Memory DisordersMEM-AURANCT03894254
Predictive Factors of Autonomy Loss in Real-life Cohort
A study of Memory Disorders, run by Hospices Civils de Lyon at 5 sites in France.
Trial summary
The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Memory Disorders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,400 participants
- Where
- 5 sitesFrance
- Study dates
- 9 Sep 2020to 1 Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older, undergoing a medical visit in a memory center or neuro-cognition service
- Patients living at home or in housing
- Patients with memory impairment, at all stage of the disease
Who cannot join
- Patients in institution
- Patients under legal protection
- Patients with a hearing or visual impairment, which prevents carrying out examinations
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Hôpital Dugoujon
Caluire-et-Cuire, 69300
Sylvain Gaujard, MD, 04 72 00 15 32 ext. +33, sylvain.gaujard@chu-lyon.fr
- Recruiting
Centre Hospitalier Lyon Sud
Lyon, 69310
Marc Bonnefoy, PhD, 04 78 86 15 81, marc.bonnefoy@chu-lyon.fr
- Recruiting
Service de neuro-cognition et neuro-ophtalmologie du Groupement Hospitalier Est
Lyon
Virginie Desestret, PhD, virginie.desestret@chu-lyon.fr
- Recruiting
CHU Saint-Etienne
Saint-Etienne, 42055
Jean-Claude Getenet, MD, 04 77 12 78 05, j.claude.getenet@chu-st-etienne.fr
- Recruiting
Centre Mémoire de Ressources et de Recherche de Lyon
Villeurbanne, 69100
Pierre Krolak-Salmon, PhD, 04 72 43 20 50, pierre.krolak-salmon@chu-lyon.fr
About this study
Official title: Predictive Factors Associated With Impairment in Functional Autonomy in a Regional Real-life Cohort of Patients With Alzheimer's Disease or Related Disorders (ADRD)
The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The Investigators aim at developing a regional database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative staff and with the University hospital computer science departments.
The main objective is to study the predictive factors associated with change in functional autonomy level, measured every 6 to 12 months in centres across Region Auvergne Rhone-Alpes in France.
The real-life study population will consist in about 5400 patients with ADRD. The inclusion period will be of 3 years, the length of follow-up of each patient will be of 10 years max for a total study length of 13 years.
- Conditions
- Memory Disorders
- Being tested
- no intervention
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This is study carried out in current practice. Patients are undergoing a medical examination in a memory center, with extensive and systematic evaluations for the study involving the following tests: IADL, DAD6, New AGGIR, NPI, and mini-Zarit) assessing the functions (autonomy, behavior and caregiver burden).
| Study group | Role | What they receive |
|---|---|---|
| Patients with subjective cognitive complaint or neurocognitive | Experimental | : Real-life cohort patients with subjective cognitive complaint or neurocognitive disorders undergoing medical examination in memory centers, and for whom extensive evaluations will be performed for the study Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional autonomy level
The Lawton Instrumental Activities of Daily Living (IADL)
Measured: from 6 months to 12 months interval
Functional autonomy level
The Disability Assessment of Dementia (DAD-6)
Measured: from 6 months to 12 months interval
Functional autonomy level
The New-AGGIR (French national score for dependency assessment)
Measured: from 6 months to 12 months interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start9 Sep 2020
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DisordersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Krolak-Salmon, PhD, Principal investigator, Centre Mémoire de Ressources et de Recherche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894254
- Sponsor's protocol ID
- 69HCL18_0613
- Acronym
- MEM-AURA
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2019
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors Associated With Impairment in Functional Autonomy in a Regional Real-life Cohort of Patients With Alzheimer's Disease or Related Disorders (ADRD)
- ClinicalTrials.gov ID
- NCT03894254
- Acronym / sponsor ID
- MEM-AURA / 69HCL18_0613
- Conditions
- Memory Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The Investigators aim at developing a regional database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative staff and with the University hospital computer science departments.
The main objective is to study the predictive factors associated with change in functional autonomy level, measured every 6 to 12 months in centres across Region Auvergne Rhone-Alpes in France.
The real-life study population will consist in about 5400 patients with ADRD. The inclusion period will be of 3 years, the length of follow-up of each patient will be of 10 years max for a total study length of 13 years.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with subjective cognitive complaint or neurocognitive | Experimental | Other: no intervention: Real-life cohort patients with subjective cognitive complaint or neurocognitive disorders undergoing medical examination in memory centers, and for whom extensive evaluations will be performed for the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years and older, undergoing a medical visit in a memory center or neuro-cognition service
- Patients living at home or in housing
- Patients with memory impairment, at all stage of the disease
Key exclusion criteria (3 listed)
- Patients in institution
- Patients under legal protection
- Patients with a hearing or visual impairment, which prevents carrying out examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThis is study carried out in current practice. Patients are undergoing a medical examination in a memory center, with extensive and systematic evaluations for the study involving the following tests: IADL, DAD6, New AGGIR, NPI, and mini-Zarit) assessing the functions (autonomy, behavior and caregiver burden). | Other | Patients with subjective cognitive complaint or neurocognitive |
Primary outcome
Functional autonomy level
Time frame: from 6 months to 12 months interval
The Lawton Instrumental Activities of Daily Living (IADL)
Functional autonomy level
Time frame: from 6 months to 12 months interval
The Disability Assessment of Dementia (DAD-6)
Functional autonomy level
Time frame: from 6 months to 12 months interval
The New-AGGIR (French national score for dependency assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Krolak-Salmon, PhD principal investigator
Centre Mémoire de Ressources et de Recherche
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Memory Disorders, run by Hospices Civils de Lyon at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Krolak-Salmon, PhD (04 72 43 20 50, pierre.krolak-salmon@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional autonomy level (time frame: from 6 months to 12 months interval). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.