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

Primary Purpose

Alzheimer's Disease (AD)

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Neuraceq (florbetaben 18F)
PET
Sponsored by
Piramal Imaging Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer's Disease (AD) focused on measuring CSF, Alzheimer's Disease (AD) and related dementia, HAS recommendations

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuraceq (florbetaben 18F) PET scan

Arm Description

A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq will be administered per subject. The applied florbetaben radioactive dose will be ± 20%.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 4, 2016
Last Updated
March 15, 2018
Sponsor
Piramal Imaging Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02681172
Brief Title
Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Piramal Imaging Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: lumbar puncture was not feasible for medical conditions results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians 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: lumbar puncture was not feasible for medical conditions results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease (AD)
Keywords
CSF, Alzheimer's Disease (AD) and related dementia, HAS recommendations

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuraceq (florbetaben 18F) PET scan
Arm Type
Experimental
Arm Description
A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq will be administered per subject. The applied florbetaben radioactive dose will be ± 20%.
Intervention Type
Drug
Intervention Name(s)
Neuraceq (florbetaben 18F)
Other Intervention Name(s)
FBB
Intervention Description
Florbetaben 18F is given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose.
Intervention Type
Procedure
Intervention Name(s)
PET
Other Intervention Name(s)
Positron Emission Tomography
Intervention Description
A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.
Primary Outcome Measure Information:
Title
Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes
Description
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.
Time Frame
Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)
Secondary Outcome Measure Information:
Title
Number of Subjects With Improved Level of Physician Confidence in Diagnosis at Visit 3
Description
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".
Time Frame
Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)
Title
Number of Participants With a Change of Management Plan Comparing Pre- and Post-scan Outcomes
Description
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.
Time Frame
Visit 1 (baseline evaluation) and Visit 3 (up to 3 months later)
Title
Number of Subjects With Positive FBB PET Scan
Description
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.
Time Frame
Visit 3 (up to 6 months after baseline evaluation)
Title
Number of Subjects With Negative FBB PET Scans
Description
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.
Time Frame
Visit 3 (up to 6 months after baseline evaluation)
Title
Number of Subjects With Contraindicated or Failed Lumbar Puncture
Description
Number of subjects with contraindicated or failed LP (anticoagulant therapy, thrombocytopenia, lumbar puncture failed, spinal problems)
Time Frame
Visit 1 (baseline evaluation)
Title
Number of Subjects With Available CSF Analysis But Results Considered as Non-contributory by the Clinician
Description
Non-contributory CSF results (ambiguous CSF result, CSF result inconsistent with clinical information, uninterpretable CSF result for technical reasons)
Time Frame
Visit 1 (baseline evaluation)
Title
Number of Subjects Who Refused Lumbar Puncture.
Time Frame
Visit 1 (baseline evaluation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu Ceccaldi, Prof. MD.
Organizational Affiliation
Hôpital de La Timone, Marseille, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Guedj, Prof.
Organizational Affiliation
Hôpital de la Timone, Marseille, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coordinating center (Hôpital de La Timone) and 18 associated centers in France
City
Marseille
ZIP/Postal Code
13385
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29107051
Citation
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.
Results Reference
derived

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

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