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

Phase 1

• Conditions: Alzheimer disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000569-61-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-30
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1205

Inclusion Criteria

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 RCT PHASE: EVALUATED AT 6 MONTHS:
Inclusion criteria for the RCT phase
a)Patients included in the observational phase of the SOS protocol
b)With an assessable 6-month response
c)Still under CI treatment at the time of randomization

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 205
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

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
i)Patients included in another pharmacological trial
j)Pregnant or breastfeeding women
ELIGIBILITY CRITERIA FOR THE RCT PHASE: EVALUATED AT 6 MONTHS:
Non-inclusion criteria for the RCT phase
a)Patients with complete dependency for bathing and dressing at the time of randomization
b)Patients residing in an institution at the time of randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified