Impact of florbetaben, an imaging marker of Alzheimer's disease, in change of diagnosis in patients who attend a memory clinic (CMRR) for memory decline, in whom the analysis of the biomarkers of the disease in the cerebro-spinal fluid is recommended to support the diagnosis, but in whom these biomarkers cannot be collected or evaluated

Multicenter study to explore the impact of florbetaben (FBB) in change of diagnosis in patients who are evaluated for AD at the CMRR, and are eligible for analysis of CSF according to HAS recommendations, and in whom lumbar puncture is contraindicated or CSF results are ambiguous.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002606-37-FR

Enrollment

207

Registered

2015-08-06

Start date

2015-09-24

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Interventions

Trade Name: Neuraceq Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female subjects =65 years) yes F.1.3.1 Number of subjects for this age range 197

Exclusion criteria

Exclusion criteria: 1. The subject had a previous beta amyloid imaging scan 2. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol 3. Is currently receiving any investigational pharmaceutical product or has participated in a clinical trial with an investigational pharmaceutical product within 30 days prior to screening and/or was administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To estimate the change in diagnosis comparing pre- and post-scan outcomes in the study population;Secondary Objective: Physician confidence: Confidence Assessment scale - change in confidence Number of positive and negative scans: Percentage of negative scans Percentage of positive scans Description of the study population: Gender, Age, Education, LP refused, LP not feasible, CSF ambiguous, Clinical Profile ;Primary end point(s): to explore the impact of florbetaben PET imaging in change of diagnosis in patients with dementia for whom collection of biomarkers is required ;Timepoint(s) of evaluation of this end point: after florbetaben PET imaging results disclosure	—

Measure

Time frame

Main Objective: To estimate the change in diagnosis comparing pre- and post-scan outcomes in the study population;Secondary Objective: Physician confidence: Confidence Assessment scale - change in confidence Number of positive and negative scans: Percentage of negative scans Percentage of positive scans Description of the study population: Gender, Age, Education, LP refused, LP not feasible, CSF ambiguous, Clinical Profile ;Primary end point(s): to explore the impact of florbetaben PET imaging in change of diagnosis in patients with dementia for whom collection of biomarkers is required ;Timepoint(s) of evaluation of this end point: after florbetaben PET imaging results disclosure

—

Secondary

Measure	Time frame
Secondary end point(s): change in level physician confidence pre and post florbetaben PET imaging, number of subjects with a positive scan and number of subjects with a negative scan, description of reason for inclusion in the trial (LP refused or not performed, CSF results ambiguous) ;Timepoint(s) of evaluation of this end point: Screening visit and final visit	—

Countries

France

Contacts

Public ContactSouth West Europe Medical Affairs

Piramal Imaging Ltd

rossella.gismondi@piramal.com4930461124615

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026