Mild Cognitive Impairment MedDRA version: 18.0 Level: LLT Classification code 10050727 Term: RI scan System Organ Class: 100000004848
Conditions
Interventions
Trade Name: NEURACEQ - 300 MBQ/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO MONODOSE
Product Name: Florbetaben
Product Code: BAY 94-9172
Pharmaceutical Form: Solutio
Sponsors
HôPITAUX UNIVERSITAIRES DE GENèVE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written Inform Consent to participating; 2. Subjects must be included in an ADNI compatible study including neuropsychological assessment, Magnetic Resonance (MR) at 1.5T or 3T, CSF collection and Abeta42 and tau assay. Neuropsychological assessment should include: Mini Mental State Examination (MMSE), Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog), Rey Auditory Verbal Learning Test (AVLT), Logical Memory Test (immediate and delayed recall), Controlled Oral Word Association Test (COWAT), Category fluency, Boston Naming Test (BNT), Trail Making Test (TMT), Digit Symbol Substitution Test, Clock Drawing Test, Digit Span Forward and Digit Span Backward. 3. Age between 55 and 90 years; 4. Diagnosis of MCI (pure amnestic or multidomain); 5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer’s disease cannot be made by the site physician at the time of the screening visit; 6. Mini Mental State Examination score between 24 and 30 (inclusive); 7. Abnormal memory function documented by scoring 1 SD below the age-adjusted mean on the Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scale-R; 8. Clinical Dementia Rating – Sum of Boxes (CDR-SB) = 0.5. Memory Box score must be at least 0.5; 9. Geriatric Depression Scale (GDS) less than 6; 10. Modified Hachinski Ischemic Scale (MHIS) =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrolment; 2. Visual and auditory acuity inadequate for neuropsychological testing; 3. Enrollment in other trials or studies not compatible with FBB Imaging study; 4. Use of forbidden medication (see paragraph in the protocol); 5. Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture; 6. Women of childbearing potential who are not surgically sterile and not refraining from sexual activity. Women of childbearing potential must not be pregnant (negative urine ß-hCG at the time of screening and negative urine ß-hCGon the day of imaging) or breast feeding at screening. Women must avoid becoming pregnant in the 10 days prior to the PET scan and for 24 hours after administration of FBB Imaging. Men must avoid pregnancy with a female partner for 24 hours after administration of FBB Imaging; 7. Participation in any other PET ligand study within 4 weeks of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to evaluate the incremental diagnostic value for MCI due to Alzheimer Disease (AD) of Florbetaben (FBB) Imaging versus CSF markers (Ab42, t and ph-t) in patients with MCI.;Secondary Objective: //;Primary end point(s): The primary outcomes will be the differences of the change of physician’s diagnostic confidence (incremental confidence) between Rounds 1-2 and 2-3. Assuming that FBB imaging will be superior to CSF biomarker results, incremental confidence between Rounds 1-2 will represent the advantage of FBB imaging over CSF biomarker results between Clinical Raters, and incremental confidence between Rounds 2-3 will represent the advantage of FBB imaging over CSF biomarker results within Clinical Raters. Physician’s confidence will be validated versus adverse cognitive outcomes (development of dementia and cognitive deterioration) after 1 and 2 years;Timepoint(s) of evaluation of this end point: End of clinical trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes will be (i) the predictivity of cognitive outcomes by FBB imaging. The predictivity of hippocampal volumetry, CSF biomarkers, and FBB imaging towards cognitive outcomes at 1 and 2 years will be studied. The predictivity of FBB imaging will be contrasted to predictivity of the other biomarkers; and (ii) the agreement of the local reading by nuclear medics among themselves and with the centralized reading, and (iii) the agreement between local and centralized assays of CSF Ab42, whenever available;Timepoint(s) of evaluation of this end point: End of clinical tial | — |
Countries
France, Italy
Contacts
Public ContactDipartimento Scientifico
HôPITAUX UNIVERSITAIRES DE GENèVE
Outcome results
None listed