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Alzheimer's Disease (AD)Phase 4NCT02681172

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

A Phase 4 study testing Neuraceq (florbetaben 18F) and PET in people with Alzheimer's Disease (AD), run by Lantheus Biosciences Ltd. at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Alzheimer's Disease (AD)
What is being tested?
Neuraceq (florbetaben 18F) and PET
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
1 siteFrance
Study dates
Oct 2015to Nov 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Marseille, 13385

Other trials in France

About this study

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

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
Read the 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.

Being tested
Neuraceq (florbetaben 18F), PET
Keywords
CSF, Alzheimer's Disease (AD) and related dementia, HAS recommendations
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuraceq (florbetaben 18F)Drug

    Also called FBB

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

  • PETProcedure or surgery

    Also called Positron Emission Tomography

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

Study groups in NCT02681172
Study groupRoleWhat they receive
Neuraceq (florbetaben 18F) PET scanExperimentalA single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq will be administered per subject. The applied florbetaben radioactive dose will be ± 20%.
Receives: Drug: Neuraceq (florbetaben 18F); Procedure: PET

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)

Secondary outcomes (7)

  1. 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".

    Measured: Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)

  2. 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.

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

  3. 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.

    Measured: Visit 3 (up to 6 months after baseline evaluation)

  4. 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.

    Measured: Visit 3 (up to 6 months after baseline evaluation)

  5. 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)

    Measured: Visit 1 (baseline evaluation)

  6. 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)

    Measured: Visit 1 (baseline evaluation)

  7. Number of Subjects Who Refused Lumbar Puncture.

    Measured: Visit 1 (baseline evaluation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionSep 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02681172
Sponsor's protocol ID
FBB_01_02_2015
Other IDs
2015-002606-37, 2015
Status last verified
Mar 2018
First submitted
4 Feb 2016
Last updated
9 Oct 2026
Data monitoring committee
Yes
Individual data sharing
No

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 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.

    PubMed 29107051

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Neuraceq (florbetaben 18F) and PET in people with Alzheimer's Disease (AD), run by Lantheus Biosciences Ltd. at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02681172, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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