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

Centre Hospitalier Universitaire de Nīmes

Status: Withdrawn

Conditions: Amyloid Cerebral Angiopathy; Alzheimer Disease

Treatments: Biological: APO E genotyping; Device: MRI scan; Device: Pet scan with FBB

Study type: Interventional

Funder types: Other

Identifiers

NCT02664571

2015-004583-11 (EudraCT Number)

LOCAL/2015/DM-01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

ACA with isolated hemosiderosis

Other group

Description:

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

Treatment:

Biological: APO E genotyping

Device: Pet scan with FBB

Device: MRI scan

ACA with lobar hematoma(s)

Other group

Description:

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

Treatment:

Biological: APO E genotyping

Device: Pet scan with FBB

Device: MRI scan

Alzheimer's without ACA

Other group

Description:

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

Treatment:

Biological: APO E genotyping

Device: Pet scan with FBB

Device: MRI scan

Healthy volunteers

Other group

Description:

This group is composed of healthy volunteers. Intervention: Pet scan with FBB Intervention: MRI scan Intervention: APO E genotyping

Treatment:

Biological: APO E genotyping

Device: Pet scan with FBB

Device: MRI scan