Informations générales (source: ClinicalTrials.gov)
Comparison of Therapeutic Strategies With Cholinesterase Inhibitors: Stop or Still (SOS) Trial
Interventional
Phase 4
University Hospital, Bordeaux (Voir sur ClinicalTrials)
juin 2024
septembre 2027
29 juin 2024
Cholinesterase inhibitors (CI) remain the only drugs with a recognized efficacy in mild
to moderate Alzheimer's disease (AD) in spite of enormous research efforts. However,
these drugs presented as "symptomatic treatment" of AD are considered as having only a
weak effect on the course of AD. The reimbursement of these drugs is regularly challenged
due to the lack of evidence for the impact of these drugs on milestones stages of AD
evolution (survival without severe dementia, restriction in Basic Activities of Daily
Living - BADL) and on major consequences in public health (hospitalization and
institutionalization). The great majority of previous randomized controlled trials
conducted with CI have had a too short duration and the end points were limited to
cognition (ADAS Cog scale), IADL (Instrumental Activities of Daily Living) function and
Global Impression of Change. New evidences from the DOMINO trial (1) conducted in UK,
independently of the pharmaceutical industry, showed that the true effect of CI might be
more to avoid or to delay the cognitive or functional decline in AD than to improve
patients; the institutionalisation (2) was also delayed. However, this trial was
conducted in patients with moderate to severe AD, and the interest of the drugs at the
mild to moderate stage remains questionable.
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Broca-La Rochefoucauld-La Collégiale | Olivier HANON | Contact (sur clinicalTrials) | |||
| HU SAINT LOUIS SITE FERNAND WIDAL APHP | Claire PAQUET | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Recherche Clinique du Gérontopôle Cité de la Santé - Toulouse - France | Contact (sur clinicalTrials) | ||||
| CHRU Cavale Blanche Service de Gériatrie - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHRU de Bretonneau Unité de gérontopsychiatrie - 37000 - Tours - France | Thomas DESMIDT | Contact (sur clinicalTrials) | |||
| CHU Côte de Nacre Service de neurologie et CMRR - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU d'Amiens Centre Mémoire Ressources Recherche - 80054 - Amiens - France | Agnès DEVENDEVILLE | Contact (sur clinicalTrials) | |||
| CHU d'Angers Centre Mémoire Ressources Recherche - 49933 - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU de Besançon Centre Mémoire Ressources Recherche - 25030 - Besançon - France | Contact (sur clinicalTrials) | ||||
| CHU de Bordeaux - Service de Neurologie - Centre Mémoire Ressources Recherche - - 33076 - Bordeaux - France | Jean-François DARTIGUES | Contact (sur clinicalTrials) | |||
| CHU de Clermont Ferrand Centre Mémoire Ressources Recherche - 63000 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| CHU de Dijon- CMRR - 21679 - Dijon - France | Yannick BEJOT | Contact (sur clinicalTrials) | |||
| Chu de Grenoble CMRR, Neurologie - 38043 - Grenoble - France | Olivier MOREAUD | Contact (sur clinicalTrials) | |||
| CHU de Nantes Clinique Neurologique Hôpital GR Laennec - 44093 - Nantes - France | Claire BOUTOLEAU | Contact (sur clinicalTrials) | |||
| CHU de Rouen Hôpital Charles Nicolle Service Neurologie - 76031 - Rouen - France | David Wallon | Contact (sur clinicalTrials) | |||
| Chu de Strasbourg Hôpital Ka Robertsau Pôle de Gériatrie - CMRR - 67200 - Strasbourg - France | Frédéric BLANC | Contact (sur clinicalTrials) | |||
| CHU La Milétrie Pôle de Gériatrie - 86021 - Poitiers - France | Marc PACCALIN | Contact (sur clinicalTrials) | |||
| CHU Limoges Service de neurologie et CMRR - 87000 - Limoges - France | Leslie CARTZ-PIVER | Contact (sur clinicalTrials) | |||
| CHU Montpellier Hôpital Gui de Chauliac CMRR - 34295 - Montpellier - France | Audrey GABOREAU DE LOUSTAL | Contact (sur clinicalTrials) | |||
| CHU Nancy Service de Gériatrie-CMRR - 54511 - Vandoeuvre les nancy - France | Thérèse RIVASSEAU JONVAUX | Contact (sur clinicalTrials) | |||
| CHU Reims Hôpital Maison Blanche Court Séjour Gériatrique - 51092 - Reims - France | Jean-Luc NOVELLA | Contact (sur clinicalTrials) | |||
| Hôpital Pasteur Service de Neurologie - 68000 - Colmar - France | Contact (sur clinicalTrials) | ||||
| Hôpital Roger Salengro CMRR - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hospice Civil de Lyon Hôpital des Charpennes - 69100 - Villeurbanne - France | Pierre KROLAK SALMON | Contact (sur clinicalTrials) | |||
| Institut Claude Pompidou Centre Mémoire de Ressources et de Recherche - 06100 - Nice - France | Renaud David | Contact (sur clinicalTrials) | |||
| Service de Neuropsychologie Hôpital Neurologique Pierre Wertheimer - 69677 - Bron - France | Hélène MOLLION | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM - Marseille - France | Contact (sur clinicalTrials) | ||||
| CHU de Bastia Centre Mémoire Ressources Recherche - 20604 - Bastia - France | Georges RETTALI | Contact (sur clinicalTrials) | |||
| CHU de Rennes - Hôpital Pontchaillou / Service de Neurologie - 35033 - Rennes - France | Serge BELLIARD | Contact (sur clinicalTrials) | |||
| Chu de Saint-Etienne, CMRR - 42055 - Saint-Étienne - France | Isabelle ROUCH | Contact (sur clinicalTrials) | |||
| Hôpital Universitaire de la Pitié Salpêtrière Pavillon François Lhermitte - 75013 - Paris - France | Stéphane EPELBAUM | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- New case of AD referring to a CMRR or MC.
- 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
Non Inclusion Criteria:
- 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
- New case of AD referring to a CMRR or MC.
- 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
Non Inclusion Criteria:
- 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
- CI responder patients for whom the MMSE score remained stable or became higher after
6 months of treatment
- Patients with complete dependency for bathing and dressing at the randomization
visit
- Patients residing in an institution at the randomization visit