Cerebral Amyloid Imaging Using Florbetapir (AV-45)
IDEA3
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2014
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedAugust 3, 2018
August 1, 2018
8 years
June 20, 2016
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Final diagnosis
12 months
Study Arms (1)
Florbetapir
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80054, France
Related Publications (1)
Godefroy O, Trinchard N, Marchal E, Lamy C, Canaple S, Meyer ME, Roussel M, Wollenweber FA; IDEA3 Study Group. Do Amyloid Cerebral Deposits Influence the Long-Term Poststroke Cognitive Outcome?: The IDEA3 Study. Stroke. 2025 Jan;56(1):74-83. doi: 10.1161/STROKEAHA.124.049147. Epub 2024 Dec 9.
PMID: 39648884DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier GODEFROY, MD, PhD
CHU Amiens
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2016
First Posted
June 27, 2016
Study Start
September 1, 2014
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
August 3, 2018
Record last verified: 2018-08