Amyloid Cerebral AngiopathyFBB ACCNCT02664571
Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis
A study testing Pet scan with FBB, MRI scan and APO E genotyping in people with Amyloid Cerebral Angiopathy and Alzheimer Disease, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The main objective of this study is to compare the distribution of Florbetaben (NEURACEQ: FBB) in the brain in amyloid cerebral angiopathy (ACA) manifested by isolated hemosiderosis in non-demented patients with that observed in healthy subjects, patients with ACA and with lobar hematoma(s) and patients with… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyloid Cerebral Angiopathy, Alzheimer Disease
- What is being tested?
- Pet scan with FBB, MRI scan and APO E genotyping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2020to Jul 2021
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must have given his/her informed and signed consent
- The subject must be insured or beneficiary of a health insurance plan
- Healthy volunteers without cerebral neurological history and with normal MRI
- The subject is does not have dementia (Mini Mental State score> 27)
- Exclusion Criteria for patients with amyloid cerebral angiopathy with isolated hemosiderosis:
- The patient is participating in another interventional study
Show all 29Show fewer
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The subject (next of kin or legal representative) refuses to sign the consent
- It is not possible to give the subject or his/her representative informed information
- The patient has an contra-indication for performing an MRI
- The patient is in the acute phase (the tracer does not bind in cases of large hematoma)
- Exclusion Criteria for patients with amyloid cerebral angiopathy with with lobar hematoma(s):
- The patient is participating in another interventional study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The subject (next of kin or legal representative) refuses to sign the consent
- It is not possible to give the subject or his/her representative informed information
- The patient has an contra-indication for performing an MRI
- The patient is in the acute phase (the tracer does not bind in cases of large hematoma)
- Exclusion Criteria fpr patients with Alzheimer's type dementia without MRI signs in favor of amyloid cerebral angiopathy:
- The patient is participating in another interventional study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The subject (next of kin or legal representative) refuses to sign the consent
- It is not possible to give the subject or his/her representative informed information
- The patient has an contra-indication for performing an MRI
- The patient is in the acute phase (the tracer does not bind in cases of large hematoma)
- Haemosiderosis or history of lobar hematoma or other visible cerebral history on MRI
Who cannot join
- The subject is participating in another interventional study
- The subject is in an exclusion period determined by a previous study
- The subject is under judicial protection
- The subject (next of kin or legal representative) refuses to sign the consent
- It is not possible to give the subject or his/her representative informed information
- The subject has an contra-indication for performing an MRI
- Abnormal MRI
- The groups will be matched according to sex and age (by increments of 5 years) to the extent possible. Because amyloid cerebral angiopathy is a very rare condition, matching the two factors may be difficult to achieve. We therefore anticipate where appropriate to focus matching on age.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
CH de Perpignan - Hôpital Saint Jean
Perpignan, 66046
About this study
Official title: Evaluation of Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis
The main objective of this study is to compare the distribution of Florbetaben (NEURACEQ: FBB) in the brain in amyloid cerebral angiopathy (ACA) manifested by isolated hemosiderosis in non-demented patients with that observed in healthy subjects, patients with ACA and with lobar hematoma(s) and patients with Alzheimer's dementia without MRI signs in favor of ACA.
Read the detailed description
The secondary objectives of this study are to compare among groups:
- The associated micro-bleeds. B. Associated leukoencephalopathy. C. Contrast observed in lobar Virchow-Robin perivascular spaces. D. Apolipoprotein E genotypes.
- Conditions
- Amyloid Cerebral Angiopathy, Alzheimer Disease
- Being tested
- Pet scan with FBB, MRI scan, APO E genotyping
- Medical subject headings
- Cerebral Amyloid Angiopathy, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pet scan with FBBDevice
Patients will have a pet scan with Florbetaben (NEURACEQ : FBB). All other care corresponds to routine care.
Florbetaben is used during pet scans to visualize beta amyloid plaques and cannot be a separate intervention in and of itself.
MRI scanDevice
Subjects will have an MRI scan at inclusion.
APO E genotypingBiological
Subjects will have APO (apolipoprotein) E genotyping if not already known.
| Study group | Role | What they receive |
|---|---|---|
| ACA with isolated hemosiderosis | Other | This group is composed of patients with amyloid cerebral angiopathy (ACA) with isolated hemosiderosis.
Intervention: Pet scan with FBB
Intervention: MRI scan
Intervention: APO E genotyping Receives: Device: Pet scan with FBB; Device: MRI scan; Biological: APO E genotyping |
| ACA with lobar hematoma(s) | Other | This group is composed of patients with amyloid cerebral angiopathy (ACA) with lobar hematoma(s).
Intervention: Pet scan with FBB
Intervention: MRI scan
Intervention: APO E genotyping Receives: Device: Pet scan with FBB; Device: MRI scan; Biological: APO E genotyping |
| Alzheimer's without ACA | Other | This group is composed of Alzheimer's type dementia without MRI signs in favor of amyloid cerebral angiopathy (ACA).
Intervention: Pet scan with FBB
Intervention: MRI scan
Intervention: APO E genotyping Receives: Device: Pet scan with FBB; Device: MRI scan; Biological: APO E genotyping |
| Healthy volunteers | Other | This group is composed of healthy volunteers.
Intervention: Pet scan with FBB
Intervention: MRI scan
Intervention: APO E genotyping Receives: Device: Pet scan with FBB; Device: MRI scan; Biological: APO E genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET scan with Florbetaben: Standardized Uptake Value Ratio
Measured: Day 0
Secondary outcomes (9)
On the reference MRI: the number of lobar hemorrhages
Measured: Day 0
On the reference MRI: the locations of lobar hemorrhages
Location is defined as choices from among the following: frontal-right; frontal-left; parietal-right; parietal-left; occipital-right; occipital-left; temporal-right; temporal-left.
Measured: Day 0
On the reference MRI: The presence/absence classification for superficial siderosis
The classification corresponds to one of the following: absence; focal (involving < 4 sulci); disseminated (involving 4 or more sulci).
Measured: Day 0
On the reference MRI: the locations of superficial siderosis
Location is defined as choices from among the following: frontal-right; frontal-left; parietal-right; parietal-left; occipital-right; occipital-left; temporal-right; temporal-left.
Measured: Day 0
On the reference MRI: the absolute quantitative count of microbleeds
Measured: Day 0
On the reference MRI: microbleed count category
The microbleed count category corresponds to one of the following: 0, 1, 2-4, >4.
Measured: Day 0
On the reference MRI: The predominant location of microbleeds
Measured: Day 0
On the reference MRI: a measure of leukoencephalopathy using the ARWMC scale
The age-related white matter changes (ARWMC) rating scale rating only the supratentorial white matter for each frontal, parieto-occipital, and temporal localisation: 0 for no lesions, 1 for focal lesions, 2 for beginning confluence of lesions, and 3 for diffuse involvement of the entire region
Measured: Day 0
Apolipoprotein E genotype
Everyone has two copies of the gene so the resulting combination determines your APOE "genotype" as one of the following: E2/E2, E2/E3, E2/E4, E3/E3, E3/E4, or E4/E4.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJul 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: experimental drug prohibited by the ANSM (French competent authority)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloid Cerebral AngiopathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dimitri Renard, MD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664571
- Sponsor's protocol ID
- LOCAL/2015/DM-01
- Other IDs
- 2015-004583-11, 2015
- Acronym
- FBB ACC
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2016
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis
- ClinicalTrials.gov ID
- NCT02664571
- Acronym / sponsor ID
- FBB ACC / LOCAL/2015/DM-01
- Conditions
- Amyloid Cerebral Angiopathy, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: experimental drug prohibited by the ANSM (French competent authority)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 27 Jan 2016 (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.
The main objective of this study is to compare the distribution of Florbetaben (NEURACEQ: FBB) in the brain in amyloid cerebral angiopathy (ACA) manifested by isolated hemosiderosis in non-demented patients with that observed in healthy subjects, patients with ACA and with lobar hematoma(s) and patients with Alzheimer's dementia without MRI signs in favor of ACA.
Detailed description
The secondary objectives of this study are to compare among groups:
- The associated micro-bleeds. B. Associated leukoencephalopathy. C. Contrast observed in lobar Virchow-Robin perivascular spaces. D. Apolipoprotein E genotypes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ACA with isolated hemosiderosis | Other | Device: Pet scan with FBB, Device: MRI scan, Biological: APO E genotypingThis group is composed of patients with amyloid cerebral angiopathy (ACA) with isolated hemosiderosis. Intervention: Pet scan with FBB Intervention: MRI scan Intervention: APO E genotyping |
| ACA with lobar hematoma(s) | Other | Device: Pet scan with FBB, Device: MRI scan, Biological: APO E genotypingThis group is composed of patients with amyloid cerebral angiopathy (ACA) with lobar hematoma(s). Intervention: Pet scan with FBB Intervention: MRI scan Intervention: APO E genotyping |
| Alzheimer's without ACA | Other | Device: Pet scan with FBB, Device: MRI scan, Biological: APO E genotypingThis group is composed of Alzheimer's type dementia without MRI signs in favor of amyloid cerebral angiopathy (ACA). Intervention: Pet scan with FBB Intervention: MRI scan Intervention: APO E genotyping |
| Healthy volunteers | Other | Device: Pet scan with FBB, Device: MRI scan, Biological: APO E genotypingThis group is composed of healthy volunteers. Intervention: Pet scan with FBB Intervention: MRI scan Intervention: APO E genotyping |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- The subject must have given his/her informed and signed consent
- The subject must be insured or beneficiary of a health insurance plan
- Healthy volunteers without cerebral neurological history and with normal MRI
- The subject is does not have dementia (Mini Mental State score> 27)
- Exclusion Criteria for patients with amyloid cerebral angiopathy with isolated hemosiderosis:
Key exclusion criteria (8 listed)
- The subject is participating in another interventional study
- The subject is in an exclusion period determined by a previous study
- The subject is under judicial protection
- The subject (next of kin or legal representative) refuses to sign the consent
- It is not possible to give the subject or his/her representative informed information
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 |
|---|---|---|
| Pet scan with FBBPatients will have a pet scan with Florbetaben (NEURACEQ : FBB). All other care corresponds to routine care. Florbetaben is used during pet scans to visualize beta amyloid plaques and cannot be a separate intervention in and of itself. | Device | ACA with isolated hemosiderosis, ACA with lobar hematoma(s), Alzheimer's without ACA, Healthy volunteers |
| MRI scanSubjects will have an MRI scan at inclusion. | Device | ACA with isolated hemosiderosis, ACA with lobar hematoma(s), Alzheimer's without ACA, Healthy volunteers |
| APO E genotypingSubjects will have APO (apolipoprotein) E genotyping if not already known. | Biological | ACA with isolated hemosiderosis, ACA with lobar hematoma(s), Alzheimer's without ACA, Healthy volunteers |
Primary outcome
PET scan with Florbetaben: Standardized Uptake Value Ratio
Time frame: Day 0
9 secondary outcomes
On the reference MRI: the number of lobar hemorrhages
Time frame: Day 0
On the reference MRI: the locations of lobar hemorrhages
Time frame: Day 0
On the reference MRI: The presence/absence classification for superficial siderosis
Time frame: Day 0
On the reference MRI: the locations of superficial siderosis
Time frame: Day 0
On the reference MRI: the absolute quantitative count of microbleeds
Time frame: Day 0
On the reference MRI: microbleed count category
Time frame: Day 0
On the reference MRI: The predominant location of microbleeds
Time frame: Day 0
On the reference MRI: a measure of leukoencephalopathy using the ARWMC scale
Time frame: Day 0
Apolipoprotein E genotype
Time frame: Day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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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.
Dimitri Renard, MD study director
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pet scan with FBB, MRI scan and APO E genotyping in people with Amyloid Cerebral Angiopathy and Alzheimer Disease, run by Centre Hospitalier Universitaire de Nīmes at 2 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 29 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: withdrawn, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
PET scan with Florbetaben: Standardized Uptake Value Ratio (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2021.