NCT03454646 · Phase 4 · NOT YET RECRUITING
Comparison of Therapeutic Strategies With Cholinesterase Inhibitors (SOS TRIAL)
This trial is comparing different strategies for using cholinesterase inhibitors — the standard memory drugs like donepezil, galantamine, and rivastigmine — in people with mild to moderate Alzheimer's. The main question is whether starting these drugs early delays serious cognitive and functional decline, not just temporarily improves symptoms. This is a Phase 4 trial, meaning the drugs are already approved and in use — researchers are refining how and when to use them best.
Eligibility criteria
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 Exclusion Criteria: * 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2023-10-06