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Trial record 11 of 30 for:    alzheimer dijon

Longitudinal Study of Brain Amyloid imaGing in MEMENTO (MEMENTOAmyGing)

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ClinicalTrials.gov Identifier: NCT02164643
Recruitment Status : Recruiting
First Posted : June 16, 2014
Last Update Posted : December 23, 2016
Sponsor:
Collaborators:
Fondation Plan Alzheimer
GE Healthcare
Avid Radiopharmaceuticals
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease (AD) and Related Disorders Drug: Flutemetamol (18F) Drug: Florbetapir (18F) Phase 3

Detailed Description:

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Longitudinal Study of Brain Amyloid imaGing in MEMENTO
Study Start Date : June 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Florbetapir (18F) Drug: Florbetapir (18F)
Experimental: Flutemetamol (18F) Drug: Flutemetamol (18F)



Primary Outcome Measures :
  1. Progression to clinical dementia stage according to standardized classifications (DSM-IV and NINCDS-ADRDA) as described in the MEMENTO protocol. [ Time Frame: 24 months from baseline ]

Secondary Outcome Measures :
  1. Longitudinal evolution of amyloid load measured through either Florbetapir (18F) or Flutemetamol (18F) [ Time Frame: 24 months from baseline ]
  2. Speed of cognitive decline based on change in cognitive performances [ Time Frame: 24 months from baseline ]
  3. Longitudinal evolution of biomarkers measured from blood, CSF, structural neuroimaging (MRI) and glucose metabolism molecular neuroimaging (18F-FDG PET). [ Time Frame: 24 months from baseline ]
  4. Mortality [ Time Frame: 24 months from baseline ]
  5. Loss of autonomy based on functional activity assessment [ Time Frame: 24 months from baseline ]
  6. Institutionalization [ Time Frame: 24 months from baseline ]
  7. Cardiovascular event (Stroke and Coronary events) [ Time Frame: 24 months from baseline ]
  8. Quality of life [ Time Frame: 24 months from baseline ]
  9. Prodromal AD (Pre-symptomatic dementia) [ Time Frame: 24 months from the baseline ]
  10. Etiology of dementia, when converted [ Time Frame: 24 months from the baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164643


Contacts
Contact: Geneviève CHENE, Prof. (0)5 57 57 13 92 ext +33 genevieve.chene@isped.u-bordeaux2.fr
Contact: Carole DUFOUIL, Director (0)5 57 57 14 23 ext +33 carole.dufouil@isped.u-bordeaux2.fr

Locations
France
CHU d'Angers Recruiting
Angers, France
Contact: Olivier BEAUCHET, Prof         
Principal Investigator: Olivier BEAUCHET, Prof         
CHU de Besançon Not yet recruiting
Besancon, France
Contact: Pierre VANDEL, Prof         
Principal Investigator: Pierre VANDEL, Prof         
APHP - Avicenne Recruiting
Bobigny, France
Contact: Caroline BELIN, MD         
Principal Investigator: Catherine BELIN, MD         
CHU de Bordeaux - Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Jean-François DARTIGUES, Prof         
Principal Investigator: Jean-François DARTIGUES, Prof         
CHU de Bordeaux - Hôpital Xavier-Arnozan Recruiting
Bordeaux, France
Contact: Sandrine HARSTON, MD         
Principal Investigator: Sandrine HARTSON, MD         
CHU de Brest Recruiting
Brest, France
Contact: Armelle GENTRIC, Prof         
Principal Investigator: Armelle GENTRIC, Prof         
CHU de Clermont-Ferrand Recruiting
Clermont-ferrand, France
Contact: Isabelle JALENQUES, Prof         
Principal Investigator: Isabelle JALENQUES, Prof         
CHU de Dijon Recruiting
Dijon, France
Contact: Olivier ROUAUD, MD         
Principal Investigator: Olivier ROUAUD, MD         
CHU de Grenoble Recruiting
Grenoble, France
Contact: Olivier MOREAUD, MD         
Principal Investigator: Olivier MOREAUD, MD         
CHU de Lille Recruiting
Lille, France
Contact: Florence PASQUIER, Prof         
Principal Investigator: Florence PASQUIER, Prof         
Hospices civils de Lyon Recruiting
Lyon, France
Contact: Pierre KROLAK-SALMON, Prof         
Principal Investigator: Pierre KROLAK-SALMON, Prof         
AP-HM Recruiting
Marseille, France
Contact: Mathieu CECCALDI, Prof         
Principal Investigator: Mathieu CECCALDI, Prof         
CHU de Montpellier Recruiting
Montpellier, France
Contact: Audrey GABELLE, MD         
Principal Investigator: Audrey GABELLE, MD         
CHU de Nancy Recruiting
Nancy, France
Contact: Athanase BENETOS, Prof         
Principal Investigator: Athanase BENETOS, Prof         
CHU de Nice Recruiting
Nice, France
Contact: Philippe ROBERT, Prof         
Principal Investigator: Philippe ROBERT, Prof         
AP-HP - Hôpital BROCA Not yet recruiting
Paris, France
Contact: Olivier HANON, Prof         
Principal Investigator: Olivier HANON, Prof         
AP-HP - Hôpital LARIBOISIERE Recruiting
Paris, France
Contact: Jacques HUGON, Prof         
Principal Investigator: Jacques HUGON, Prof         
Ap-Hp La Pitié-Salpêtrière Not yet recruiting
Paris, France
Contact: Bruno DUBOIS, Prof         
Principal Investigator: Bruno DUBOIS, Prof         
CHU de Poitiers Recruiting
Poitiers, France
Contact: Marc PACCALIN, Prof         
Principal Investigator: Marc PACCALIN, Prof         
CHU de Rouen Recruiting
Rouen, France
Contact: Didier HANNEQUIN, Prof         
Principal Investigator: Didier HANNEQUIN, Prof         
CHU de Saint-Etienne Recruiting
Saint-etienne, France
Contact: Marie-Odile BARRELLON, MD         
Principal Investigator: Marie-Odile BARRELLON, MD         
CHU de Saint-Etienne Recruiting
Saint-etienne, France
Contact: Nicolas AUGUSTE, MD         
Principal Investigator: Nicolas AUGUSTE, MD         
CHU de Stasbourg Recruiting
Stasbourg, France
Contact: Frédéric BLANC, MD         
Principal Investigator: Frédéric BLANC, MD         
CHU de Toulouse - Hôpital Purpan Recruiting
Toulouse, France
Contact: Jérémie PARIENTE, Prof         
Principal Investigator: Jérémy PARIENTE, Prof         
CHU de Toulouse Recruiting
Toulouse, France
Contact: Bruno VELLAS, Prof         
Principal Investigator: Bruno VELLAS, Prof         
CHU de Tours Recruiting
Tours, France
Contact: Caroline HOMMET, Prof         
Principal Investigator: Caroline HOMMET, Prof         
Sponsors and Collaborators
University Hospital, Bordeaux
Fondation Plan Alzheimer
GE Healthcare
Avid Radiopharmaceuticals
Investigators
Principal Investigator: Genevieve CHENE, Prof CIC-EC7 - ISPED - CHU de Bodeaux
Study Chair: Geneviève CHENE, Prof CIC-EC7 - ISPED - CHU de Bordeaux
Study Director: 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

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02164643     History of Changes
Other Study ID Numbers: CHUBX 2010/47 A
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016

Keywords provided by University Hospital, Bordeaux:
Alzheimer's disease
Mild Cognitive Impairment

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders