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

Centre Hospitalier Universitaire, Amiens

Status and phase: Unknown; Phase 3

Conditions: Cognition Disorders; Dementia

Treatments: Biological: florbetapir

Study type: Interventional

Funder types: Other

Identifiers

NCT02813434

PI2013_843_0011

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Florbetapir

Experimental group

Treatment:

Biological: florbetapir