Longitudinal Study of Brain Amyloid imaGing in MEMENTO

NCT02164643 | Completed Phase 3

• 1 other identifier: CHUBX 2010/47 A
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 26

Brief Summary

A Multicenter national longitudinal cohort study including at least 800 individuals consecutively recruited from French Research Memory Centers and followed-up over 24 month and included in Memento.

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 and NINCDS-ADRDA) as described in the MEMENTO protocol.

  24 months from baseline

Secondary Outcomes (10)

• Longitudinal evolution of amyloid load measured through either Florbetapir (18F) or Flutemetamol (18F)

  24 months from baseline

• Speed of cognitive decline based on change in cognitive performances

  24 months from baseline

• Longitudinal evolution of biomarkers measured from blood, CSF, structural neuroimaging (MRI) and glucose metabolism molecular neuroimaging (18F-FDG PET).

  24 months from baseline

• Mortality

  24 months from baseline

• Loss of autonomy based on functional activity assessment

  24 months from baseline

Study Arms (2)

Florbetapir (18F)

EXPERIMENTAL

Drug: Florbetapir (18F)

Flutemetamol (18F)

EXPERIMENTAL

Drug: Flutemetamol (18F)

Interventions

Flutemetamol (18F) DRUG

Flutemetamol (18F)

Florbetapir (18F) DRUG

Florbetapir (18F)

Eligibility Criteria

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

You may qualify if:

• To be included in MEMENTO
• To have signed a specific MEMENTO-AmyGing informed consent form, prior to any amyloid PET procedures
• To have had or agreed to have 18F-FDG PET scan in MEMENTO
• To tolerate the (18F) PET scan procedures, in the opinion of the clinical site investigator
• Clinical Dementia Rating scale \<0.5 and not demented

You may not qualify if:

• To have a current clinically significant psychiatric condition that neurologists/geriatricians feel would preclude the ability to have a research PET scan
• To be pregnant or breastfeading women
• To have Hypersensitivity to the tracer or to the excipient listed in the summary of the product carateristics (florbetapir Amyvid®) or the Investigator's Brochure (flutemetamol)
• To have a relevant history of severe drug allergy or hypersensitivity (relevant severe drug allergies should be determined by the clinical site investigator or co-clinical site investigator). If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study with a novel compound
• To have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, γ-secretase or γ-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial
• To receive any investigational medications, or have participated in a trial with investigational medications within the last 30 days
• To have participated less than 1 year ago in a biomedical research with injection of one of the amyloid radioligand or to be enrolled in an ongoing biomedical research including amyloid PET scan
• To have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Fondation Plan Alzheimer: collaborator
• GE Healthcare: collaborator
• Avid Radiopharmaceuticals: collaborator

Study Sites (26)

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

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 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 (1)

• Ackley S, Calmasini C, Bouteloup V, Hill-Jarrett TG, Swinnerton KN, Chene G, Dufouil C, Glymour MM; MEMENTO Cohort Study Group and DPUK. Contribution of Global Amyloid-PET Imaging for Predicting Future Cognition in the MEMENTO Cohort. Neurology. 2024 Mar 26;102(6):e208054. doi: 10.1212/WNL.0000000000208054. Epub 2024 Feb 27.

  PMID: 38412412 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

flutemetamol; florbetapir

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

• Florence PASQUIER, Prof

  Head of Lille Memory Clinic, CHRU Lille

  STUDY DIRECTOR

• Marie-Odile HABERT, Prof

  Head of Molecular Imaging Work package for the Center for Image Acquisition and Processing - CHU Pitié-Salpêtrière, AP-HP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 16, 2014
• Study Start: June 10, 2014
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: February 3, 2022

Record last verified: 2022-02

Locations

FR (26)