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

Not Applicable

Withdrawn

• Conditions: Amyloid Cerebral Angiopathy; Alzheimer Disease

• 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.

Study Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Study Start: 2020-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-25
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France

CH de Perpignan - Hôpital Saint Jean; 🇫🇷 Perpignan, France