E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild Congitive Impairment (MCI) |
Deterioramento cognitivo lieve |
|
E.1.1.1 | Medical condition in easily understood language |
cognitive disturbances |
LIEVI DISTURBI DI MEMORIA |
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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 | 10022891 - Investigations |
|
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 |
The main study objective is to expand the investigation of diagnostic and monitoring basic markers (structural MRI, tau/abeta42 levels in the CSF, FDG PET) to advanced marker, such as molecular imaging. We will use the [11C]PK11195 (pk) that represents a validated and specific PET radioligand marker of activated microglia. Other advanced techniques will allow to collect advanced markers: Diffusion Tensor Imaging Sequences; resting functional magnetic resonance and protein p53 |
Espandere la ricerca (diagnostica e di monitoraggio) di marcatore avanzato dell'Alzheimer mediante l’Imaging molecolare. Verrà utilizzato il radio traccinate ((R)-[N-metil-11C]-PK11195) applicato alla metodica PET |
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E.2.2 | Secondary objectives of the trial |
•To set up a large dataset of MCI patients providing clinical, imaging, and biological data (basic markers) collected at baseline in a standardized and centralized fashion, including clinical data relative to disease progression after a 12-month follow-up. •To identify the combination of basic markers with the highest accuracy for diagnosing of AD at the MCI stage. •To identify which combination of basic markers is more sensitive to disease progression. •To evaluate the incidence of Adverse events reported during all the study and until 7 days after PK administration as reported by phone. •To evaluate the vital signs at baseline (before and after radiotracer administration) and at 12-month follow-up visit |
-raccogliere una serie di marcatori di base clinici, di imaging, ematici di pazienti con MCI in maniera standardizzata e centralizzata. Includendo dati relativi alla progressione della malattia osservati dopo 12 mesi (follow up) -identificare la combinazione di marcatori di base con la maggiore accuratezza per la diagnosi di AD allo stadio di MCI. -Identificare quale combinazione di marcatori di base è più sensibile alla progressione della malattia -Valutare l’incidenza di Eventi Avversi riportati durante lo studio e 7 giorni dopo, telefonicamente,la somministrazione di PK. -Valutare i segni vitali al basale (prima e dopo la somministrazione del radiotracciante) ed alla visita di follow-up (dopo 12 mesi) |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
OTHER SUBSTUDIES: Prot.Nr. 09/2011 Molecular Imaging. Vers 1.10.2011 - 15 pts with positivity of at least two basic markers (CSF and MR or CSF and FDG-PET)will undergo PET using PK
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ALTRI SOTTOSTUDI: Prot.No. 09/2011 Molecular Imaging Vers 01.10.2011- 15 pz con almeno due marcatori di base positivi (CSF e RM o CSF e PET con FDG) eseguiranno una PET con PK
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E.3 | Principal inclusion criteria |
-Male and female aged between 55-90 years; -Memory complains reflecting a change in cognition reported by patient or informant or clinician; -Presence of objective memory or other cognitive domain impairment; -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; -Mini-Mental State Exam score between 24 and 30 (inclusive); -Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5; -Amnestic Mild Cognitive Impairment (MCI) (pure amnestic or multidomain); -At least 5 grades education. -Written informed consent |
-Uomini e donne di età compresa tra i 55 e 90 anni -Lamentele riportate da parte dei pazienti, assistenti dei pazienti o medici per cambi della memoria cognitiva -Presenza di problemi obiettivi della memoria o nel campo cognitivo -Capacità cognitiva e motoria sufficientemente preservate tali non permettere la diagnosi di AD nel momento dell'inclusione -Punteggio tra 24 e 30 dell’esame Mini Mental State -Punteggio della Clinical Dementia Rating = 0.5 – il Box della memoria deve essere almeno 0.5 -Deterioramento cognitivo lieve amnestico (solo amnestico con diversi problemi) -Almeno 5 anni di studi scolastici - Consenso Informato Scritto |
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E.4 | Principal exclusion criteria |
-Visual and auditory acuity inadequate for neuropsychological testing; -History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrolment; -The chronic use of anti-inflammatory drugs -Female subjects of child-bearing potential with a positive pregnancy test; -Female subjects who are nursing; |
-Acuità visiva o auditiva inadeguata per eseguire i test neuropsicologici -Storia di problemi significativi a livello neurologico o psichiatrico o presenza di altre malattie che precludono l’arruolamento -Uso cronico di farmaci antinfiammatori -Donne in età fertile con test di gravidanza positivo -Donne in allattamento |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study objective is to expand the investigation of diagnostic and monitoring basic markers (structural MRI, tau/abeta42 levels in the CSF, FDG PET) to advanced marker, such as molecular imaging. We will use the [11C]PK11195 (pk) that represents a validated and specific PET radioligand marker of activated microglia. Other advanced techniques will allow to collect advanced markers: Diffusion Tensor Imaging Sequences; resting functional magnetic resonance and protein p53 |
Espandere la ricerca (diagnostica e di monitoraggio) di marcatore avanzato dell'Alzheimer mediante l’Imaging molecolare. Verrà utilizzato il radiottracciante ((R)-[N-metil-11C]-PK11195) applicato alla metodica PET |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
end of clinical trial |
Fine dello studio clinico |
|
E.5.2 | Secondary end point(s) |
•To set up a large dataset of MCI patients providing clinical, imaging, and biological data (basic markers) collected at baseline in a standardized and centralized fashion, including clinical data relative to disease progression after a 12-month follow-up. •To identify the combination of basic markers with the highest accuracy for diagnosing of AD at the MCI stage. •To identify which combination of basic markers is more sensitive to disease progression. •To evaluate the incidence of Adverse events reported during all the study and until 7 days after PK administration as reported by phone. •To evaluate the vital signs at baseline (before and after radiotracer administration) and at 12-month follow-up visit |
-raccogliere una serie di marcatori di base clinici, di imaging, ematici di pazienti con MCI in maniera standardizzata e centralizzata. Includendo dati relativi alla progressione della malattia osservati dopo 12 mesi (follow up) -identificare la combinazione di marcatori di base con la maggiore accuratezza per la diagnosi di AD allo stadio di MCI. -Identificare quale combinazione di marcatori di base è più sensibile alla progressione della malattia -Valutare l’incidenza di Eventi Avversi riportati durante lo studio e 7 giorni dopo, telefonicamente,la somministrazione di e PK. -Valutare i segni vitali al basale (prima e dopo somministrazione del radiotracciante) e alla visita di follow-up (dopo 12 mesi) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
end of clinical trial |
fine dello studio clinico |
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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 | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | 0 |