Comparison of Therapeutic Strategies With Cholinesterase Inhibitors (SOS TRIAL)
NCT ID: NCT03454646
Last Updated: 2023-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
1205 participants
INTERVENTIONAL
2024-06-01
2027-09-15
Brief Summary
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The investigators have shown that a good surrogate marker of survival without severe dementia would be an increase of ADAS Cog scale of more than six points (3). A post hoc reanalysis of the pivotal RCT with two CI showed that in mild to moderate patients, CI was associated with a 15% decrease of patients with a deterioration of ADAS-Cog of more than six points in six months. Thus at the beginning of dementia the real effect of CI might be more of delaying the cognitive and functional decline, than to improve the patients. The main objective of the SOS trial is to demonstrate that the benefit of CI at the early phase of dementia is the same as at the later phase.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group randomized for continuing treatment
Group who continues the cholinesterase inhibitors (CI). The treatment is one of the CI (donepezil, galantamine or rivastigmine) with market authorization and commercialized for more than 15 years in France. The choice of the treatment will be done by the specialist according to his habits; the specialist will monitor the treatment as usual.
All randomised patients will then be followed-up for two years with regular assessment of judgment criteria every 6 months.
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.
Group randomized for stopping treatment
Group who stops the CI. No placebo will be given, over 2 years All randomised patients will then be followed-up for two years with regular assessment of judgment criteria every 6 months.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of probable or possible AD, defined according to the NINCDS-ARDRA criteria
* Mild to moderate stage, defined by a MMSE score above 15 at the time of pre-inclusion
* Patients with indication to CI treatment
* Patients Naïve to CI treatment
* Patients aged 50 years or more
* Menopause or effective contraception (for women)
* Affiliated person or beneficiary of a social security scheme
* Patients with AD LTI (Long Term Illeness)
* Patients agree to participate, with free, informed and written consent signed by the patient and his caregiver
* Patients diagnosed with Lewy bodies disease, fronto-temporal dementia, or dementia from a cause other than Alzheimer Disease
* More severe stage of the disease, defined by a MMSE equal or below 15 at the time of inclusion
* Patients with contraindication to CI treatment
* Patients residing in an institution at the time of pré-inclusion or randomization
* Patients with a complete dependency for bathing and dressing at the time of pré-inclusion or randomization ( ADL de Katz, score 2/2 for the item "bathing" and/or "dressing")
* Patients under tutorship or curatorship, patients unable to express consent
* Patients with unstable severe general disease compromising the follow-up
* Patients without caregiver
* Patients included in another pharmacological trial
* Pregnant or breastfeeding women
Exclusion Criteria
* Patients with complete dependency for bathing and dressing at the randomization visit
* Patients residing in an institution at the randomization visit
50 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Locations
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CHU d'Amiens Centre Mémoire Ressources Recherche
Amiens, , France
CHU d'Angers Centre Mémoire Ressources Recherche
Angers, , France
CHU de Bastia Centre Mémoire Ressources Recherche
Bastia, , France
CHU de Besançon Centre Mémoire Ressources Recherche
Besançon, , France
CHU de Bordeaux - Service de Neurologie - Centre Mémoire Ressources Recherche -
Bordeaux, , France
CHRU Cavale Blanche Service de Gériatrie
Brest, , France
Service de Neuropsychologie Hôpital Neurologique Pierre Wertheimer
Bron, , France
CHU Côte de Nacre Service de neurologie et CMRR
Caen, , France
CHU de Clermont Ferrand Centre Mémoire Ressources Recherche
Clermont-Ferrand, , France
Hôpital Pasteur Service de Neurologie
Colmar, , France
CHU de Dijon- CMRR
Dijon, , France
Chu de Grenoble CMRR, Neurologie
Grenoble, , France
Hôpital Roger Salengro CMRR
Lille, , France
CHU Limoges Service de neurologie et CMRR
Limoges, , France
AP-HM
Marseille, , France
CHU Montpellier Hôpital Gui de Chauliac CMRR
Montpellier, , France
CHU de Nantes Clinique Neurologique Hôpital GR Laennec
Nantes, , France
Institut Claude Pompidou Centre Mémoire de Ressources et de Recherche
Nice, , France
APHP Hôpital Broca
Paris, , France
Hôpital Universitaire de la Pitié Salpêtrière Pavillon François Lhermitte
Paris, , France
APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal CMRR
Paris, , France
CHU La Milétrie Pôle de Gériatrie
Poitiers, , France
CHU Reims Hôpital Maison Blanche Court Séjour Gériatrique
Reims, , France
CHU de Rennes - Hôpital Pontchaillou / Service de Neurologie
Rennes, , France
CHU de Rouen Hôpital Charles Nicolle Service Neurologie
Rouen, , France
Chu de Saint-Etienne, CMRR
Saint-Etienne, , France
Chu de Strasbourg Hôpital Ka Robertsau Pôle de Gériatrie - CMRR
Strasbourg, , France
Centre de Recherche Clinique du Gérontopôle Cité de la Santé
Toulouse, , France
CHRU de Bretonneau Unité de gérontopsychiatrie
Tours, , France
CHU Nancy Service de Gériatrie-CMRR
Vandœuvre-lès-Nancy, , France
Hospice Civil de Lyon Hôpital des Charpennes
Villeurbanne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2016/27
Identifier Type: -
Identifier Source: org_study_id
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