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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT02813434

Collaborator

(none)

100

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dementia Cognition Disorders	Biological: florbetapir	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Florbetapir	Biological: florbetapir 18F-AV-45 or 18F-Florbetapir

Arm

Intervention/Treatment

Experimental: Florbetapir

Biological: florbetapir

18F-AV-45 or 18F-Florbetapir

Outcome Measures

Primary Outcome Measures

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

Final diagnosis [12 months]
cognitive impairment or dementia

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.