Alzheimer Disease, Amyloid Cerebral Angiopathy
Conditions
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.
Interventions
DEVICEPet 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.
DEVICEMRI scan
Subjects will have an MRI scan at inclusion.
BIOLOGICALAPO E genotyping
Subjects will have APO (apolipoprotein) E genotyping if not already known.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PET scan with Florbetaben: Standardized Uptake Value Ratio | Day 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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 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: the absolute quantitative count of microbleeds | Day 0 | — |
| On the reference MRI: the number of lobar hemorrhages | 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 | 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. |
| On the reference MRI: microbleed count category | Day 0 | The microbleed count category corresponds to one of the following: 0, 1, 2-4, \>4. |
Countries
France
Outcome results
None listed