Comparison of Therapeutic Strategies With Cholinesterase Inhibitors (SOS TRIAL)

October 5, 2023 updated by: University Hospital, Bordeaux

Comparison of Therapeutic Strategies With Cholinesterase Inhibitors: Stop or Still (SOS) Trial

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 "symptomatic treatment" of AD are considered as having only a weak effect on the course of AD. The reimbursement of these drugs is regularly challenged due to the lack of evidence for the impact of these drugs on milestones stages of AD evolution (survival without severe dementia, restriction in Basic Activities of Daily Living - BADL) and on major consequences in public health (hospitalization and institutionalization). The great majority of previous randomized controlled trials conducted with CI have had a too short duration and the end points were limited to cognition (ADAS Cog scale), IADL (Instrumental Activities of Daily Living) function and Global Impression of Change. New evidences from the DOMINO trial (1) conducted in UK, independently of the pharmaceutical industry, showed that the true effect of CI might be more to avoid or to delay the cognitive or functional decline in AD than to improve patients; the institutionalisation (2) was also delayed. However, this trial was conducted in patients with moderate to severe AD, and the interest of the drugs at the mild to moderate stage remains questionable.

The investigators have shown that a good surrogate marker of survival without severe dementia would be an increase of ADAS Cog scale of more than six points (3). A post hoc reanalysis of the pivotal RCT with two CI showed that in mild to moderate patients, CI was associated with a 15% decrease of patients with a deterioration of ADAS-Cog of more than six points in six months. Thus at the beginning of dementia the real effect of CI might be more of delaying the cognitive and functional decline, than to improve the patients. The main objective of the SOS trial is to demonstrate that the benefit of CI at the early phase of dementia is the same as at the later phase.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1205

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
      • Angers, France, 49933
        • CHU d'Angers Centre Mémoire Ressources Recherche
      • Bastia, France, 20604
        • CHU de Bastia Centre Mémoire Ressources Recherche
        • Contact:
      • Besançon, France, 25030
        • CHU de Besançon Centre Mémoire Ressources Recherche
      • Bordeaux, France, 33076
      • Brest, France, 29200
        • CHRU Cavale Blanche Service de Gériatrie
      • Bron, France, 69677
        • Service de Neuropsychologie Hôpital Neurologique Pierre Wertheimer
        • Contact:
      • Caen, France, 14033
        • CHU Côte de Nacre Service de neurologie et CMRR
      • Clermont-Ferrand, France, 63000
        • CHU de Clermont Ferrand Centre Mémoire Ressources Recherche
      • Colmar, France, 68000
        • Hôpital Pasteur Service de Neurologie
      • Dijon, France, 21679
      • Grenoble, France, 38043
        • Chu de Grenoble CMRR, Neurologie
        • Contact:
      • Lille, France, 59037
        • Hôpital Roger Salengro CMRR
      • Limoges, France, 87000
        • CHU Limoges Service de neurologie et CMRR
        • Contact:
      • Marseille, France
        • AP-HM
      • Montpellier, France, 34295
        • CHU Montpellier Hôpital Gui de Chauliac CMRR
        • Contact:
      • Nantes, France, 44093
      • Nice, France, 06100
        • Institut Claude Pompidou Centre Mémoire de Ressources et de Recherche
        • Contact:
      • Paris, France, 75013
      • Paris, France, 75013
        • Hôpital Universitaire de la Pitié Salpêtrière Pavillon François Lhermitte
        • Contact:
      • Paris, France, 75475
        • APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal CMRR
        • Contact:
      • Poitiers, France, 86021
      • Reims, France, 51092
        • CHU Reims Hôpital Maison Blanche Court Séjour Gériatrique
        • Contact:
      • Rennes, France, 35033
        • CHU de Rennes - Hôpital Pontchaillou / Service de Neurologie
        • Contact:
      • Rouen, France, 76031
        • CHU de Rouen Hôpital Charles Nicolle Service Neurologie
        • Contact:
      • Saint-Étienne, France, 42055
      • Strasbourg, France, 67200
      • Toulouse, France
        • Centre de Recherche Clinique du Gérontopôle Cité de la Santé
      • Tours, France, 37000
        • CHRU de Bretonneau Unité de gérontopsychiatrie
        • Contact:
      • Vandoeuvre les nancy, France, 54511
        • CHU Nancy Service de Gériatrie-CMRR
        • Contact:
      • Villeurbanne, France, 69100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group randomized for continuing treatment

Group who continues the cholinesterase inhibitors (CI). The treatment is one of the CI (donepezil, galantamine or rivastigmine) with market authorization and commercialized for more than 15 years in France. The choice of the treatment will be done by the specialist according to his habits; the specialist will monitor the treatment as usual.

All randomised patients will then be followed-up for two years with regular assessment of judgment criteria every 6 months.
Drug: cholinesterase inhibitors (CI) (donepezil, galantamine or rivastigmine)

The choice of the treatment will be done by the specialist according to his habits; the specialist will monitor the treatment as usual. All the recruited patients will be treated by CI according to the recommendations of the French HAS and the clinician's habits to choose the type of CI and adjust the dosage. After a 6-month period under CI treatment, patients will be classified according to the evolution of the Mini Mental State Examination (MMSE) as "non-responders" or responders.

Responders patients will continue their treatment according to the habits of the clinician. Non-responder patients will be included in the RCT, with individual randomization in two groups: one group who stops the CI, one group who continues the CI. All randomized patients will then be followed-up for two years with regular assessment of judgment criteria every 6 months.
No Intervention: Group randomized for stopping treatment
Group who stops the CI. No placebo will be given, over 2 years All randomised patients will then be followed-up for two years with regular assessment of judgment criteria every 6 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary outcome is a combination of complete BADL dependency in bathing and dressing and/or institutionalization or death at 2 years after randomization.
Time Frame: at 30 months after patient's inclusion

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 30 months after patient's inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at inclusion

Each of the components of the combined primary outcome, as defined above, analyzed separately.

As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at inclusion
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at 6 months

Each of the components of the combined primary outcome, as defined above, analyzed separately.

As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at 6 months
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at 12 months
Each of the components of the combined primary outcome, as defined above, analyzed separately As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at 12 months
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at 18 months
Each of the components of the combined primary outcome, as defined above, analyzed separately As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at 18 months
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at 24 months
Each of the components of the combined primary outcome, as defined above, analyzed separately As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at 24 months
BADL dependency will be evaluated by the clinician using the BADL scale from Katz [17].
Time Frame: at 30 months
Each of the components of the combined primary outcome, as defined above, analyzed separately As previously demonstrated, bathing and dressing are the first ADL losses, also defined by Katz et al. as the thresholds of disability [17] [18]. A total limitation in bathing and dressing will be considered (each item is coded from 0 - no limitation, to 2 - total limitation).
at 30 months
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at inclusion

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at inclusion
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at 6 months

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 6 months
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at 12 months

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 12 months
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at 18 months

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 18 months
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at 24 months

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 24 months
Combination of complete BADL dependency in bathing and dressing and/or institutionalization or death
Time Frame: at 30 months

Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.

Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.

For dependency in bathing and dressing, although it could be considered as less objective, we choose a level of total dependency, easy to assess with very low risk of misinterpretation.
at 30 months
Institutionalization with date of entry
Time Frame: at inclusion
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at inclusion
Institutionalization with date of entry
Time Frame: at 6 months
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at 6 months
Institutionalization with date of entry
Time Frame: at 12 months
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at 12 months
Institutionalization with date of entry
Time Frame: at 18 months
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at 18 months
Institutionalization with date of entry
Time Frame: at 24 months
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at 24 months
Institutionalization with date of entry
Time Frame: at 30 months
Institutionalization with date of entry will be assessed by specialist at each follow-up time every 6 months. For patients not coming to the memory consultation, caregiver (formal and/or informal) and/or the general practitioner will be systematically contacted to obtain the information.
at 30 months
Death and date of death
Time Frame: at inclusion
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at inclusion
Death and date of death
Time Frame: at 6 months
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at 6 months
Death and date of death
Time Frame: at 12 months
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at 12 months
Death and date of death
Time Frame: at 18 months
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at 18 months
Death and date of death
Time Frame: at 24 months
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at 24 months
Death and date of death
Time Frame: at 30 months
Death and date of death will be assessed by contacting proxy or general practitioner. In case of lack of information the birth City Hall will be contacted to assess the vital status.
at 30 months
the ADL scale
Time Frame: at inclusion

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10 If the patient has a result of 2 at bathing and or dressing he can't be included at T0.
at inclusion
the ADL scale
Time Frame: at 6 months

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10 If the patient has a result of 2 at bathing and or dressing he can't be randomized at T6M
at 6 months
the ADL scale
Time Frame: at 12 months

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10
at 12 months
the ADL scale
Time Frame: at 18 months

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10
at 18 months
the ADL scale
Time Frame: at 24 months

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10
at 24 months
the ADL scale
Time Frame: at 30 months

ADL DE KATZ BATHING :└-┘/2 0 bathes self completely

  1. needs help in bathing only one part of the body
  2. needs help with bathing more than one part of the body or not bathed DRESSING :└-┘ /2

0 gets clothes and gets completely dressed without assistance

1 gets clothes and gets dressed without assistance, except for assistance in tying shoes 2 receives assistance in getting clothes or in getting dressed, or stays partly or completely undressed TOILETING :└-┘/2 0 toileting without assistance (may use cane, walker, or wheelchair)

1 receives assistance 2 doesn't go to room termed " toilet ". TRANSFER:└-┘/2 0 transfer without assistance (may be using cane or walker)

  1. transfer with assistance
  2. doesn't get out of bed. FEEDING :└-┘/2

0 feeding without help

  1. need help cutting meat or buttering bread
  2. needs total help or requires parenteral feeding. TOTAL : └-┴-┘/10
at 30 months
the MMSE score
Time Frame: at inclusion
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at inclusion
the MMSE score
Time Frame: at 6 months
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at 6 months
the MMSE score
Time Frame: at 12 months
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at 12 months
the MMSE score
Time Frame: at 18 months
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at 18 months
the MMSE score
Time Frame: at 24 months
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at 24 months
the MMSE score
Time Frame: at 30 months
The MMSE score will be assessed by the clinician, the psychologist or the speech therapist according to the habits of the center, using the French version of the MMSE (GRECO version)
at 30 months
the number of hospitalizations
Time Frame: at inclusion
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at inclusion
the number of hospitalizations
Time Frame: at 6 months
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at 6 months
the number of hospitalizations
Time Frame: at 12 months
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at 12 months
the number of hospitalizations
Time Frame: at 18 months
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at 18 months
the number of hospitalizations
Time Frame: at 24 months
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at 24 months
the number of hospitalizations
Time Frame: at 30 months
The number of hospitalizations will be assessed using standardized questionnaire, with date (month/year) and duration of hospitalization;
at 30 months
Pharmacologie treatments consumed by the patient
Time Frame: at inclusion
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at inclusion
Pharmacologie treatments consumed by the patient
Time Frame: at 6 months
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at 6 months
Pharmacologie treatments consumed by the patient
Time Frame: at 12 months
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at 12 months
Pharmacologie treatments consumed by the patient
Time Frame: at 18 months
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at 18 months
Pharmacologie treatments consumed by the patient
Time Frame: at 24 months
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at 24 months
Pharmacologie treatments consumed by the patient
Time Frame: at 30 months
All the pharmacologie treatments consumed by the patient will be assessed, allowing to assess psychotropic drug consumption.
at 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2016/27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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