A Cohort of Outpatients From French Research Memory Centers in Order to Improve Knowledge on Alzheimer's Disease and Related Disorders (MEMENTO)
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| ClinicalTrials.gov Identifier: NCT01926249 |
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Recruitment Status :
Active, not recruiting
First Posted : August 20, 2013
Last Update Posted : June 14, 2018
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| Condition or disease |
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| Alzheimer's Disease (AD) and Related Disorders |
The increasing incidence of Alzheimer's disease (AD) and related disorders with the change in the world age demographic is a source of major public health concern. Early and accurate identification of individuals at high risk of Alzheimer's Disease has become a priority. Over the last years, research has focused on the concept of "Mild Cognitive Impairment" which happens to be a heterogeneous condition as, depending on the studies, Mild Cognitive Impairment patients' conversion rates to dementia range from 2 to 15 percent per year. A study of the full range of stages of evolution, from preclinical stage, to clinical expression of dementia or death is therefore of utmost importance to improve our knowledge on AD and trigger the development of new treatments, especially if between stages transition can be related to neuroimaging (either structural or molecular), biological (Cerebro-Spinal Fluid, serum or plasma) or vascular damages markers. However, if all the above markers have been shown to be individually associated with worsening of cognitive status, no prior study has simultaneously explored the association of a large panel of risk factors and biomarkers with the progression through early signs of cognitive impairment until AD in a large sample of study participants. In parallel to improving the knowledge on AD, it is also important to better estimate the social and economic burden of AD and their consequences on the individuals and their circle and how they evolve from early phase (pre-clinical) of the disease to the most severe stages.
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.
One expected impact is to increase knowledge on the progression from early signs of cognitive impairment to AD and estimate associations between these signs and level of biomarkers assessed through imaging or blood or CSF samples. Another major expected impact is to standardise and harmonise protocols in terms of clinical and neuro-psychological examinations, biological markers, neuroimaging markers, diagnosis of dementia, support to caregivers and informants.
| Study Type : | Observational |
| Estimated Enrollment : | 2300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Cohort of Outpatients From French Research Memory Centers in Order to Improve Knowledge on Alzheimer's Disease and Related Disorders |
| Actual Study Start Date : | April 8, 2011 |
| Estimated Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | June 2019 |
| Group/Cohort |
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Individuals at high risk of developing Alzheimer's dementia
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- Progression to clinical dementia stage according to standardized classifications (DSM-IV for dementia and NINCDS-ADRDA for Alzheimer's disease) [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
- Mortality [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
- Loss of autonomy based on functional activity assessment [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
- Institutionalisation [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
- Speed of cognitive decline based on change in cognitive performances [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
- Cardiovascular event (Stroke and Coronary events) [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
- Quality of life [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
- Prodromal AD (Pre-symptomatic dementia) [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
- Longitudinal evolution of biomarkers measured from blood, Cerebro-Spinal Fluid (CSF), structural neuroimaging (MRI) and molecular neuroimaging (18F-FDG PET) [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
Biospecimen Retention: Samples With DNA
- Blood sampling
- Lumbar puncture (samples without DNA)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
- Or having isolated cognitive complaint regardless of its duration while being 60 years and older
- 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
Exclusion Criteria:
- 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 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926249
| France | |
| CHU d'Amiens | |
| Amiens, France | |
| CHU d'Angers | |
| Angers, France | |
| CHU de Besançon | |
| Besancon, France | |
| APHP - Avicenne | |
| Bobigny, France | |
| CHU de Bordeaux - Pellegrin | |
| Bordeaux, France, 33000 | |
| CHU de Bordeaux - Hôpital Xavier-Arnozan | |
| Bordeaux, France | |
| CHU de Brest | |
| Brest, France | |
| CHU de Clermont-Ferrand | |
| Clermont-ferrand, France | |
| Hôpitaux civils de Colmar | |
| Colmar, France | |
| CHU de Dijon | |
| Dijon, France | |
| CHU de Grenoble | |
| Grenoble, France | |
| CHU de Lille | |
| Lille, France | |
| Hospices civils de Lyon | |
| Lyon, France | |
| AP-HM | |
| Marseille, France | |
| CHU de Montpellier | |
| Montpellier, France | |
| CHU de Nancy | |
| Nancy, France | |
| CHU de Nantes | |
| Nantes, France | |
| CHU de Nice | |
| Nice, France | |
| AP-HP - Hôpital BROCA | |
| Paris, France | |
| AP-HP - Hôpital LARIBOISIERE | |
| Paris, France | |
| Ap-Hp La Pitié-Salpêtrière | |
| Paris, France | |
| CHU de Poitiers | |
| Poitiers, France | |
| CHU de Rouen | |
| Rouen, France | |
| CHU de Saint-Etienne | |
| Saint Etienne, France | |
| CHU de Saint-Etienne | |
| Saint-etienne, France | |
| CHU de Strasbourg | |
| Strasbourg, France | |
| CHU de Toulouse - Hôpital Purpan | |
| Toulouse, France | |
| CHU de Toulouse | |
| Toulouse, France | |
| CHU de Tours | |
| Tours, France | |
| Principal Investigator: | Genevieve CHENE, Prof | CIC-EC7 - ISPED - CHU de Bodeaux | |
| Study Chair: | Geneviève CHENE, Prof | CIC-EC7 - ISPED - CHU de Bordeaux | |
| Study Director: | Carole DUFOUIL, Director | CIC-EC7 - ISPED - CHU de Bordeaux |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT01926249 History of Changes |
| Other Study ID Numbers: |
CHUBX 2010/47 |
| First Posted: | August 20, 2013 Key Record Dates |
| Last Update Posted: | June 14, 2018 |
| Last Verified: | June 2018 |
Keywords provided by University Hospital, Bordeaux:
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Alzheimer's disease Mild Cognitive Impairment |
Additional relevant MeSH terms:
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Disease Alzheimer Disease Pathologic Processes Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |