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Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis (FBB ACC)

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ClinicalTrials.gov Identifier: NCT02664571
Recruitment Status : Withdrawn (experimental drug prohibited by the ANSM (French competent authority))
First Posted : January 27, 2016
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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Brief 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 Alzheimer's dementia without MRI signs in favor of ACA.

Condition or disease Intervention/treatment Phase
Amyloid Cerebral Angiopathy Alzheimer Disease Device: Pet scan with FBB Device: MRI scan Biological: APO E genotyping Not Applicable

Detailed Description:

The secondary objectives of this study are to compare among groups:

A. The associated micro-bleeds. B. Associated leukoencephalopathy. C. Contrast observed in lobar Virchow-Robin perivascular spaces. D. Apolipoprotein E genotypes.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arms and Interventions
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Arm Intervention/treatment
ACA with isolated hemosiderosis

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

 Device: Pet scan with FBB

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.


Device: MRI scan
Subjects will have an MRI scan at inclusion.

Biological: APO E genotyping
Subjects will have APO (apolipoprotein) E genotyping if not already known.
ACA with lobar hematoma(s)

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

 Device: Pet scan with FBB

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.


Device: MRI scan
Subjects will have an MRI scan at inclusion.

Biological: APO E genotyping
Subjects will have APO (apolipoprotein) E genotyping if not already known.
Alzheimer's without ACA

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

 Device: Pet scan with FBB

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.


Device: MRI scan
Subjects will have an MRI scan at inclusion.

Biological: APO E genotyping
Subjects will have APO (apolipoprotein) E genotyping if not already known.
Healthy volunteers

This group is composed of healthy volunteers.

Intervention: Pet scan with FBB

Intervention: MRI scan

Intervention: APO E genotyping

 Device: Pet scan with FBB

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.


Device: MRI scan
Subjects will have an MRI scan at inclusion.

Biological: APO E genotyping
Subjects will have APO (apolipoprotein) E genotyping if not already known.


Outcome Measures
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Primary Outcome Measures :
  1. PET scan with Florbetaben: Standardized Uptake Value Ratio [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. On the reference MRI: the number of lobar hemorrhages [ Time Frame: Day 0 ]
  2. On the reference MRI: the locations of lobar hemorrhages [ Time Frame: Day 0 ]
    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.

  3. On the reference MRI: The presence/absence classification for superficial siderosis [ Time Frame: Day 0 ]
    The classification corresponds to one of the following: absence; focal (involving < 4 sulci); disseminated (involving 4 or more sulci).

  4. On the reference MRI: the locations of superficial siderosis [ Time Frame: Day 0 ]
    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.

  5. On the reference MRI: the absolute quantitative count of microbleeds [ Time Frame: Day 0 ]
  6. On the reference MRI: microbleed count category [ Time Frame: Day 0 ]
    The microbleed count category corresponds to one of the following: 0, 1, 2-4, >4.

  7. On the reference MRI: The predominant location of microbleeds [ Time Frame: Day 0 ]
  8. On the reference MRI: a measure of leukoencephalopathy using the ARWMC scale [ Time Frame: Day 0 ]
    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

  9. Apolipoprotein E genotype [ Time Frame: Day 0 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for patients with amyloid cerebral angiopathy with isolated hemosiderosis:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient has a single or multiple focal spontaneous hemosiderosis objectified by an MRI
  • The patient is does not have dementia (Mini Mental State score> 27)

Inclusion Criteria for patients with amyloid cerebral angiopathy with with lobar hematoma(s):

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient has one or more spontaneous lobar hematomas with or without hemosiderosis objectified by an MRI
  • The patient is does not have dementia (Mini Mental State score> 27)

Inclusion Criteria for patients with Alzheimer's type dementia without MRI signs in favor of amyloid cerebral angiopathy:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient has Alzheimer's dementia (Mini Mental State score <24) without hemosiderosis or previous lobar hematoma or history of other brain lesion seen on MRI

Inclusion Criteria for health volunteers:

  • 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
  • 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

Exclusion Criteria for healthy volunteers:

  • 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.

Contacts and Locations
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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): NCT02664571


Locations
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France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
CH de Perpignan - Hôpital Saint Jean
Perpignan, France, 66046
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: Dimitri Renard, MD Centre Hospitalier Universitaire de Nîmes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02664571    
Other Study ID Numbers: LOCAL/2015/DM-01
2015-004583-11 ( EudraCT Number )
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Amyloidosis
Hemosiderosis
Plaque, Amyloid
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Proteostasis Deficiencies
Metabolic Diseases
Iron Overload
Iron Metabolism Disorders
Pathological Conditions, Anatomical