Memory ImpairmentMEMORANCT02302482
Predictive Factors and Autonomy Level Change
A study testing The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6 in people with Memory Impairment, run by Hospices Civils de Lyon at 2 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 65 years and older
- Conditions the study is for
- Memory Impairment
- What is being tested?
- The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,860 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2014to Nov 2027
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who undergo a medical visit in the Memory Clinic for the 1st time
- 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 dot not allow to carry out the examination
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Hôpital Dugoujon
Caluire-et-Cuire, 69300
Sylvain Gaujard
Sylvain Gaujard
- Recruiting
Hospices Civils de Lyon - Hôpital des Charpennes
Lyon
Pierre KROLAK-SALMON, Pr, (0)4 72 43 20 50 ext. +33, pierre.krolak-salmon@chu-lyon.fr
Virginie DAUPHINOT, (0)4 72 43 20 50 ext. +33, virginie.dauphinot@chu-lyon.fr
About this study
Official title: Predictive Factors of the Autonomy Level Change Related to Memory Disorders
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 aimed at developing a database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative personal and with the University hospital computer science department. The main objective is to study the predictive factors associated with the change of functional autonomy level, measured every 6 months to 12 months by phone, in a Memory Clinic. The study population would consist in about 1000 patients with ADRD. The length of follow-up of each patient will be 3 years.
- Conditions
- Memory Impairment
- Being tested
- The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6
- Keywords
- Alzheimer's disease or related disorders, Functional autonomy level, Cognitive function, Predictive factors
- Medical subject headings
- Memory Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6Other
| Study group | Role | What they receive |
|---|---|---|
| Functional autonomy level collection | Experimental | Collection of the Functional autonomy level every 6 - 12 months by phone Receives: Other: The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional autonomy level
The scores of "Lawton Instrumental Activities of Daily Living" (IADL) and of "Disability Assessment of Dementia" (DAD-6)
Measured: 3 years
Secondary outcomes (1)
Cognitive function level
Mini Mental Test examination (MMSE)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory ImpairmentStudies 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
- 10,860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302482
- Sponsor's protocol ID
- 2014.868
- Acronym
- MEMORA
- Status last verified
- Jun 2021
- First submitted
- 14 Nov 2014
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Dauphinot V, Moutet C, Rouch I, Verdurand M, Mouchoux C, Delphin-Combe F, Gaujard S, Krolak-Salmon P; MEMORA group. A multicenter cohort study to investigate the factors associated with functional autonomy change in patients with cognitive complaint or neurocognitive disorders: the MEMORA study protocol. BMC Geriatr. 2019 Jul 18;19(1):191. doi: 10.1186/s12877-019-1204-1.
PubMed 31319809
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of the Autonomy Level Change Related to Memory Disorders
- ClinicalTrials.gov ID
- NCT02302482
- Acronym / sponsor ID
- MEMORA / 2014.868
- Conditions
- Memory Impairment
- Keywords
- Alzheimer's disease or related disorders, Functional autonomy level, Cognitive function, Predictive factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,860 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 27 Nov 2014 (estimated)
- 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 aimed at developing a database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative personal and with the University hospital computer science department. The main objective is to study the predictive factors associated with the change of functional autonomy level, measured every 6 months to 12 months by phone, in a Memory Clinic. The study population would consist in about 1000 patients with ADRD. The length of follow-up of each patient will be 3 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 |
|---|---|---|
| Functional autonomy level collection | Experimental | Other: The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6Collection of the Functional autonomy level every 6 - 12 months by phone |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients who undergo a medical visit in the Memory Clinic for the 1st time
- 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 dot not allow to carry out the examination
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 |
|---|---|---|
| The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6 | Other | Functional autonomy level collection |
Primary outcome
Functional autonomy level
Time frame: 3 years
The scores of "Lawton Instrumental Activities of Daily Living" (IADL) and of "Disability Assessment of Dementia" (DAD-6)
1 secondary outcome
Cognitive function level
Time frame: 3 years
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 28 Jun 2021.
- Derived from this study: PubMed 31319809Dauphinot V, Moutet C, Rouch I, Verdurand M, Mouchoux C, Delphin-Combe F, Gaujard S, Krolak-Salmon P; MEMORA group. A multicenter cohort study to investigate the factors associated with functional autonomy change in patients with cognitive complaint or neurocognitive disorders: the MEMORA study protocol. BMC Geriatr. 2019 Jul 18;19(1):191. doi: 10.1186/s12877-019-1204-1.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6 in people with Memory Impairment, run by Hospices Civils de Lyon at 2 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 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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, Professor ((0)4 72 43 20 50 ext. +33, 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: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302482, which also lists 1 linked publication.
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 28 Jun 2021.