E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
mild cognitive impairment, Alzheimer disease,frontotemporal dementia, SLA |
declino cognitivo lieve, malattia di Alzheimer, demenza frontotemporale, sclerosi laterale amiotrofica |
|
E.1.1.1 | Medical condition in easily understood language |
cognitive and motor impairment |
disturbi cognitivi e motori |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050727 |
E.1.2 | Term | RI scan |
E.1.2 | System Organ Class | 100000004848 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to use the radiotracer [11C] PK-PET imaging as early biomarker applicable in the clinical field, with the PET methodology, in neurodegenerative diseases |
utilizzare il radiotracciante [11C]PK-PET imaging come biomarcatore precoce applicabile in campo clinico, con la metodica PET, nelle patologie neurodegenerative. |
|
E.2.2 | Secondary objectives of the trial |
(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. |
(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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
pazienti affetti da malattie neurodegenerative (declino cognitivo lieve, malattia di Alzheimer, demenza frontotemporale, sclerosi laterale amiotrofica) su base sporadica o genetica; pazienti maschi e femmine di eta' superiore ai 18 anni |
|
E.4 | Principal exclusion criteria |
focal brain , physical, psychiatric or metabolic disorders which might otherwise explain the cognitive and / or motor impairment. |
patologie cerebrali focali, fisiche, psichiatriche o metaboliche che possano altrimenti spiegare i disturbi cognitivi e/o motori. |
|
E.5 End points |
E.5.1 | 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 |
utilizzare il radiotracciante [11C]PK-PET imaging come biomarcatore precoce applicabile in campo clinico, con la metodica PET, nelle patologie neurodegenerative. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
at the end of the study |
al termine dello studio |
|
E.5.2 | 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 |
(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 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
at the end of the study |
al termine dello studio |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |