mild cognitive impairment, Alzheimer disease,frontotemporal dementia, SLA MedDRA version: 14.1 Level: LLT Classification code 10050727 Term: RI scan System Organ Class: 100000004848
Conditions
Interventions
Product Name: NA
Product Code: (R)-[N-metil-11C1-PK11195(PK)
Pharmaceutical Form: Solution for injection
Current Sponsor code: (R)-[N-metil-11C]-PK11195
Concentration unit: MBq megabecquerel(s)
Concen
Sponsors
OSPEDALE S. RAFFAELE DI MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients with neurodegenerative diseases (mild cognitive impairment, Alzheimer's disease, frontotemporal dementia, amyotrophic lateral sclerosis SLA) on a sporadic or genetic base; male and female patients aged over 18 years. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: focal brain , physical, psychiatric or metabolic disorders which might otherwise explain the cognitive and / or motor impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to use the radiotracer [11C] PK-PET imaging as early biomarker applicable in the clinical field, with the PET methodology, in neurodegenerative diseases;Secondary Objective: (i) to identify novel mechanisms of regulation and function of microglia under various conditions (inflammatory stimuli; neurodegenerative and -regenerative model systems); (ii) to identify and implement new targets for activated microglia, which may serve for diagnostic (imaging) and therapeutic purposes; (iii) to design new molecular probes (tracers) for these novel targets and to implement and validate them in in vivo model systems and patients; (iv) to image and quantify modulated microglia activity in patients undergoing immune therapy for cognitive impairment and relate findings to clinical outcome.;Primary end point(s): to use the radiotracer [11C] PK-PET imaging as early biomarker applicable in the clinical field, with the PET methodology, in neurodegenerative diseases;Timepoint(s) of evaluation of this end point: at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): i) identificare nuovi meccanismi di regolazione e la funzione della microglia in varie condizioni (stimoli infiammatori, sistemi modello di tipo neurodegenerativo e rigenerativo); (ii) individuare ed implementare nuovi obiettivi per la microglia attivata, che possano essere utili per la diagnostica (imaging) e a fini terapeutici; (iii) progettare per questi obiettivi nuovi nuovi traccianti da validare in sistemi modello in vivo e nei pazienti; (iv) quantificare l'attività modulata della microglia in pazienti sottoposti a terapia immunitaria per peggioramento cognitivo e correlati di esito clinico;Timepoint(s) of evaluation of this end point: at the end of the study | — |
Countries
Italy
Contacts
Public ContactMedicina Nucleare
Ospedale San Raffaele
Outcome results
None listed