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

Alzheimer Disease Clinical Trial

— FBB ACC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02664571
• Other study ID #: LOCAL/2015/DM-01
• Secondary ID: 2015-004583-11
• Status: Withdrawn
• Phase: N/A
• Start date: July 2020
• Est. completion date: July 2021

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Alzheimer's dementia without MRI signs in favor of ACA.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Amyloid Cerebral Angiopathy
• Amyloidosis
• Hemosiderosis
• Plaque, Amyloid

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	CH de Perpignan - Hôpital Saint Jean	Perpignan

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET scan with Florbetaben: Standardized Uptake Value Ratio		Day 0
Secondary	On the reference MRI: the number of lobar hemorrhages		Day 0
Secondary	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.	Day 0
Secondary	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).	Day 0
Secondary	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.	Day 0
Secondary	On the reference MRI: the absolute quantitative count of microbleeds		Day 0
Secondary	On the reference MRI: microbleed count category	The microbleed count category corresponds to one of the following: 0, 1, 2-4, >4.	Day 0
Secondary	On the reference MRI: The predominant location of microbleeds		Day 0
Secondary	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	Day 0
Secondary	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.	Day 0