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

NCT ID: NCT02681172

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-11-30

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.

Conditions

Alzheimer's Disease (AD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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%.

Group Type: EXPERIMENTAL

Neuraceq (florbetaben 18F)

Intervention Type: 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.

PET

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DRUG

PET

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

Intervention Type: PROCEDURE

Other Intervention Names

FBB; Positron Emission Tomography

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Piramal Imaging Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathieu Ceccaldi, Prof. MD.

Role: PRINCIPAL_INVESTIGATOR

Hôpital de La Timone, Marseille, France

Eric Guedj, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hôpital de la Timone, Marseille, France

Locations

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

Marseille, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 29107051 (View on PubMed)

Other Identifiers

2015-002606-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FBB_01_02_2015

Identifier Type: -

Identifier Source: org_study_id