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

Primary Purpose

Dementia, Cognition Disorders

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
florbetapir
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dementia focused on measuring Cerebral amyloid imaging, Florbetapir, 18F-AV-45, poststroke

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Florbetapir

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Final diagnosis
cognitive impairment or dementia

Full Information

First Posted
June 20, 2016
Last Updated
August 2, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02813434
Brief Title
Cerebral Amyloid Imaging Using Florbetapir (AV-45)
Acronym
IDEA3
Official Title
Cerebral Amyloid Imaging Using Florbetapir (18F-AV-45) for the Etiological Diagnosis of Poststroke Cognitive Impairment and Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Cognition Disorders
Keywords
Cerebral amyloid imaging, Florbetapir, 18F-AV-45, poststroke

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Florbetapir
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
florbetapir
Intervention Description
18F-AV-45 or 18F-Florbetapir
Primary Outcome Measure Information:
Title
presence of positive amyloid retention
Description
determine the frequency of abnormal amyloid retention using PET with 18F-AV-45 on patients with poststroke cognitive impairment
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Final diagnosis
Description
cognitive impairment or dementia
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Godefroy, MD, PhD
Phone
+33 3 22 66 84 47
Email
godefroy.olivier@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier GODEFROY, MD, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier GODEFROY, MD, PhD
Phone
+33 3 22 66 84 47
Email
godefroy.olivier@chu-amiens.fr

12. IPD Sharing Statement

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Cerebral Amyloid Imaging Using Florbetapir (AV-45)

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