Clinical trial NCT02664571: Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis
Official title: Evaluation of Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Amyloid Cerebral Angiopathy
Alzheimer Disease
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: PET scan with Florbetaben: Standardized Uptake Value Ratio
timeFrame: Day 0
Secondary outcomes:
measure: On the reference MRI: the number of lobar hemorrhages
timeFrame: Day 0
measure: On the reference MRI: the locations of lobar hemorrhages
timeFrame: Day 0
measure: On the reference MRI: The presence/absence classification for superficial siderosis
timeFrame: Day 0
measure: On the reference MRI: the locations of superficial siderosis
timeFrame: Day 0
measure: On the reference MRI: the absolute quantitative count of microbleeds
timeFrame: Day 0
measure: On the reference MRI: microbleed count category
timeFrame: Day 0
measure: On the reference MRI: The predominant location of microbleeds
timeFrame: Day 0
measure: On the reference MRI: a measure of leukoencephalopathy using the ARWMC scale
timeFrame: Day 0
measure: Apolipoprotein E genotype
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Perpignan
country: France
facility: CH de Perpignan - Hôpital Saint Jean
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Dimitri Renard, MD
role: STUDY_DIRECTOR
References: