Longitudinal Study of Brain Amyloid imaGing in MEMENTO

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborators: Avid Radiopharmaceuticals; Fondation Plan Alzheimer; GE Healthcare
• Treatments: Flutemetamol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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