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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Piramal Imaging Limited

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