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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813434
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2014
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis Dementia

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




Primary Outcome Measures :
  1. presence of positive amyloid retention [ Time Frame: 12 months ]
    determine the frequency of abnormal amyloid retention using PET with 18F-AV-45 on patients with poststroke cognitive impairment


Secondary Outcome Measures :
  1. Final diagnosis [ Time Frame: 12 months ]
    cognitive impairment or dementia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813434


Contacts
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Contact: Olivier Godefroy, MD, PhD +33 3 22 66 84 47 godefroy.olivier@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Olivier GODEFROY, MD, PhD    +33 3 22 66 84 47    godefroy.olivier@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Olivier GODEFROY, MD, PhD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02813434    
Other Study ID Numbers: PI2013_843_0011
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Cerebral amyloid imaging
Florbetapir
18F-AV-45
poststroke
Additional relevant MeSH terms:
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Dementia
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders