Skip to main content
OpenTrials
Completed

NCT Number: NCT02813434

Cerebral Amyloid Imaging Using Florbetapir (AV-45)

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens

Amiens, 80054, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients suffering of parenchymal stroke visualized by imaging (MRI),
  • patients suffering from cognitive impairment on the 6 months assessment (including GRECogVASC patients),
  • age between 40 and 80 years,
  • French-speaking,
  • reliable informant,
  • agreeing to participate in the study,
  • affiliation to a social security system,

Exclusion criteria

  • women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile), or who are breast-feeding
  • history of relevant severe drug allergy or hypersensitivity,
  • patient receiving any investigational medications at least in the 30 last days,
  • stroke affecting the cerebellum,
  • mental retardation,
  • illiteracy,
  • dementia diagnosed before stroke,
  • history of schizophrenia or psychiatric illness requiring a stay for > 2 days in a psychiatry unit,
  • persons placed under judicial protection,
  • comorbidities affecting cognition (respiratory, renal, liver, heart failure),
  • persistent disturbance of consciousness defined by a score to item 1a of the National Institute of Health Stroke Scale (NIHSS) ≤ 1,
  • contraindication to MRI.

Treatment and study plan

florbetapir

Biological

18F-AV-45 or 18F-Florbetapir

Primary outcomes

  1. presence of positive amyloid retention

    Time frame: 12 months

    determine the frequency of abnormal amyloid retention using PET with 18F-AV-45 on patients with poststroke cognitive impairment

Secondary outcomes

  1. Final diagnosis

    Time frame: 12 months

    cognitive impairment or dementia

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Cerebral Amyloid Imaging Using Florbetapir (18F-AV-45) for the Etiological Diagnosis of Poststroke Cognitive Impairment and Dementia

Acronym: IDEA3

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2016
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.