ITMO public health
Last update : 07/01/2015 | Version : 1 | ID : 7969
| General | |
| Identification | |
| Detailed name | Longitudinal Study on Multimodal Imaging for Early-Stage Alzheimer's Disease: Biomarkers for Detection and Progression and Physiopathological Mechanisms |
| Sign or acronym | IMAP+ |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL:1238252; CPP 2011-A01493-38 |
| General Aspects | |
| Medical area |
Neurology Psychology and psychiatry |
| Health determinants |
Genetic |
| Keywords | Genetics, early diagnosis, normal ageing, neuroimaging, PET, MRI, fMRI, neuroanatomy, molecular imaging, FDG-PET, Alzheimer's disease, biomarkers, AV45 |
| Scientific investigator(s) (Contact) | |
| Name of the director | Chételat |
| Surname | Gaël |
| Address | CHU Côte de Nacre Bd Henri Becquerel, BP 5229, 14033 CAEN |
| Phone | +33 (0)2 31 47 01 73 |
| chetelat@cyceron.fr | |
| Unit | U1077 Neuropsychologie cognitive et neuroanatomie fonctionnelle de la mémoire humaineÉquipe/activité : Imagerie multimodale des maladies neurodégénératives |
| Organization | Institut national de la santé et de la recherche médicale - Inserm ; CHU Caen ; Université de Caen ; |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | French Alzheimer's Association, Alzheimer's Foundation Plan [Fondation Plan Alzheimer] (Alzheimer's Plan 2008-2012), Hospital Clinical Research Programme (ANR LONGVIE 2007), Lower-Normandy Region, French National Institute of Health and Medical Research (INSERM) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Caen |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Healthy subjects will be recruited from advertisements in local newspapers, on websites, during conferences, as well as posting and/or distribution in public places or through word of mouth. Subjects will be invited to attend research centres for the screening visit following recruitment. NORMA subjects will be recruited through correspondence sent to neurologists from the French capital, having been diagnosed with familial AD where results demonstrating causal mutation were established. Individuals that meet the selection criteria will be included in the study. Genetic analyses will be performed in Rouen and all other tests will be conducted in Caen. SCI, MCI, MA and SAND patients will be recruited from neurology departments or memory assessment services across various recruitment centres (CHU in Caen, Rennes, Rouen, Lille and Tours). Individuals should be accompanied by someone they know at baseline and subsequent visits. This person, referred to as the "accompanying party" should be quite close to the patient and know them well, i.e. spends at least one day per week with them (spouse, family member, neighbour or friend), as they will be asked questions to better identify disorders. This person should be the same where possible. Only questions regarding the patient's memory disorders, habits and daily activities will be asked. 280 subjects/patients to be included: - 40 young healthy control subjects (18-39 years old) - 40 middle-aged healthy control subjects (40-59 years old) - 40 elderly healthy control subjects (aged 60+) - 50 NORMA subjects (NORMaux Apparentés) - 40 patients with subjective cognitive impairment - 40 patients with mild cognitive impairment (Mild Cognitive Impairment - MCI) - 30 patients with probable Alzheimer's disease (AD) - 15 patients with amnesic syndrome that is not neurodegenerative (SAND). |
| Database objective | |
| Main objective |
General objective: To study and compare the effectiveness of different in vivo markers to predict cognitive decline in patients at risk of developing Alzheimer's disease through neuroimaging, neuropsychology and biology measures.
Secondary objectives: To study: i) Deterioration in NORMA subjects, as well as SCI, MCI, AD and SAND patients compared with healthy subjects of the same age; ii) Deterioration in E4 allele and apolipoprotein E (ApoE) carriers compared to non-carriers; iii) Cerebral and cognitive changes during normal ageing; iv) Progress and dynamics of different biomarkers during follow-up. To study the links between different deterioration profiles (intra-modality comparison and correlation), as well as differences in inter-group progression profiles. |
| Inclusion criteria |
Education level equal to 7 years or higher, native language is French, signed informed consent, medical, neurological and neuroimaging tests, as well as neuropsychological diagnostic test battery.
Control subjects: normal performance according to age and education level in all diagnostic battery tests. Middle-aged (40-59 years old): no memory complaints. Elderly (aged 60+): living at home, independent, no memory complaints. NORMA (aged 18+) with identified disease, carriers of mutated gene associated with familial early-onset AD, normal performance according to age and education level in all diagnostic battery tests. Patients from memory assessment centres: SCI (aged 50+), no memory complaints, normal performance according to age and education level in all diagnostic battery tests. MCI meeting current amnestic MCI criteria with memory complaints, objective episodic memory deficits, performances in other cognitive functions where memory loss could occur, standard performance for age and education level in assessments of overall cognitive ability, independent in everyday life, no dementia according to DSM-IV criteria and no probable AD according to NINCDS-ADRDA criteria. Alzheimer's patients meeting NINCDS-ADRDA criteria for probable AD with abnormal overall cognitive function and deficits in at least 2 cognitive areas identified by diagnostic battery tests; mild- to moderate-stage AD; accompanying party's signed informed consent. SAND: CHU neurology departments - major episodic memory disorder that may be related to an objective deficit in executive function and standard performance for age and education level in all diagnostic battery tests measuring instrumental function. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | 3/4 of patients are from the region. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2012 |
| Date of last collection (YYYY or MM/YYYY) | 2017 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 280 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical data collected through clinical records only include SCI, MCI, AD and SAND patients. |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview Phone interview |
| Details of collected declarative data | Neuropsychological tests include self-administered questionnaires, face-to-face interview and initial contact by phone. |
| Paraclinical data (detail) | Imaging: Anatomical MRI, fMRI at rest, active fMRI, FDG-PET and PET AV-45 |
| Biological data (detail) | Biological components (blood and CSF): i) blood test for fibrinolysis markers (tPA, ADAMTS-4); ii) AB40 and AB42 blood tests and AB40, AB42 CSF, tau protein and its phosphorylated form, iii) ApoE genotyping; iv) potential mutated gene sequencing in NORMA subjects |
| Administrative data (detail) | Civil status, sex, native language, education level |
| Presence of a biobank |
Yes |
| Contents of biobank |
Plasma DNA |
| Details of biobank content | Components stored at -80°C. |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Subjects/patients attend 6 examinations lasting approx. 2 hours + one blood sample. All examinations are conducted over a period of approx. 1 month. Subjects/patients are treated by a contact person that monitors and supports them throughout the protocol. Collected data are reviewed in a multimodal meeting. Imaging data quality control results are also reported during this meeting. Collected data are reviewed during a diagnostic commission so that subject/patient results, as well as their enrolment category, can be reported on a case-by-case basis. |
| Classifications used | NINCDS-ADRDA and DSM IV |
| Quality procedure(s) used | A diagnostic commission is organised on a monthly basis to report subject/patient neuropsychological results, as well as their enrolment category, on a case-by-case basis. A multimodal meeting is organised on a monthly basis to report quality control results for imaging data. This trial is monitored by a person appointed by the CHU to ensure that exact, complete and reliable data is collected and to provide logistical support to research centres. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Elderly healthy subjects, NORMA subjects, as well as SCI and MCI patients are monitored over a period of 36 months Young, middle-aged and AD patients are monitored over a period of 18 months Post-monitoring enrolment after 18 months; all participants will be asked to take all of the baseline tests again in an almost identical fashion: detailed neuropsychological evaluation, blood sample (without genotyping), 2 MRI sessions, FDG-PET at rest and PET-AV45 test. Post-monitoring enrolment after 36 months, elderly healthy subjects, NORMA subjects, as well as SCI and MCI patients will be asked to take the same tests as described for the visit at 18 months. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/docs/00/93/16/85/PDF/MainManuscrit_GC_RLJ_withTables-and-figures.pdf |
| Link to the document | http://www.em-consulte.com/article/840363/alertePM |
| Link to the document | http://www.hal.inserm.fr/inserm-00844867 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23084083 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23152610 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/24179859 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23670109 |
| Link to the document | http://www.nature.com/nrneurol/journal/v9/n6/pdf/nrneurol.2013.21-c2.pdf?WT.ec_id |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23631988 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23518010 |
| Link to the document | http://www.hal.inserm.fr/inserm-00806868 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22796505 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22119654 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22252372 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Publications.
Database access conditions are currently being determined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
| ABOUT | CATALOG | RESOURCES | USEFUL LINKS |
This site complies with the HONcode standard for trustworthy health information: |
8 rue de la Croix Jarry 75013 Paris Phone : +33 1 44 23 67 47 |
Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05
