Comparison of therapeutic strategies with Cholinesterase Inhibitors: stop or still (SOS) trial - SOSTrial

CHU de Bordeaux0 sites1,205 target enrollmentOctober 30, 2017

Overview

No summary available.

Registry

who.int

Start Date

October 30, 2017

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

CHU de Bordeaux

•ELIGIBILITY CRITERIA FOR THE OBSERVATIONAL PHASE: EVALUATED AT THE BEGINNING OF THE STUDY:
•a)New case of AD referring to a CMRR or memory clinics.
•b)Diagnosis of probable or possible AD, defined according to the NINCDS\-ARDRA criteria
•c)Mild to moderate stage, defined by a MMSE score equal or above 15 at the time of pre\-inclusion
•d)Patients with indication to CI treatment according to the 2011 HAS recommendations
•e)Patients naïve to CI treatment
•f)Patients aged 50 years or more
•g)Menopause or effective contraception (for women)
•h)Affiliated persons or beneficiary of a social security scheme
•i)Patients agree to participate, with free, informed and written consent signed by the patient and his caregiver

•ELIGIBILITY CRITERIA FOR THE OBSERVATIONAL PHASE: EVALUATED AT THE BEGINNING OF THE STUDY
•Non\-inclusion criteria
•a)Patients diagnosed with Lewy bodies disease, fronto\-temporal dementia, or dementia from a cause other than Alzheimer Disease
•b)More severe stage of the disease, defined by a MMSE below 15 at the time of pre\-inclusion
•c)Patients with contraindication to CI treatment
•d)Patients residing in an institution at the time of pre\-inclusion
•e)Patients with a complete dependency for bathing and dressing at the time of pre\-inclusion
•f)Patients under tutorship or curatorship, patients unable to express consent
•g)Patients with unstable severe general disease compromising the follow\-up
•h)Patients without caregiver