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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Evaluation of Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis

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 Summary:

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.


Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome: PET scan with Florbetaben: Standardized Uptake Value Ratio [ Time Frame: Day 0 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • On the reference MRI: the number of lobar hemorrhages [ Time Frame: Day 0 ]
  • On the reference MRI: the locations of lobar hemorrhages [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 0 ]
  • On the reference MRI: microbleed count category [ Time Frame: Day 0 ]
    The microbleed count category corresponds to one of the following: 0, 1, 2-4, >4.
  • On the reference MRI: The predominant location of microbleeds [ Time Frame: Day 0 ]
  • On the reference MRI: a measure of leukoencephalopathy using the ARWMC scale [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: January 19, 2016
Date Started: March 2017
Date Completion: September 2017
Last Updated: August 29, 2016
Last Verified: August 2016