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

NCT01926249 | Completed

• 1 other identifier: CHUBX 2010/47
• Study Type: observational
• Target: 2,325
• Locations: 1 country
• Sites: 29

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.

Conditions

Alzheimer's Disease (AD) and Related Disorders

Keywords

Alzheimer's disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

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

  Each 6 months from baseline for 5 years (M60)

Secondary Outcomes (8)

• Mortality

  Each 6 months from baseline for 5 years (M60)

• Loss of autonomy based on functional activity assessment

  Each 6 months from baseline for 5 years (M60)

• Institutionalisation

  Each 6 months from baseline for 5 years (M60)

• Speed of cognitive decline based on change in cognitive performances

  Each 6 months from baseline for 5 years (M60)

• Cardiovascular event (Stroke and Coronary events)

  Each 6 months from baseline for 5 years (M60)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 18 years and above
• 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

You may not qualify if:

• Being under guardianship
• Residence in skilled nursing facility
• Pregnant or breast feeding women
• Alzheimer's disease caused by gene mutations
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Fondation Plan Alzheimer: collaborator

Study Sites (29)

CHU d'Amiens

Amiens, France

Location

CHU d'Angers

Angers, France

Location

CHU de Besançon

Besançon, France

Location

AP-HP - Avicenne

Bobigny, France

Location

CHU de Bordeaux - Pellegrin

Bordeaux, 33000, France

Location

CHU de Bordeaux - Hôpital Xavier-Arnozan

Bordeaux, France

Location

CHU de Brest

Brest, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

Hôpitaux civils de Colmar

Colmar, France

Location

CHU de Dijon

Dijon, France

Location

CHU de Grenoble

Grenoble, France

Location

CHU de Lille

Lille, France

Location

Hospices civils de Lyon

Lyon, France

Location

AP-HM

Marseille, France

Location

CHU de Montpellier

Montpellier, France

Location

CHU de Nancy

Nancy, France

Location

CHU de Nantes

Nantes, France

Location

CHU de Nice

Nice, France

Location

AP-HP - Hôpital BROCA

Paris, France

Location

AP-HP - Hôpital LARIBOISIERE

Paris, France

Location

Ap-Hp La Pitié-Salpêtrière

Paris, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de Rouen

Rouen, France

Location

CHU de Saint-Etienne - Hôpital de la charité

Saint-Etienne, France

Location

CHU de Saint-Etienne - Hôpital Nord

Saint-Etienne, France

Location

CHU de Strasbourg

Strasbourg, France

Location

CHU de Toulouse - Hôpital Purpan

Toulouse, France

Location

CHU de Toulouse

Toulouse, France

Location

CHU de Tours

Tours, France

Location

Related Publications (3)

• 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.

  PMID: 37670234 DERIVED

• 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.

  PMID: 35854388 DERIVED

• 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.

  PMID: 28851447 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Blood sampling * Lumbar puncture (samples without DNA)

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Genevieve CHENE, Prof

  CIC-EC7 - ISPED - CHU de Bodeaux

  PRINCIPAL INVESTIGATOR

• Geneviève CHENE, Prof

  CIC-EC7 - ISPED - CHU de Bordeaux

  STUDY CHAIR

• Carole DUFOUIL, Director

  CIC-EC7 - ISPED - CHU de Bordeaux

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 20, 2013
• Study Start: December 8, 2011
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

FR (29)