Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis
- Conditions
- Amyloid Cerebral AngiopathyAlzheimer Disease
- Interventions
- Device: Pet scan with FBBDevice: MRI scanBiological: APO E genotyping
- Registration Number
- NCT02664571
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACA with lobar hematoma(s) MRI scan 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 ACA with lobar hematoma(s) APO E genotyping 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 Healthy volunteers MRI scan This group is composed of healthy volunteers. Intervention: Pet scan with FBB Intervention: MRI scan Intervention: APO E genotyping ACA with isolated hemosiderosis Pet scan with FBB 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 Healthy volunteers APO E genotyping This group is composed of healthy volunteers. Intervention: Pet scan with FBB Intervention: MRI scan Intervention: APO E genotyping ACA with isolated hemosiderosis APO E genotyping 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 ACA with lobar hematoma(s) Pet scan with FBB 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 Alzheimer's without ACA MRI scan 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 Healthy volunteers Pet scan with FBB This group is composed of healthy volunteers. Intervention: Pet scan with FBB Intervention: MRI scan Intervention: APO E genotyping ACA with isolated hemosiderosis MRI scan 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 Alzheimer's without ACA Pet scan with FBB 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 Alzheimer's without ACA APO E genotyping 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
- Primary Outcome Measures
Name Time Method PET scan with Florbetaben: Standardized Uptake Value Ratio Day 0
- Secondary Outcome Measures
Name Time Method On the reference MRI: The presence/absence classification for superficial siderosis Day 0 The classification corresponds to one of the following: absence; focal (involving \< 4 sulci); disseminated (involving 4 or more sulci).
On the reference MRI: the number of lobar hemorrhages Day 0 On the reference MRI: the absolute quantitative count of microbleeds Day 0 On the reference MRI: The predominant location of microbleeds Day 0 On the reference MRI: the locations of superficial siderosis 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.
On the reference MRI: microbleed count category Day 0 The microbleed count category corresponds to one of the following: 0, 1, 2-4, \>4.
On the reference MRI: the locations of lobar hemorrhages 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.
On the reference MRI: a measure of leukoencephalopathy using the ARWMC scale 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
Apolipoprotein E genotype 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.
Trial Locations
- Locations (2)
CH de Perpignan - Hôpital Saint Jean
🇫🇷Perpignan, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France