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Alzheimer's Disease (AD) and Related DisordersMEMENTONCT01926249

A Cohort of Outpatients From French Research Memory Centers in Order to Improve Knowledge on Alzheimer's Disease and Related Disorders

An observational study of Alzheimer's Disease (AD) and Related Disorders, run by University Hospital, Bordeaux at 29 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,325 participants
Where
29 sitesFrance
Study dates
8 Dec 2011to 29 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Stroke that has occurred in the last three months
  • Schizophrenia history (DSM-IV criteria)
  • Illiteracy, is unable to count or to read

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

France29 sites

  • CHU d'Amiens

    Amiens

  • CHU d'Angers

    Angers

  • CHU de Besançon

    Besançon

  • AP-HP - Avicenne

    Bobigny

  • CHU de Bordeaux - Pellegrin

    Bordeaux, 33000

  • CHU de Bordeaux - Hôpital Xavier-Arnozan

    Bordeaux

  • CHU de Brest

    Brest

  • CHU de Clermont-Ferrand

    Clermont-Ferrand

  • Hôpitaux civils de Colmar

    Colmar

  • CHU de Dijon

    Dijon

  • CHU de Grenoble

    Grenoble

  • CHU de Lille

    Lille

  • Hospices civils de Lyon

    Lyon

  • AP-HM

    Marseille

  • CHU de Montpellier

    Montpellier

  • CHU de Nancy

    Nancy

  • CHU de Nantes

    Nantes

  • CHU de Nice

    Nice

  • AP-HP - Hôpital BROCA

    Paris

  • AP-HP - Hôpital LARIBOISIERE

    Paris

  • Ap-Hp La Pitié-Salpêtrière

    Paris

  • CHU de Poitiers

    Poitiers

  • CHU de Rouen

    Rouen

  • CHU de Saint-Etienne - Hôpital de la charité

    Saint-Etienne

  • CHU de Saint-Etienne - Hôpital Nord

    Saint-Etienne

  • CHU de Strasbourg

    Strasbourg

  • CHU de Toulouse - Hôpital Purpan

    Toulouse

  • CHU de Toulouse

    Toulouse

  • CHU de Tours

    Tours

Other trials in France

About this study

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

Read the 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.

Keywords
Alzheimer's disease, Mild Cognitive Impairment
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01926249
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression to clinical dementia stage according to standardized classifications (DSM-IV for dementia and NINCDS-ADRDA for Alzheimer's disease)

    Measured: Each 6 months from baseline for 5 years (M60)

Secondary outcomes (8)

  1. Mortality

    Measured: Each 6 months from baseline for 5 years (M60)

  2. Loss of autonomy based on functional activity assessment

    Measured: Each 6 months from baseline for 5 years (M60)

  3. Institutionalisation

    Measured: Each 6 months from baseline for 5 years (M60)

  4. Speed of cognitive decline based on change in cognitive performances

    Measured: Each 6 months from baseline for 5 years (M60)

  5. Cardiovascular event (Stroke and Coronary events)

    Measured: Each 6 months from baseline for 5 years (M60)

  6. Quality of life

    Measured: Each 6 months from baseline for 5 years (M60)

  7. Prodromal AD (Pre-symptomatic dementia)

    Measured: 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)

    Measured: Each 6 months from baseline for 5 years (M60)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2013 (estimated)
  2. Study start8 Dec 2011
  3. Primary completion29 Oct 2021
  4. Study completion29 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01926249
Sponsor's protocol ID
CHUBX 2010/47
Acronym
MEMENTO
Status last verified
Jan 2022
First submitted
16 Aug 2013
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No

Publications

  • Blanc F, Bouteloup V, Paquet C, Chupin M, Pasquier F, Gabelle A, Ceccaldi M, de Sousa PL, Krolak-Salmon P, David R, Fischer C, Dartigues JF, Wallon D, Moreaud O, Sauvee M, Belin C, Roubaud C, Botzung A, Ravier A, Demuynck C, Namer I, Habert MO, Bousiges O, Schorr B, Muller C, Philippi N, Chene G, Cretin B, Mangin JF, Dufouil C. Cognitive and neuroimaging outcome of very prodromal dementia with Lewy bodies. Geroscience. 2026 Feb;48(1):1051-1062. doi: 10.1007/s11357-025-01701-x. Epub 2025 May 25.

    PubMed 40415136

  • Lespinasse J, Dufouil C, Proust-Lima C. Disease progression model anchored around clinical diagnosis in longitudinal cohorts: example of Alzheimer's disease and related dementia. BMC Med Res Methodol. 2023 Sep 5;23(1):199. doi: 10.1186/s12874-023-02009-0.

    PubMed 37670234

  • Blanc F, Bouteloup V, Paquet C, Chupin M, Pasquier F, Gabelle A, Ceccaldi M, de Sousa PL, Krolak-Salmon P, David R, Fischer C, Dartigues JF, Wallon D, Moreaud O, Sauvee M, Belin C, Harston S, Botzung A, Albasser T, Demuynck C, Namer I, Habert MO, Kremer S, Bousiges O, Verny M, Muller C, Philippi N, Chene G, Cretin B, Mangin JF, Dufouil C. Prodromal characteristics of dementia with Lewy bodies: baseline results of the MEMENTO memory clinics nationwide cohort. Alzheimers Res Ther. 2022 Jul 19;14(1):96. doi: 10.1186/s13195-022-01037-0.

    PubMed 35854388

  • Dufouil C, Dubois B, Vellas B, Pasquier F, Blanc F, Hugon J, Hanon O, Dartigues JF, Harston S, Gabelle A, Ceccaldi M, Beauchet O, Krolak-Salmon P, David R, Rouaud O, Godefroy O, Belin C, Rouch I, Auguste N, Wallon D, Benetos A, Pariente J, Paccalin M, Moreaud O, Hommet C, Sellal F, Boutoleau-Bretonniere C, Jalenques I, Gentric A, Vandel P, Azouani C, Fillon L, Fischer C, Savarieau H, Operto G, Bertin H, Chupin M, Bouteloup V, Habert MO, Mangin JF, Chene G; MEMENTO cohort Study Group. Cognitive and imaging markers in non-demented subjects attending a memory clinic: study design and baseline findings of the MEMENTO cohort. Alzheimers Res Ther. 2017 Aug 29;9(1):67. doi: 10.1186/s13195-017-0288-0.

    PubMed 28851447

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer's Disease (AD) and Related Disorders, run by University Hospital, Bordeaux at 29 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). 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 NCT01926249, which also lists 4 linked publications.

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 11 Jan 2022.

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