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