NCT02681172

Brief 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. 1.lumbar puncture was not feasible for medical conditions
  2. 2.results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians
  3. 3.lumbar puncture (LP) was refused by the patient

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 2, 2018

Completed
Last Updated

November 2, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

February 4, 2016

Results QC Date

August 16, 2017

Last Update Submit

March 15, 2018

Conditions

Alzheimer's Disease (AD)

Keywords

CSFAlzheimer's Disease (AD) and related dementiaHAS recommendations

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes

    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 Outcomes (7)

  • Number of Subjects With Improved Level of Physician Confidence in Diagnosis at Visit 3

    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

    Visit 1 (baseline evaluation) and Visit 3 (up to 3 months later)

  • Number of Subjects With Positive FBB PET Scan

    Visit 3 (up to 6 months after baseline evaluation)

  • Number of Subjects With Negative FBB PET Scans

    Visit 3 (up to 6 months after baseline evaluation)

  • Number of Subjects With Contraindicated or Failed Lumbar Puncture

    Visit 1 (baseline evaluation)

  • +2 more secondary outcomes

Study Arms (1)

Neuraceq (florbetaben 18F) PET scan

EXPERIMENTAL

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)Procedure: PET

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.

Also known as: FBB
Neuraceq (florbetaben 18F) PET scan
PETPROCEDURE

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

Also known as: Positron Emission Tomography
Neuraceq (florbetaben 18F) PET scan

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coordinating center (Hôpital de La Timone) and 18 associated centers in France

Marseille, 13385, France

Location

Related Publications (1)

  • Ceccaldi M, Jonveaux T, Verger A, Krolak-Salmon P, Houzard C, Godefroy O, Shields T, Perrotin A, Gismondi R, Bullich S, Jovalekic A, Raffa N, Pasquier F, Semah F, Dubois B, Habert MO, Wallon D, Chastan M, Payoux P; NEUUS in AD study group; Stephens A, Guedj E. Added value of 18F-florbetaben amyloid PET in the diagnostic workup of most complex patients with dementia in France: A naturalistic study. Alzheimers Dement. 2018 Mar;14(3):293-305. doi: 10.1016/j.jalz.2017.09.009. Epub 2017 Nov 4.

    PMID: 29107051DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbeneMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Dr. Juergen Hirschfeld, Head of GRA & PV
Organization
Piramal Imaging
Juergen.Hirschfeld@piramal.com
+49 30461124615

Study Officials

  • Mathieu Ceccaldi, Prof. MD.

    Hôpital de La Timone, Marseille, France

    PRINCIPAL INVESTIGATOR

  • Eric Guedj, Prof.

    Hôpital de la Timone, Marseille, France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 12, 2016

Study Start

October 1, 2015

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

November 2, 2018

Results First Posted

November 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)