Alzheimer disease
Conditions
Interventions
Trade Name: ARICEPT
Product Name: Donepezil
Product Code: Donepezil
Pharmaceutical Form: Coated tablet
INN or Proposed INN: DONEPEZIL
CAS Number: 340092662627
Current Sponsor code: DONEPEZIL
Concentr
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare two therapeutic strategies for the long-term risk (at 2 years) of dependency, institutionalization and death in mild to moderate AD patients who respond or do not respond to treatment after an initial 6-month period of CI treatment: continuation (still) or cessation (stop) of CI. This comparison will be performed separately for patients who respond to treatment and for those who do not respond to treatment at 6 months.;Secondary Objective: Secondary objectives: 1) To compare the same two therapeutic strategies on other outcomes: hospitalization rate, psychotropic drug consumption, MMSE score evolution, dependency to 5 basic activities of daily living (BADL), AGGIR scale, and separately on each criteria of the combined outcome (dependency, institutionalization and death). 2) To compare severe and cardiac adverse events between treatment arms. 3) To analyse the factors associated with initial response to CI at 6 months and with the long-term response at two years. ;Primary end point(s): The primary outcome is a combination of complete BADL dependency in bathing and dressing and/or institutionalization or death at 2 years after randomization. ;Timepoint(s) of evaluation of this end point: At 30 months ± 1 month after the inclusion visit ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are : - each of the components of the combined primary outcome analyzed separately, - global BADL dependency on 5 items, - AGGIR scale GIR 3, - MMSE score evolution, - number of hospitalizations, - psychotropic drug consumption, - severe and cardiac adverse events, - response to CI after 6 months of treatment. ;Timepoint(s) of evaluation of this end point: At 30 months ± 1 month after the inclusion visit ; At 3, 6, 12, 18, 24 months following the inclusion visit ; | — |
Countries
France
Contacts
Public ContactClinical Trials Manager
CHU de Bordeaux
Outcome results
None listed