Status:
NOT_YET_RECRUITING
Comparison of Therapeutic Strategies With Cholinesterase Inhibitors (SOS TRIAL)
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Alzheimer Disease
Cholinesterase Inhibitors
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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 "s...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2027
Estimated Enrollment :
1205 Patients enrolled
Trial Details
Trial ID
NCT03454646
Start Date
June 1 2024
End Date
September 15 2027
Last Update
October 6 2023
Active Locations (31)
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1
CHU d'Amiens Centre Mémoire Ressources Recherche
Amiens, France, 80054
2
CHU d'Angers Centre Mémoire Ressources Recherche
Angers, France, 49933
3
CHU de Bastia Centre Mémoire Ressources Recherche
Bastia, France, 20604
4
CHU de Besançon Centre Mémoire Ressources Recherche
Besançon, France, 25030