DementiaPhase 3IDEA3NCT02813434
Cerebral Amyloid Imaging Using Florbetapir (AV-45)
A Phase 3 study testing florbetapir in people with Dementia and Cognition Disorders, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Dementia, Cognition Disorders
- What is being tested?
- florbetapir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2014to 7 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Amyloid Imaging Using Florbetapir (18F-AV-45) for the Etiological Diagnosis of Poststroke Cognitive Impairment and Dementia
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
Read the 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.
- Conditions
- Dementia, Cognition Disorders
- Being tested
- florbetapir
- Keywords
- Cerebral amyloid imaging, Florbetapir, 18F-AV-45, poststroke
- Medical subject headings
- Dementia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
florbetapirBiological
18F-AV-45 or 18F-Florbetapir
| Study group | Role | What they receive |
|---|---|---|
| Florbetapir | Experimental | Not described Receives: Biological: florbetapir |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of positive amyloid retention
determine the frequency of abnormal amyloid retention using PET with 18F-AV-45 on patients with poststroke cognitive impairment
Measured: 12 months
Secondary outcomes (1)
Final diagnosis
cognitive impairment or dementia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start24 Sep 2014
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GODEFROY, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813434
- Sponsor's protocol ID
- PI2013_843_0011
- Acronym
- IDEA3
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2016
- Last updated
- 11 Jun 2026
- Results posted
- No
Publications
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.
PubMed 39648884
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Amyloid Imaging Using Florbetapir (18F-AV-45) for the Etiological Diagnosis of Poststroke Cognitive Impairment and Dementia
- ClinicalTrials.gov ID
- NCT02813434
- Acronym / sponsor ID
- IDEA3 / PI2013_843_0011
- Conditions
- Dementia, Cognition Disorders
- Keywords
- Cerebral amyloid imaging, Florbetapir, 18F-AV-45, poststroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 24 Sep 2014 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Florbetapir | Experimental | Biological: florbetapir |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| florbetapir18F-AV-45 or 18F-Florbetapir | Biological | Florbetapir |
Primary outcome
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
1 secondary outcome
Final diagnosis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Derived from this study: PubMed 39648884Godefroy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier GODEFROY, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing florbetapir in people with Dementia and Cognition Disorders, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of positive amyloid retention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.