Trial | NCT02164643  Report issue

Official Title

Longitudinal Study of Brain Amyloid imaGing in MEMENTO

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    448
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.
Alzheimer's disease (AD) is the most common cause of dementia in the elderly, affecting approximately 7.3 million people in Europe. AD is a clinicopathologic entity for which the definitive diagnosis requires both the presence of the clinical signs of dementia and pathological evidence of amyloid plaque in the brain (obtained at autopsy).

Currently, diagnosis of AD at early stage of the disease is hampered by the lack of noninvasive and validated biomarkers of the underlying pathology. On one hand, it is suggested that between 10% and 20% of patients currently diagnosed with AD, based on clinical evidence solely, lack AD pathology at autopsy, and on the other hand community physicians may not diagnose AD in 33% of patients with mild signs and symptoms. Thus, there is a need for validated diagnostic biomarker that could help clinicians separate patients who do not have AD from those who have pathological signs and should be referred for further evaluation and care management. Furthermore, little is known on the prognosis value for dementia conversion of current biomarkers of AD pathology at a preclinical or presymptomatic stage.

Recently, 18F-labeled positron emission tomography (PET) imaging agents have been developed that bind with high affinity to the amyloid-β (Aβ) peptide fibrils that constitute amyloid plaques, and thus, have potential value as an imaging biomarkers for amyloid deposits in subjects with cognitive impairment or isolated cognitive complaints.

The principal objective of this ancillary study is to investigate the prospective association between PET amyloid load, measured twice two years apart, through either Florbetapir (18F) or Flutemetamol (18F) radioligands, and dementia incidence over up to 5 years of follow-up in a sample of individuals presenting with a spectrum of cognitive profiles ranging from isolated cognitive complaints to cognitive deficits without dementia.

The secondary objectives are the following:

To assess the association between change in amyloid load and clinical evolution of participants (both functional and cognitive)
To estimate the prevalence of new research criteria for preclinical Alzheimer's disease
To investigate long-term outcome of preclinical Alzheimer's disease according to NIA-AA criteria
To assess the determinants of change in amyloid load over two years
To study the interrelationships between biomarkers
To assess the added value of amyloid binding agent (Florbetapir (18F) and Flutemetamol (18F)) in combination with other biomarkers (neuropsychological, genetics, plasma, serum, CSF, structural neuroimaging, 18F-FDG-PET) to predict clinical dementia onset
To assess the diagnostic accuracy of amyloid agent Florbetapir (18F) and Flutemetamol (18F) to differentiate AD from other types of dementia (differential diagnosis)
To study the link between amyloid binding agent and survivalstudy design
Study Started
Jun 10
2014
Primary Completion
Oct 09
2019
Study Completion
Oct 09
2019
Last Update
Feb 03
2022

Drug Flutemetamol (18F)

Drug Florbetapir (18F)

Florbetapir (18F) Experimental

Flutemetamol (18F) Experimental

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
No Results Posted