Cerebral Amyloid Imaging Using Florbetapir (AV-45) (IDEA3)

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

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

Study Overview

• Status: Unknown
• Conditions: Dementia; Cognition Disorders
• Intervention / Treatment: Biological: florbetapir

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Olivier GODEFROY, MD, PhD; Phone Number: +33 3 22 66 84 47; Email: godefroy.olivier@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens
    • Contact: Olivier GODEFROY, MD, PhD; Phone Number: +33 3 22 66 84 47; Email: godefroy.olivier@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Florbetapir	Biological: florbetapir; 18F-AV-45 or 18F-Florbetapir

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final diagnosis	cognitive impairment or dementia	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (ESTIMATE): June 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: 18F-AV-45; poststroke; Cerebral amyloid imaging; Florbetapir
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Cognition Disorders
• Other Study ID Numbers: PI2013_843_0011