Alzheimer's Disease (AD) and Related DisordersPhase 3MEMENTOAmyGingNCT02164643
Longitudinal Study of Brain Amyloid imaGing in MEMENTO
A Phase 3 study testing Flutemetamol (18F) and Florbetapir (18F) in people with Alzheimer's Disease (AD) and Related Disorders, run by University Hospital, Bordeaux at 26 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer's Disease (AD) and Related Disorders
- What is being tested?
- Flutemetamol (18F) and Florbetapir (18F)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 26 sitesFrance
- Study dates
- 10 Jun 2014to 9 Oct 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
CHU d'Angers
Angers
CHU de Besançon
Besançon
AP-HP - Avicenne
Bobigny
CHU de Bordeaux - Pellegrin
Bordeaux, 33000
CHU de Bordeaux - Hôpital Xavier-Arnozan
Bordeaux
CHU de Brest
Brest
CHU de Clermont-Ferrand
Clermont-Ferrand
CHU de Dijon
Dijon
CHU de Grenoble
Grenoble
CHU de Lille
Lille
Hospices civils de Lyon
Lyon
AP-HM
Marseille
CHU de Montpellier
Montpellier
CHU de Nancy
Nancy
CHU de Nice
Nice
AP-HP - Hôpital BROCA
Paris
AP-HP - Hôpital LARIBOISIERE
Paris
Ap-Hp La Pitié-Salpêtrière
Paris
CHU de Poitiers
Poitiers
CHU de Rouen
Rouen
CHU de Saint-Etienne - Hôpital de la charité
Saint-Etienne
CHU de Saint-Etienne - Hôpital Nord
Saint-Etienne
CHU de Strasbourg
Strasbourg
CHU de Toulouse - Hôpital Purpan
Toulouse
CHU de Toulouse
Toulouse
CHU de Tours
Tours
About this study
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.
Read the 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
- Being tested
- Flutemetamol (18F), Florbetapir (18F)
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flutemetamol (18F)Drug
Florbetapir (18F)Drug
| Study group | Role | What they receive |
|---|---|---|
| Florbetapir (18F) | Experimental | Not described Receives: Drug: Florbetapir (18F) |
| Flutemetamol (18F) | Experimental | Not described Receives: Drug: Flutemetamol (18F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to clinical dementia stage according to standardized classifications (DSM-IV and NINCDS-ADRDA) as described in the MEMENTO protocol.
Measured: 24 months from baseline
Secondary outcomes (10)
Longitudinal evolution of amyloid load measured through either Florbetapir (18F) or Flutemetamol (18F)
Measured: 24 months from baseline
Speed of cognitive decline based on change in cognitive performances
Measured: 24 months from baseline
Longitudinal evolution of biomarkers measured from blood, CSF, structural neuroimaging (MRI) and glucose metabolism molecular neuroimaging (18F-FDG PET).
Measured: 24 months from baseline
Mortality
Measured: 24 months from baseline
Loss of autonomy based on functional activity assessment
Measured: 24 months from baseline
Institutionalization
Measured: 24 months from baseline
Cardiovascular event (Stroke and Coronary events)
Measured: 24 months from baseline
Quality of life
Measured: 24 months from baseline
Prodromal AD (Pre-symptomatic dementia)
Measured: 24 months from the baseline
Etiology of dementia, when converted
Measured: 24 months from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study start10 Jun 2014
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Disease (AD) and Related DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Plan Alzheimer, GE Healthcare, Avid Radiopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Genevieve CHENE, Prof, Principal investigator, CIC-EC7 - ISPED - CHU de BodeauxGeneviève CHENE, Prof, Study chair, CIC-EC7 - ISPED - CHU de BordeauxCarole DUFOUIL, Director, Study director, CIC-EC7 - ISPED - CHU de BordeauxFlorence PASQUIER, Prof, Study director, Head of Lille Memory Clinic, CHRU LilleMarie-Odile HABERT, Prof, Study director, Head of Molecular Imaging Work package for the Center for Image Acquisition and Processing - CHU Pitié-Salpêtrière, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164643
- Sponsor's protocol ID
- CHUBX 2010/47 A
- Acronym
- MEMENTOAmyGing
- Status last verified
- Feb 2022
- First submitted
- 12 Jun 2014
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38412412
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Brain Amyloid imaGing in MEMENTO
- ClinicalTrials.gov ID
- NCT02164643
- Acronym / sponsor ID
- MEMENTOAmyGing / CHUBX 2010/47 A
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Fondation Plan Alzheimer, GE Healthcare, Avid Radiopharmaceuticals
- Study start
- 10 Jun 2014 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Florbetapir (18F) | Experimental | Drug: Florbetapir (18F) |
| Flutemetamol (18F) | Experimental | Drug: Flutemetamol (18F) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flutemetamol (18F) | Drug | Flutemetamol (18F) |
| Florbetapir (18F) | Drug | Florbetapir (18F) |
Primary outcome
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
10 secondary outcomes
Longitudinal evolution of amyloid load measured through either Florbetapir (18F) or Flutemetamol (18F)
Time frame: 24 months from baseline
Speed of cognitive decline based on change in cognitive performances
Time frame: 24 months from baseline
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
Mortality
Time frame: 24 months from baseline
Loss of autonomy based on functional activity assessment
Time frame: 24 months from baseline
Institutionalization
Time frame: 24 months from baseline
Cardiovascular event (Stroke and Coronary events)
Time frame: 24 months from baseline
Quality of life
Time frame: 24 months from baseline
Prodromal AD (Pre-symptomatic dementia)
Time frame: 24 months from the baseline
Etiology of dementia, when converted
Time frame: 24 months from the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Derived from this study: PubMed 38412412Ackley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genevieve CHENE, Prof principal investigator
CIC-EC7 - ISPED - CHU de Bodeaux
Geneviève CHENE, Prof study chair
CIC-EC7 - ISPED - CHU de Bordeaux
Carole DUFOUIL, Director study director
CIC-EC7 - ISPED - CHU de Bordeaux
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flutemetamol (18F) and Florbetapir (18F) in people with Alzheimer's Disease (AD) and Related Disorders, run by University Hospital, Bordeaux at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02164643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.