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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
Recruitment Status : Active, not recruiting
First Posted : August 20, 2013
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
Fondation Plan Alzheimer
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
A Multicenter national prospective cohort study including at least 2300 individuals consecutively recruited from French Research Memory Centers and followed-up over 5 years.

Condition or disease
Alzheimer's Disease (AD) and Related Disorders

Detailed Description:

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 2011
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Individuals at high risk of developing Alzheimer's dementia
  • 2000 participants with a newly identified cognitive deficit defined as performing worse than one standard deviation to the mean in one or more cognitive domain (memory, language, praxis, visuospatial abilities, attention and executive functions), not demented.
  • 300 participants with an isolated cognitive complaint and an age of 60 years or more.



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
  2. Loss of autonomy based on functional activity assessment [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
  3. Institutionalisation [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
  4. Speed of cognitive decline based on change in cognitive performances [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
  5. Cardiovascular event (Stroke and Coronary events) [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
  6. Quality of life [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
  7. Prodromal AD (Pre-symptomatic dementia) [ Time Frame: Each 6 months from baseline for 5 years (M60) ]
  8. 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)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients from French Research Memory Centers with at least a light cognitive deficit defined as performing worse than one standard deviation to the mean in one or more cognitive domains or an isolated cognitive complaint regardless of its duration while being 60 years and older.
Criteria

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

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
University Hospital, Bordeaux
Fondation Plan Alzheimer
Investigators
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: April 6, 2017
Last Verified: April 2017

Keywords provided by University Hospital, Bordeaux:
Alzheimer's disease
Mild Cognitive Impairment

Additional relevant MeSH terms:
Disease
Alzheimer Disease
Pathologic Processes
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders