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

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ClinicalTrials.gov Identifier: NCT02681172
Recruitment Status : Completed
First Posted : February 12, 2016
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging Limited

Tracking Information
First Submitted Date  ICMJE February 4, 2016
First Posted Date  ICMJE February 12, 2016
Results First Submitted Date  ICMJE August 16, 2017
Results First Posted Date  ICMJE November 2, 2018
Last Update Posted Date November 2, 2018
Study Start Date  ICMJE October 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
Change of diagnosis comparing pre- and post-scan outcomes [ Time Frame: baseline and 6 months ]
The Physician's diagnosis will be assessed before and after FBB PET scan. The initial Physician's diagnosis will be 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 will be collected at Visit 3, based on the amyloid PET scan results.
Change History Complete list of historical versions of study NCT02681172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
  • 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".
  • 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.
  • 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.
  • 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.
  • 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)
  • 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)
  • Number of Subjects Who Refused Lumbar Puncture. [ Time Frame: Visit 1 (baseline evaluation) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
  • Change in level of physician confidence in diagnosis [ Time Frame: baseline and 6 months ]
    The Physician's diagnostic confidence will be rated on a five-point Likert scale before and after FBB PET scan.
  • Percentage of subjects with Lumbar Puncture (LP) not feasible due to medical condition [ Time Frame: baseline ]
  • Percentage of subjects with ambiguous CSF result [ Time Frame: baseline ]
  • Mean age of subjects [ Time Frame: baseline ]
  • Number of subjects with positive FBB PET scan [ Time Frame: 6 months ]
  • Number of Subjects With Negative FBB PET Scans [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: February 9, 2016)
Number of subjects with adverse events [ Time Frame: up to 7 days post-injection ]
 
Descriptive Information
Brief Title  ICMJE Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD
Official Title  ICMJE 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
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. 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Alzheimer's Disease (AD)
Intervention  ICMJE
  • 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 Name: FBB
  • Procedure: PET
    A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.
    Other Name: Positron Emission Tomography
Study Arms  ICMJE 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%.

Interventions:
  • Drug: Neuraceq (florbetaben 18F)
  • Procedure: PET
Publications * 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 (18)F-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2016)
218
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2016)
207
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02681172
Other Study ID Numbers  ICMJE FBB_01_02_2015
2015-002606-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Piramal Imaging Limited
Study Sponsor  ICMJE Piramal Imaging Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mathieu Ceccaldi, Prof. MD. Hôpital de La Timone, Marseille, France
Principal Investigator: Eric Guedj, Prof. Hôpital de la Timone, Marseille, France
PRS Account Piramal Imaging Limited
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP