||MEMENTO: a cohort of outpatients from French research memory centers in order to improve knowledge on Alzheimer’s disease and related disorders
||DESIGN OF THE STUDY
A Multicenter national prospective cohort study including at least 2300 individuals consecutively recruited from French memory clinics (CMRRs) and followed-up over 5 years. A pilot phase has been run in 5 memory clinics that have volunteered for that phase and were eligible for the cohort (Bordeaux, Lille, Marseille, Paris Pitié-Salpêtrière, Toulouse). Eligible memory clinics are those that may include at least 50 individuals during the inclusion period, have access to MRI (1.5 or 3T) and biobank facilities.
To study the evolution of a variety of potentially early preclinical signs of AD and related disorders and to estimate the prognostic value of several markers (neuropsychological, vascular damage indicators, psycho-behavioral, socio-economic, genetic, blood, neuroimaging) on progression from early signs to clinical dementia or severe cognitive deterioration stages, and then to death.
* To assess the validity of an operational set of criteria to help identifing the transition from pre-clinical dementia stages,
* To study how vascular risk factors or damage markers are associated with the risk of progression to clinical dementia stage,
* To study prevalence and incidence of prodromal AD or symptomatic pre-dementia according to different definitions,
* To assess factors explaining the variability in time of clinical diagnosis of ADRD,
* To study the relationships between neuropsychiatric symptoms and Alzheimer’s disease or associated dementia progression,
* To assess factors predicting: Mortality, Loss of autonomy, Institutionalisation, Rate of cognitive decline in different areas of cognition, Cardiovascular events during follow-up, Change in quality of life, Risk of developing prodromal AD (pre-symptomatic dementia)
* To study factors associated with change in biomarkers
* To study the frequency of Lewy Body Disease (LBD) symptoms at an early stage and to compare MCI-AD and MCI-LBD participants in term of clinical symptoms, cognition, cerebral imaging characteristics and outcomes
* In the subsample of participants who will reach the clinical stage of dementia, specific objectives will consist in:
-assessing the evolution of the social, behavioural and quality of life characteristics of the participants and their caregivers over time and their relation with clinical progression of the disease;
-describing the efficiency of resources that are used over time
GUIDING PRINCIPLES OF THE COHORT
This cohort, solution to the item 29 of the Plan Alzheimer 2008-2012, has been developed according to the initial memorandum of understanding prepared by the "Comité Plan Cohortes" of the Fondation Plan Alzheimer, and taking on board comments provided by the Scientific Advisory Board (July 2010) of the Fondation Plan Alzheimer and the whole working groups constituted for the preparation of the pilot phase: clinicians, neuro-imaging specialists, biologists, social sciences researchers (from June 2010). The cohort is built to fulfil the guiding principles as follows:
* It should be scientifically original and identify hypothesis-driven research, allowing a corpus of new or confirmatory knowledge of a high-level of evidence to be acquired. In addition, the infrastructure (standardised collection of socio-demographic, clinical, imaging, biological data) may allow to respond, in a timely manner, to additional questions that may emerge over time;
* An interdisciplinary approach is set up as the condition of individuals affected by neurodegenerative dementias involves clinical and biological aspects but also environmental, social and economic components;
* While pursuing its own original scientific objectives, the cohort should have the potential for a comparison with other equivalent cohorts around the world.
This cohort will be including individuals at high risk of developing a neurodegenerative dementia. As such, the cohort is aiming at providing results with an expected impact for those individuals of the same profile, as well as their caregivers and their case management
|#Subjects at Baseline
||Bordeaux University Hospital
||Center for Clinicial Investigation (CIC 1401), Clinical Epidemiology
|Principal Investigator (PI)
|Key Study References
Cognitive and imaging markers in non-demented subjects attending a memory clinic: study design and baseline findings of the MEMENTO cohort. Dufouil et al. Alzheimers Res Ther 2017
|Population Based Study?
|Family Based Study?
|Clinical based sample?
|Is there follow-up data available?
|Were participants included prior to development of dementia (may refer to controls only)?
|Were participants included prior to development of MCI (may refer to controls only)?
|How is data collected?
||Through a dedicated electronic CRF website
|Who carries out data collection?
||Clinical sites CRA
|Does this take place in participants' homes or at a central location?
||Central location (at clinical site)
|Do participants take part individually or are families/partners involved?
An informant might be involved to complete questionnaires, and a dedicated Informant questionnaire is available (optional)
|Dementia cases ascertained as part of study:
|Diagnosis based on review of existing clinical data
|Was diagnosis/primary outcomes made blind to exposure variables?
|How many times followed up?
||11 (Inclusion and 5 annual visits on site, 5 intermediate visits on site or by phone)
|Study start date
|Is study ongoing?
|Is study still recruiting?
||*Aged 18 years and above
*Having at least a light cognitive deficit defined as performing worse than one standard deviation to the mean (compared to age and educational norms) in one or more cognitive domains (assessed from a neuropsychological tests battery exploring memory, language, praxis, vision, executive functions); this deviation being identified for the first time by tests performed less than 6 months preceding date of inclusion (i.e. signature of informed consent)
*Having isolated cognitive complaint regardless of its duration while being 60 years and older (i.e. without cognitive deficit as defined above)(maximum stratum size of 300 participants) ;
*Clinical Dementia Rating scale <=0.5 and not demented
*Visual and auditory acuity adequate for neuropsychological testing
*Having signed an informed consent
*Being affiliated to health insurance
||* Being under guardianship
* Residence in skilled nursing facility
* Pregnant or breast feeding women
* Alzheimer's disease caused by gene mutations
* Meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body) or refusing MRI
* Having a history of intracranial surgery
* Having a neurological disease such as: treated epilepsy, treated Parkinson's disease, Huntington disease, brain tumour, subdural haematoma, progressive supranuclear palsy, history of head trauma followed by persistent neurological deficits
* Stroke that has occurred in the last three months
* Schizophrenia history (DSM-IV criteria)
* Illiteracy, is unable to count or to read