Phase 4
N=218
Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD
Alzheimer's Disease (AD)
Bottom Line
View on ClinicalTrials.gov: NCT02681172 ↗Enrolled (actual)
218
Serious AEs
0.5%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes — 137 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Neuraceq (florbetaben 18F) (Drug); PET (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Piramal Imaging Limited
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes |
137 | — |
| SECONDARY Number of Subjects With Improved Level of Physician Confidence in Diagnosis at Visit 3 |
167 | — |
| SECONDARY Number of Participants With a Change of Management Plan Comparing Pre- and Post-scan Outcomes |
164 | — |
| SECONDARY Number of Subjects With Positive FBB PET Scan |
132 | — |
| SECONDARY Number of Subjects With Negative FBB PET Scans |
73 | — |
| SECONDARY Number of Subjects With Contraindicated or Failed Lumbar Puncture |
45 | — |
| SECONDARY Number of Subjects With Available CSF Analysis But Results Considered as Non-contributory by the Clinician |
87 | — |
| SECONDARY Number of Subjects Who Refused Lumbar Puncture. |
75 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT02681172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.