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

March 15, 2018 updated by: Piramal Imaging Limited

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It will be conducted in an outpatient setting at the tertiary memory clinics (CMRR) in France in patients with a preliminary diagnosis based on the completion of a prior, full diagnostic workup, not more than 12 months previously - which could include, but will not be limited to brain imaging if needed (magnetic resonance imaging (MRI) or computed tomography (CT)), neuropsychological evaluation including a Mini-Mental Status Examination (MMSE), CSF examination and other examinations according to "Haute Autorité de santé" (HAS, National Authority of Health, France) Recommendations - and 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

For all subjects the study will comprise 3 outpatient clinic visits to record information on previous work ups and to perform the FBB Positron Emission Tomography (PET) scan (Visit 1: screening/ baseline, Visit 2: PET scan, Visit 3: subject informed on the FBB PET scan result).

At Visit 1, the initial diagnosis based on previous work up will be collected and rated on a five-point Likert confidence scale by the Physician.

At Visit 2, the FBB PET scan will be performed. Adverse events will be reported during the exam and up to 7 days after the PET procedure.

At Visit 3, based on the amyloid PET scan results, change of diagnosis will be collected, in addition to physician confidence.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13385
        • Coordinating center (Hôpital de La Timone) and 18 associated centers in France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients being evaluated for Alzheimer disease and related dementias according to the HAS recommendations (atypical dementia, early onset and rapid progressive dementia)
  • Patients who have previously been evaluated for AD and related dementias to whom a CSF examination was recommended in the last 12 months, but lumbar puncture was contraindicated or refused or CSF results were ambiguous, or
  • Patients currently being evaluated for AD and related dementias to whom a CSF examination is recommended but lumbar puncture is contraindicated or refused
  • Patients have a study partner who is willing and able to accompany him/her to all clinic visits for the duration of the protocol
  • Patients able to complete all clinical visits according to the protocol
  • Patients able to tolerate a 20-minute FBB PET scan
  • Patient or legal representative to provide informed consent for study participation, visits and data source verification.

Exclusion Criteria:

  • The subject had a previous beta amyloid imaging scan
  • Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
  • 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
  • For females of childbearing age, a positive pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuraceq (florbetaben 18F) PET scan

A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq will be administered per subject.

The applied florbetaben radioactive dose will be ± 20%.
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.
Other Names:
  • FBB
Procedure: PET
A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.
Other Names:
  • Positron Emission Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes
Time Frame: Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)
The Physician's diagnosis was assessed before and after FBB PET scan. The initial Physician's diagnosis was collected before the PET scan, at Visit 1, based on key diagnostic results of current or previous workup. After the PET scan, the final Physician's diagnosis was collected at Visit 3, based on the amyloid PET scan results.
Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Improved Level of Physician Confidence in Diagnosis at Visit 3
Time Frame: Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)
The Physician's diagnostic confidence was rated on a five-point Likert scale before and after FBB PET scan. Likert scales consisted of the categories: "very weak", "weak", "moderate", "high", and "very high".
Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)
Number of Participants With a Change of Management Plan Comparing Pre- and Post-scan Outcomes
Time Frame: Visit 1 (baseline evaluation) and Visit 3 (up to 3 months later)
For all subjects, concomitant medications were reported and any change of the management plan (e.g. new medications initiated, medications withdrawn, additional diagnostic tests ordered, referred to another specialist) was noted.
Visit 1 (baseline evaluation) and Visit 3 (up to 3 months later)
Number of Subjects With Positive FBB PET Scan
Time Frame: Visit 3 (up to 6 months after baseline evaluation)
PET image interpretation was performed locally in each centre by readers who had undergone training for appropriate interpretation of scans. Scans were interpreted as either "positive" or "negative" according to the approved visual assessment method.
Visit 3 (up to 6 months after baseline evaluation)
Number of Subjects With Negative FBB PET Scans
Time Frame: Visit 3 (up to 6 months after baseline evaluation)
PET image interpretation was performed locally in each centre by readers who had undergone training for appropriate interpretation of scans. Scans were interpreted as either "positive" or "negative" according to the approved visual assessment method.
Visit 3 (up to 6 months after baseline evaluation)
Number of Subjects With Contraindicated or Failed Lumbar Puncture
Time Frame: Visit 1 (baseline evaluation)
Number of subjects with contraindicated or failed LP (anticoagulant therapy, thrombocytopenia, lumbar puncture failed, spinal problems)
Visit 1 (baseline evaluation)
Number of Subjects With Available CSF Analysis But Results Considered as Non-contributory by the Clinician
Time Frame: Visit 1 (baseline evaluation)
Non-contributory CSF results (ambiguous CSF result, CSF result inconsistent with clinical information, uninterpretable CSF result for technical reasons)
Visit 1 (baseline evaluation)
Number of Subjects Who Refused Lumbar Puncture.
Time Frame: Visit 1 (baseline evaluation)
Visit 1 (baseline evaluation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Piramal Imaging Limited

Investigators

  • Principal Investigator: Mathieu Ceccaldi, Prof. MD., Hôpital de la Timone, Marseille, France
  • Principal Investigator: Eric Guedj, Prof., Hôpital de la Timone, Marseille, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FBB_01_02_2015
  • 2015-002606-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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