At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 218 enrolled

Drug / intervention

Neuraceq (florbetaben 18F) +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02681172

NCT02681172Phase 4Completed

Compare CT.gov

Multicenter Study to Explore the Impact of Florbetaben (FBB) in Change of Diagnosis in Patients Who Are Evaluated for AD and in Whom Lumbar Puncture is Contraindicated or CSF Results Are Ambiguous

Piramal Imaging Limited·interventional·Posted Feb 12, 2016·Updated Nov 2, 2018

In Brief

A Phase 4 clinical trial evaluating Neuraceq (florbetaben 18F) and PET for Alzheimer's Disease (AD). Completed, enrolled 218 participants across 1 site.

Detailed Summary

This phase 4 study will explore, in the context of the present French clinical practice, the impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for etiologic determination of the cognitive and functional impairment, but in whom: 1. lumbar puncture was not feasible for medical conditions 2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians 3. lumbar puncture (LP) was refused by the patient

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAlzheimer's Disease (AD)

CountriesFrance

Collaborators--

Timeline

Phase 4CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartOct 2015

First PostedFeb 2016

Primary CompletionSep 2016

Study CompletionNov 2016

TodayJul 2026

First PostedFeb 12, 2016

Enrollment StartOct 1, 2015

Primary CompletionSep 1, 2016

Study CompletionNov 1, 2016

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 10.4 years ago

Interventions

Neuraceq (florbetaben 18F)drug

Florbetaben 18F is given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose.

PETprocedure

A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.