Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004583-11 | EudraCT Number |
Not provided
Not provided
experimental drug prohibited by the ANSM (French competent authority)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACA with isolated hemosiderosis | Other | 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) | Other | 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 | Other | 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 | Other | This group is composed of healthy volunteers. Intervention: Pet scan with FBB Intervention: MRI scan Intervention: APO E genotyping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pet scan with FBB | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PET scan with Florbetaben: Standardized Uptake Value Ratio | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| On the reference MRI: the number of lobar hemorrhages | Day 0 | |
| 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. |
Not provided
Inclusion Criteria for patients with amyloid cerebral angiopathy with isolated hemosiderosis:
Inclusion Criteria for patients with amyloid cerebral angiopathy with with lobar hematoma(s):
Inclusion Criteria for patients with Alzheimer's type dementia without MRI signs in favor of amyloid cerebral angiopathy:
Inclusion Criteria for health volunteers:
Exclusion Criteria for patients with amyloid cerebral angiopathy with isolated hemosiderosis:
Exclusion Criteria for patients with amyloid cerebral angiopathy with with lobar hematoma(s):
Exclusion Criteria fpr patients with Alzheimer's type dementia without MRI signs in favor of amyloid cerebral angiopathy:
Exclusion Criteria for healthy volunteers:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dimitri Renard, MD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France | |||
| CH de Perpignan - Hôpital Saint Jean |
Not provided
Not provided
Not provided
Not provided
Not provided
| MRI scan | Device | Subjects will have an MRI scan at inclusion. |
|
| APO E genotyping | Biological | Subjects will have APO (apolipoprotein) E genotyping if not already known. |
|
| Day 0 |
| 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 |
| 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 |
| On the reference MRI: the absolute quantitative count of microbleeds | Day 0 |
| On the reference MRI: microbleed count category | The microbleed count category corresponds to one of the following: 0, 1, 2-4, >4. | Day 0 |
| On the reference MRI: The predominant location of microbleeds | Day 0 |
| 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 |
| 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 |
| Perpignan |
| 66046 |
| France |
| ID | Term |
|---|---|
| D016657 | Cerebral Amyloid Angiopathy |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003704 | Dementia |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
Not provided
Not provided