E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
memory complaint, mild cognitive impairment, Alzheimer's Disease in predrmentia/prodromal disease phases |
disturbo di memoria, declino cognitivo lieve, malattia di Alzheimer in fase prodromica/predemenza e di demenza |
|
E.1.1.1 | Medical condition in easily understood language |
cognitive disorders |
disturbi cognitivi |
|
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 | 22.1 |
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 study the diagnostic accuracy of semiquantitative single-subject analysis of [18F]Florbetaben PET imaging as early marker of Alzheimer’s disease in subjects with memory complaint |
valutare l’accuratezza diagnostica della metodica PET con tracciante per l’amiloide ([18F]Florbetaben) analizzata a livello del singolo soggetto e con metodi semi-quantitativi come marcatore precoce di malattia di Alzheimer in soggetti affetti da disturbo cognitivo di memoria |
|
E.2.2 | Secondary objectives of the trial |
to correlate the amyloid burden with neuropsychological and clinical measures, as well as with CSF Aß42 and Tau levels, MRI e [18F]FDG-PET data (acquired before the enrolment in the present study) |
correlare il carico amiloideo con le misure neuropsicologiche, gli indici clinici, i valori di Aß42, Tau totale e fosfo-Tau e con i dati di RM e [18F]FDG-PET precedentemente acquisiti per scopi diagnostici |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
diagnosis of memory complaint, mild cognitive impairment or Alzheimer disease; age > 18 years old |
diagnosi di disturbo soggettivo di memoria, declino cognitivo lieve o malattia di Alzheimer in fase lieve; età > 18 anni |
|
E.4 | Principal exclusion criteria |
presence of other neurological and clinical condition responsible of cognitive disorders; liver and kidney failure; pregnancy and breastfeeding; fertile women do not using contraceptive drugs; hypersensitivity to active principle and excipients (ascorbic acid; anidre ethanol; macrogol 400; ascorbic sodium; water for injections) |
evidenza di patologie cerebrali focali, fisiche, psichiatriche o metaboliche che possano altrimenti spiegare i disturbi cognitivi; pazienti con insufficienza epatica o renale; donne in gravidanza o in allattamento; donne fertili che non fanno uso di contraccettivi, ipersensibilità al principio attivo o a uno qualsiasi dei seguenti eccipienti: acido ascorbico, etanolo anidro, macrogol 400, sodio ascorbato, acqua per preparazioni iniettabili |
|
E.5 End points |
E.5.1 | Primary end point(s) |
to define the role of amyloid burden quantification in the early diagnosis of Alzheimer disease |
definire il valore del carico di proteina amiloide studiato con PET con tracciante [18F]Florbetaben in soggetti con malattia di Alzheimer in fase prodromica/predemenza |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
at the end of the study |
alla fine dello studio |
|
E.5.2 | Secondary end point(s) |
to evaluate the relationship between the amyloid burden with neuropsychological and clinical measures, as well as with CSF Aß42 and Tau levels, MRI and [18F]FDG-PET data (acquired before the enrollment in the present study) |
correlare il carico amiloideo con le misure neuropsicologiche, gli indici clinici, i valori di Aß42, Tau totale e fosfo-Tau e con i dati di RM e [18F]FDG-PET precedentemente acquisiti per scopi diagnostici |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
at the end of the study |
alla fine 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 | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |