mild cognitive impairment, Alzheimer's disease prodromal MedDRA version: 17.1 Level: LLT Classification code 10050727 Term: RI scan System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Neuraceq
Product Name: Neuraceq
Product Code: [18F]Florbetaben
Pharmaceutical Form: Solution for infusion
Sponsors
IRCCS Ospedale San Raffaele
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) memory disorder in long-term prevalent and persistent; b) the long history of the disease (> 2) without features of progression; c) [18F] FDG-PET imaging for positive selective mesial temporal hypometabolism in the absence of the typical AD pattern (bilateral temporo-parietal hypometabolism). The clinical and neuropsychological investigations, CSF, [18F] FDG-PET and MRI will be done outside of this protocol, as patients are routinely subjected to such investigations in clinical diagnostic path at the centers of sending, in case of clinical suspicion of neurodegenerative disease. Will be enrolled only patients aged> 18 years. All participants will be followed by a six-month clinical follow-up for at least 2 years in order to assess the possible clinical progression. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: focal brain disorders, physical, psychiatric or metabolic disorders that might otherwise explain the cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: define the value of the load of amyloid protein studied with PET tracer [18F] Florbetaben in subjects with mild cognitive impairment (MCI), amnestic type with long disease duration (range 2-10 years) and imaging studies (MRI and / or [18F] FDG-PET) suggestive of involvement of the limbic / mesial temporal.;Secondary Objective: correlate the amyloid load with neuropsychological measures, the clinical indices, the values of Aß42, total tau and phospho-tau and with data from MRI and [18F] FDG-PET previously acquired for diagnostic purposes.;Primary end point(s): define the value of the load of amyloid protein studied with PET tracer [18F] Florbetaben in subjects with mild cognitive impairment (MCI), amnestic type and subtype limbic;Timepoint(s) of evaluation of this end point: at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): correlate the amyloid load with neuropsychological measures, the clinical indices, the values of Aß42, total tau and phospho-tau and with data from MRI and [18F] FDG-PET previously acquired for diagnostic purposes;Timepoint(s) of evaluation of this end point: at the end of the study | — |
Countries
Italy
Contacts
Public ContactMedicina Nucleare
IRCCS Ospedale San Raffaele
Outcome results
None listed