Cerebral Amyloid Imaging Using Florbetapir (AV-45)

Last updated: August 2, 2018
Sponsor: Centre Hospitalier Universitaire, Amiens
Overall Status: Active - Recruiting

Phase

3

Condition

Dementia

Treatment

N/A

Clinical Study ID

NCT02813434
PI2013_843_0011
  • Ages 40-80
  • All Genders

Study Summary

This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45) for the etiological diagnosis of poststroke cognitive impairment and dementia

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. patients suffering of parenchymal stroke visualized by imaging (MRI),

  2. patients suffering from cognitive impairment on the 6 months assessment (includingGRECogVASC patients),

  3. age between 40 and 80 years,

  4. French-speaking,

  5. reliable informant,

  6. agreeing to participate in the study,

  7. affiliation to a social security system,

Exclusion

Exclusion Criteria:

  1. women of childbearing potential (defined as pre-menopausal, less than 2 yearspostmenopausal, or not surgically sterile), or who are breast-feeding

  2. history of relevant severe drug allergy or hypersensitivity,

  3. patient receiving any investigational medications at least in the 30 last days,

  4. stroke affecting the cerebellum,

  5. mental retardation,

  6. illiteracy,

  7. dementia diagnosed before stroke,

  8. history of schizophrenia or psychiatric illness requiring a stay for > 2 days in apsychiatry unit,

  9. persons placed under judicial protection,

  10. comorbidities affecting cognition (respiratory, renal, liver, heart failure),

  11. persistent disturbance of consciousness defined by a score to item 1a of the NationalInstitute of Health Stroke Scale (NIHSS) ≤ 1,

  12. contraindication to MRI.

Study Design

Total Participants: 100
Study Start date:
September 01, 2014
Estimated Completion Date:
September 30, 2022

Study Description

This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45) for the etiological diagnosis of poststroke cognitive impairment and dementia. This study stems from two converging objectives: (1) the need to refine characteristics of vascular cognitive impairment (VCI) and dementia (VD) in order to propose diagnosis criteria of VCI and of mixed dementia and to improve diagnosis criteria of VD and (2) the need to improve the etiological diagnosis of poststroke cognitive impairment and dementia. It will take advantage from the ongoing GRECOG-VASC study (which determines the cognitive status 6 months poststroke in consecutive patients according to a standardized international battery) coordinated by the Amiens University Hospital center, the opportunity to perform amyloid imaging in vivo using Positron Emission Tomography (PET) and Florbetapir (a production site is located in the city of Amiens) and the collaboration between neurology and imaging departments of Amiens University hospital.

Connect with a study center

  • CHU Amiens

    Amiens, 80054
    France

    Active - Recruiting

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