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Clinical Trials/NCT02664571
NCT02664571WithdrawnNot Applicable

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

Centre Hospitalier Universitaire de Nīmes4 sites in 1 countryStarted: July 1, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
4
Primary Endpoint
PET scan with Florbetaben: Standardized Uptake Value Ratio
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts 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)
  • •Exclusion Criteria for patients with amyloid cerebral angiopathy with with lobar hematoma(s):
  • •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)
  • •Exclusion Criteria fpr patients with Alzheimer's type dementia without MRI signs in favor of amyloid cerebral angiopathy:
  • •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)
  • •Haemosiderosis or history of lobar hematoma or other visible cerebral history on MRI
  • •Exclusion Criteria for healthy volunteers:
  • •The subject is participating in another interventional study
  • •The subject is in an exclusion period determined by a previous study
  • •The subject 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 subject has an contra-indication for performing an MRI
  • •Abnormal MRI
  • •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.

Outcomes

Primary Outcomes

PET scan with Florbetaben: Standardized Uptake Value Ratio

Time Frame: Day 0

Secondary Outcomes

  • On the reference MRI: The presence/absence classification for superficial siderosis(Day 0)
  • 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)
  • On the reference MRI: microbleed count category(Day 0)
  • On the reference MRI: the locations of lobar hemorrhages(Day 0)
  • On the reference MRI: a measure of leukoencephalopathy using the ARWMC scale(Day 0)
  • Apolipoprotein E genotype(Day 0)

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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