptor with a pKi value equal to or higher than 8 towards the D4 receptor and less than 8 towards other Dopamine receptors, and (b) a compound having a selective affinity for the 5-HT2A receptor with a pKi value equal to or higher than 8 towards the 5-HT2A receptor and less than 8 towards other 5HT
receptors, and (c) levodopa associated with a decarboxylase inhibitor, as a combined preparation for simultaneous, separate or sequential use for treating a neurodegenerative disease or disorder such as Parkinson Disease.
30. Use according to any of claims 18 to 20, wherein said third compound is a mono-amine oxidase B (MAO-B) inhibitor.
31. Use according to claim 30, wherein said mono-amine oxidase B (MAO-B) inhibitor is selegelinehydrochloride or a pro-drug or an active metabolite thereof, or a pharmaceutically acceptable salt thereof.
32. Use according to claim 31, wherein selegilinehydrochloride is to be administered in a dose ranging between 2 and 25 mg of the active ingredient.
33. A pharmaceutical composition comprising (a) a compound having a selective affinity for the Dopamine-4 (D4) receptor with a pKi value equal to or higher than 8 towards the D4 receptor and less than 8 towards other Dopamine receptors, and (b) a compound having selective affinity for the 5-HT2A receptor with a pKi value equal to or higher than 8 towards the 5-HT2A receptor and less than 8 towards other 5HT
receptors. and (c) a mono-amine oxidase B (MAO-B) inhibitor, as a combined preparation for simultaneous, separate or sequential use for treating a neurodegenerative disease or disorder such as Parkinson Disease.
34. Use of a compound as defined in any of claims 1 to 3, or of a composition as defined in claim 18, for the preparation of a medicament for treating a cognitive disease or disorder, characterized in that said compound or composition is administered simultaneously with, separate from or sequential to a cholinesterase inhibitor to augment the therapeutic effect or to provide a faster onset of the therapeutic effect of said cholinesterase inhibitor.
35. Use according to claim 34, wherein said disease or disorder is selected from the group consisting of delirium; dementia, such as Alzheimer Disease, substance-induced persisting dementia, vascular dementia, dementia due to a general medical condition chosen from the group comprising HIV disease, head trauma, Parkinson Disease, Huntington Disease, Pick Disease and Creutzfeldt-Jacob Disease; amnestic disorders due to a general medical condition or a substance-induced persisting amnestic disorder;
mild cognitive impairment disorder; and other cognitive disorders.
36. Use according to claim 34 or 35, wherein said cholinesterase inhibitor is chosen from the group consisting of donepezil, ENA-713, galantamine, memantine and tacrine, or a pro-drug or an active metabolite thereof, or a pharmaceutically acceptable salt thereof.
37. Use according to claim 36, wherein said cholinesterase inhibitor is galantamine and is to be administered in a dose ranging between 5 and 50 mg of the active ingredient.
38. A pharmaceutical composition comprising (a) a compound having (i) a selective affinity for the Dopamine-4 (D4) receptor with a pKi value equal to or higher than 8 towards the D4 receptor and less than 8 towards other Dopamine receptors, and (ii) a selective affinity for the 5-HT2A
receptor with a pKi value equal to or higher than 8 towards the 5-HT2A receptor and less than 8 towards other 5HT receptors, and (b) a cholinesterase inhibitor as a combined preparation for simultaneous, separate or sequential use for treating a cognitive disease or disorder.
39. A pharmaceutical composition comprising (a) a compound having a selective affinity for the Dopamine-4 (D4) receptor with a pKi value equal to or higher than 8 towards the D4 receptor and less than 8 towards other Dopamine receptors, and (b) a compound having a selective affinity for the 5-HT2A receptor with a pKi value equal to or higher than 8 towards the 5-HT2A receptor and less than 8 towards other 5HT
receptors, and (c) a cholinesterase inhibitor , as a combined preparation for simultaneous, separate or sequential use for treating a cognitive disease or disorder.
40. A pharmaceutical composition according to any of claims 9, 13, 17 or 38 wherein said compound having (i) a selective affinity for the Dopamine-4 (D4) receptor with a pKi value equal to or higher than 8 towards the D4 receptor and less than 8 towards other Dopamine receptors, and (ii) a selective affinity for the 5-HT2A receptor with a pKi value equal to or higher than 8 towards the 5-HT2A receptor and less than 8 towards other 5HT
receptors, is pipamperone and is present in the composition in a dose ranging between 5 and 15 mg of active ingredient, expressed as the daily dose to be administered to a patient in need thereof.
CA 2461248 2003-12-02 2004-03-18 Use of d4 and 5-ht2a antagonists, inverse agonists or partial agonists Expired - Fee Related CA2461248C (en)

Priority Applications (20)

Application Number Priority Date Filing Date Title
CA 2461248 CA2461248C (en) 2003-12-02 2004-03-18 Use of d4 and 5-ht2a antagonists, inverse agonists or partial agonists
CA 2487529 CA2487529A1 (en) 2003-12-02 2004-11-15 Use of d4 and 5-ht2a antagonists, inverse agonists or partial agonists
EP10159625A EP2272514A1 (en) 2003-12-02 2004-12-02 Use of low dose pipamperone and a second active compound in the treatment of neurodegenerative diseases
PT04801138T PT1708790E (en) 2003-12-02 2004-12-02 Use of pipamperone and a d2-receptor antagonist or a serotonin/dopamin antagonist for the treatment of psychotic disorders
DE602004026781T DE602004026781D1 (en) 2003-12-02 2004-12-02 USE OF PIPAMPERONE AND A D2 RECEPTOR ANTAGONIST OR A SEROTONINE / DOPAMINE ANTAGONIST
PCT/BE2004/000172 WO2005053796A1 (en) 2003-12-02 2004-12-02 Use of d4 and 5-ht2a antagonists, inverse agonists or partial agonists
ES04801138T ES2343962T3 (en) 2003-12-02 2004-12-02 USE OF PIPAMPERONE AND A D2 RECEIVER ANTAGONIST OR A SEROTONINE / DOPAMINE ANTAGONIST FOR THE TREATMENT OF PSYCHOTIC DISORDERS.
EP04801138A EP1708790B1 (en) 2003-12-02 2004-12-02 Use of pipamperone and a d2-receptor antagonist or a serotonin/dopamin antagonist for the treatment of psychotic disorders
HR20100376T HRP20100376T1 (en) 2003-12-02 2004-12-02 Use of pipamperone and a d2-receptor antagonist or a serotonin/dopamin antagonist for the treatment of psychotic disorders
JP2006541759A JP4571645B2 (en) 2003-12-02 2004-12-02 Use of D4 and 5-HT2A antagonists, inverse agonists or partial agonists
SI200431439T SI1708790T1 (en) 2003-12-02 2004-12-02 Use of pipamperone and a d2-receptor antagonist or a serotonin/dopamin antagonist for the treatment of psychotic disorders
DK04801138.1T DK1708790T3 (en) 2003-12-02 2004-12-02 Use of pipamperone by a D2 receptor antagonist or serotonin / dopamine antagonist in the treatment of psychotic disorders
AT04801138T ATE464901T1 (en) 2003-12-02 2004-12-02 USE OF PIPAMPERONE AND A D2 RECEPTOR ANTAGONIST OR A SEROTONIN/DOPAMINE ANTAGONIST FOR THE TREATMENT OF PSYCHOTIC DISORDERS
US10/580,962 US8304431B2 (en) 2003-12-02 2004-12-02 Use of D4 and 5-HT2A antagonists, inverse agonists or partial agonists
RSP-2010/0323A RS51331B (en) 2003-12-02 2004-12-02 USE OF PIPAMPERON AND D2-RECEPTOR ANTAGONISTS OR SEROTONIN / DOPAMINE ANTAGONISTS FOR THE TREATMENT OF PSYCHOTIC DISORDERS
CA002547639A CA2547639A1 (en) 2003-12-02 2004-12-02 Use of d4 and 5-ht2a antagonists, inverse agonists or partial agonists
PL04801138T PL1708790T3 (en) 2003-12-02 2004-12-02 Use of pipamperone and a d2-receptor antagonist or a serotonin/dopamin antagonist for the treatment of psychotic disorders
CY20101100611T CY1111017T1 (en) 2003-12-02 2010-07-05 USE OF PIPAMERONIS AND A D-2 COMPETITOR OR SEROTONIN / DOPAMIN COMPONENT OR COMPETITOR FOR THE TREATMENT OF PSYCHOLOGICAL DISORDERS
US12/924,615 US20110136865A1 (en) 2003-12-02 2010-09-30 Use of D4 and 5-HT2A antagonists, inverse agonists or partial agonists
US13/065,638 US20110207776A1 (en) 2003-12-02 2011-03-25 Use of D4 and 5-HT2A antagonists, inverse agonists or partial agonists

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
CA2,451,798 2003-12-02
CA2451798A CA2451798C (en) 2003-12-02 2003-12-02 Use of d4 and 5-ht2a antagonists, inverse agonists or partial agonists
EP04447001.1 2004-01-05
EP04447001 2004-01-05
CA 2461248 CA2461248C (en) 2003-12-02 2004-03-18 Use of d4 and 5-ht2a antagonists, inverse agonists or partial agonists

Publications (2)

Publication Number Publication Date
CA2461248A1 true CA2461248A1 (en) 2005-06-02
CA2461248C CA2461248C (en) 2009-12-22

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Application Number Title Priority Date Filing Date
CA 2461248 Expired - Fee Related CA2461248C (en) 2003-12-02 2004-03-18 Use of d4 and 5-ht2a antagonists, inverse agonists or partial agonists

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7855195B2 (en) 2003-12-02 2010-12-21 Pharmaneuroboost N.V. Method of treating mental disorders using D4 and 5-HT2A antagonists, inverse agonists or partial agonists
US7884096B2 (en) 2003-12-02 2011-02-08 Pharmaneuroboost N.V. Method of treating mental disorders using of D4 and 5-HT2A antagonists, inverse agonists or partial agonists
US8304431B2 (en) 2003-12-02 2012-11-06 Pharmaneuroboost N.V. Use of D4 and 5-HT2A antagonists, inverse agonists or partial agonists
WO2021140103A1 (en) * 2020-01-06 2021-07-15 Anima Cognitive disorder prevention and therapy

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7855195B2 (en) 2003-12-02 2010-12-21 Pharmaneuroboost N.V. Method of treating mental disorders using D4 and 5-HT2A antagonists, inverse agonists or partial agonists
US7884096B2 (en) 2003-12-02 2011-02-08 Pharmaneuroboost N.V. Method of treating mental disorders using of D4 and 5-HT2A antagonists, inverse agonists or partial agonists
US8304431B2 (en) 2003-12-02 2012-11-06 Pharmaneuroboost N.V. Use of D4 and 5-HT2A antagonists, inverse agonists or partial agonists
WO2021140103A1 (en) * 2020-01-06 2021-07-15 Anima Cognitive disorder prevention and therapy
WO2021139874A1 (en) * 2020-01-06 2021-07-15 Anima Cognitive disorder prevention and therapy
CN115279356A (en) * 2020-01-06 2022-11-01 安尤罗泰克Ip私人有限公司 Cognitive Impairment Prevention and Treatment
AU2021206771B2 (en) * 2020-01-06 2025-03-06 Aneurotech Bv Cognitive disorder prevention and therapy

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Publication number Publication date
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