Cerebral Amyloid Imaging Using Florbetapir (AV-45)

Dementia Clinical Trial

— IDEA3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02813434
• Other study ID #: PI2013_843_0011
• Status: Recruiting
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: September 2022

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Olivier Godefroy, MD, PhD
• Phone: +33 3 22 66 84 47
• Email: godefroy.olivier[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Dementia

Intervention

Biological:
• florbetapir
18F-AV-45 or 18F-Florbetapir

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Final diagnosis	cognitive impairment or dementia	12 months