Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis

NCT ID: NCT02664571

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2021-07-31

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.

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.

Conditions

Amyloid Cerebral Angiopathy; Alzheimer Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: OTHER

Pet scan with FBB

Intervention Type: DEVICE

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 scan

Intervention Type: DEVICE

Subjects will have an MRI scan at inclusion.

APO E genotyping

Intervention Type: BIOLOGICAL

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

Group Type: OTHER

Pet scan with FBB

Intervention Type: DEVICE

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 scan

Intervention Type: DEVICE

Subjects will have an MRI scan at inclusion.

APO E genotyping

Intervention Type: BIOLOGICAL

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

Group Type: OTHER

Pet scan with FBB

Intervention Type: DEVICE

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 scan

Intervention Type: DEVICE

Subjects will have an MRI scan at inclusion.

APO E genotyping

Intervention Type: BIOLOGICAL

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

Group Type: OTHER

Pet scan with FBB

Intervention Type: DEVICE

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 scan

Intervention Type: DEVICE

Subjects will have an MRI scan at inclusion.

APO E genotyping

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: DEVICE

MRI scan

Subjects will have an MRI scan at inclusion.

Intervention Type: DEVICE

APO E genotyping

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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)

• 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)

• 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

• 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

• 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)

• 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)

• 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

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitri Renard, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

CH de Perpignan - Hôpital Saint Jean

Perpignan, , France

Countries

France

Other Identifiers

2015-004583-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LOCAL/2015/DM-01

Identifier Type: -

Identifier Source: org_study_id