Cerebral Amyloid Imaging Using Florbetapir (AV-45)

Phase 3

• Conditions: Dementia; Cognition Disorders
• Interventions: Biological: florbetapir

• Registration Number: NCT02813434
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. patients suffering of parenchymal stroke visualized by imaging (MRI),
2. patients suffering from cognitive impairment on the 6 months assessment (including GRECogVASC 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 Criteria

1. women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, 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 a psychiatry 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 National Institute of Health Stroke Scale (NIHSS) ≤ 1,
12. contraindication to MRI.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Florbetapir	florbetapir	-

Primary Outcome Measures

Name	Time	Method
presence of positive amyloid retention	12 months	determine the frequency of abnormal amyloid retention using PET with 18F-AV-45 on patients with poststroke cognitive impairment

Secondary Outcome Measures

Name	Time	Method
Final diagnosis	12 months	cognitive impairment or dementia

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France