Comparison of Therapeutic Strategies With Cholinesterase Inhibitors (SOS TRIAL)

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

1,205

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

April 27, 2027

Study Completion Date

September 15, 2027

Conditions
Alzheimer DiseaseCholinesterase Inhibitors
Interventions
DRUG

cholinesterase inhibitors (CI) (donepezil, galantamine or rivastigmine)

"The choice of the treatment will be done by the specialist according to his habits; the specialist will monitor the treatment as usual. All the recruited patients will be treated by CI according to the recommendations of the French HAS and the clinician's habits to choose the type of CI and adjust the dosage. After a 6-month period under CI treatment, patients will be classified according to the evolution of the Mini Mental State Examination (MMSE) as non-responders or responders.~Responders patients will continue their treatment according to the habits of the clinician. Non-responder patients will be included in the RCT, with individual randomization in two groups: one group who stops the CI, one group who continues the CI. All randomized patients will then be followed-up for two years with regular assessment of judgment criteria every 6 months."

Trial Locations (31)

14033

CHU Côte de Nacre Service de neurologie et CMRR, Caen

20604

CHU de Bastia Centre Mémoire Ressources Recherche, Bastia

21679

CHU de Dijon- CMRR, Dijon

25030

CHU de Besançon Centre Mémoire Ressources Recherche, Besançon

29200

CHRU Cavale Blanche Service de Gériatrie, Brest

33076

CHU de Bordeaux - Service de Neurologie - Centre Mémoire Ressources Recherche -, Bordeaux

34295

CHU Montpellier Hôpital Gui de Chauliac CMRR, Montpellier

35033

CHU de Rennes - Hôpital Pontchaillou / Service de Neurologie, Rennes

37000

CHRU de Bretonneau Unité de gérontopsychiatrie, Tours

38043

Chu de Grenoble CMRR, Neurologie, Grenoble

42055

Chu de Saint-Etienne, CMRR, Saint-Etienne

44093

CHU de Nantes Clinique Neurologique Hôpital GR Laennec, Nantes

49933

CHU d'Angers Centre Mémoire Ressources Recherche, Angers

51092

CHU Reims Hôpital Maison Blanche Court Séjour Gériatrique, Reims

54511

CHU Nancy Service de Gériatrie-CMRR, Vandœuvre-lès-Nancy

59037

Hôpital Roger Salengro CMRR, Lille

63000

CHU de Clermont Ferrand Centre Mémoire Ressources Recherche, Clermont-Ferrand

67200

Chu de Strasbourg Hôpital Ka Robertsau Pôle de Gériatrie - CMRR, Strasbourg

68000

Hôpital Pasteur Service de Neurologie, Colmar

69100

Hospice Civil de Lyon Hôpital des Charpennes, Villeurbanne

69677

Service de Neuropsychologie Hôpital Neurologique Pierre Wertheimer, Bron

75013

APHP Hôpital Broca, Paris

Hôpital Universitaire de la Pitié Salpêtrière Pavillon François Lhermitte, Paris

75475

APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal CMRR, Paris

76031

CHU de Rouen Hôpital Charles Nicolle Service Neurologie, Rouen

80054

CHU d'Amiens Centre Mémoire Ressources Recherche, Amiens

86021

CHU La Milétrie Pôle de Gériatrie, Poitiers

87000

CHU Limoges Service de neurologie et CMRR, Limoges

Unknown

AP-HM, Marseille

Centre de Recherche Clinique du Gérontopôle Cité de la Santé, Toulouse

06100

Institut Claude Pompidou Centre Mémoire de Ressources et de Recherche, Nice

All Listed Sponsors
lead

University Hospital, Bordeaux

OTHER

NCT03454646 - Comparison of Therapeutic Strategies With Cholinesterase Inhibitors (SOS TRIAL) | Biotech Hunter | Biotech Hunter