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Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD

NCT02681172 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2018-11-02

Study results available
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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

Conditions

  • Alzheimer's Disease (AD)

Interventions

DRUG

Neuraceq (florbetaben 18F)

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

PROCEDURE

PET

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

Sponsors & Collaborators

  • Piramal Imaging Limited

    lead INDUSTRY

Principal Investigators

  • Mathieu Ceccaldi, Prof. MD. · Hôpital de La Timone, Marseille, France

  • Eric Guedj, Prof. · Hôpital de la Timone, Marseille, France

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-09-30
Completion
2016-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02681172 on ClinicalTrials.gov