E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alzheimer's Disease |
Malattia di Alzheimer |
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E.1.1.1 | Medical condition in easily understood language |
Alzheimer's Disease |
Malattia di Alzheimer |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001896 |
E.1.2 | Term | Alzheimer's disease |
E.1.2 | System Organ Class | 100000004852 |
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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 assess the long-term safety and tolerability of ABBV-8E12 in subjects with early Alzheimer's disease (AD). |
Valutare la sicurezza e la tollerabilità a lungo termine di ABBV-8E12 in soggetti affetti da malattia di Alzheimer (AD) in fase precoce. |
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E.2.2 | Secondary objectives of the trial |
To assess the pharmacokinetics (PK) of ABBV-8E12 in subjects with early AD To assess the long-term efficacy of ABBV-8E12 in slowing disease progression in subjects with early AD (exploratory objective) To assess the long-term effect of ABBV-8E12 on a range of diseaserelated and drug-related biomarkers in subjects with early AD (exploratory objective) |
Valutare il profilo di farmacocinetica (PK) di ABBV-8E12 in soggetti affetti da malattia di Alzheimer in fase precoce. Valutare l’efficacia a lungo termine di ABBV-8E12 nel rallentare la progressione della malattia in soggetti affetti da AD in fase precoce (endpoint esplorativo). Valutare nel lungo termine gli effetti di ABBV-8E12 su una serie di biomarcatori correlati alla malattia e correlati al medicinale in soggetti affetti da AD in fase precoce(endpoint esplorativo). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject has voluntarily provided written informed consent Subject completed the 96-week treatment period of Study M15-566. Subject has an identified, reliable study partner who has frequent contact with the subject and who will provide information as to the subject's cognitive and functional abilities. The study partner has provided written informed consent. If female, subject must be postmenopausal or permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). If the male subject is sexually active with female partner(s) of childbearing potential, he must agree, from Study Day 1 through 20 weeks after the last dose of study drug to practice the protocol specified contraception and must refrain from sperm donation. |
Soggetto che ha volontariamente firmato il modulo di consenso informato scritto Soggetto che ha completato il periodo di trattamento della durata di 96 settimane nell’ambito dello studio M15-566. Soggetto per cui è disponibile la presenza di un partner identificato e affidabile per lo studio che abbia frequenti contatti con il soggetto e che fornirà informazioni relative alle capacità cognitive e funzionali del soggetto. Il partner per lo studio ha firmato il modulo di consenso informato scritto I soggetti di sesso femminile devono essere in stato di postmenopausa oppure chirurgicamente sterili in maniera permanente (ovariectomia bilaterale, salpingectomia bilaterale o isterectomia). I soggetti di sesso maschile sessualmente attivi con partner femminile/i in età fertile, dovranno acconsentire a fare uso del metodo contraccettivo specificato nel protocollo e astenersi dalla donazione di sperma. a partire dal Giorno 1 dello studio e fino a 20 settimane dopo l’ultima dose del medicinale sperimentale. |
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E.4 | Principal exclusion criteria |
Subject has any significant change in his/her medical condition since participation in Study M15-566 that could interfere with the subject's participation in Study M15-570, could place the subject at increased risk, or could confound interpretation of study results. This would include any clinically significant neurological, hematological, autoimmune, endocrine, cardiovascular, neoplastic, renal, hepatic, metabolic, psychiatric, pulmonary, gastrointestinal, or other major disorder or contraindication to or inability to tolerate brain MRI or PET scans.
More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-566.
Subject is concurrently enrolled in another interventional clinical study (with the exception of Study M15-566) involving a therapeutic agent.
Subject is considered by the investigator to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations. |
Soggetto che presenta qualsiasi cambiamento significativo delle proprie condizioni cliniche dal momento della fine della propria partecipazione allo studio M15-566, che potrebbe interferire con la partecipazione del soggetto allo studio M15-570,esporlo a un rischio aumentato o potenzialmente rappresentare un fattore confondente nel l’interpretazione dei risultati dello studio. Fra tali cambiamenti sono incluse qualsiasi condizione clinicamente significativa di natura neurologica, ematologica, autoimmune, endocrinologica, cardiovascolare, neoplastica, renale, epatica, metabolica, psichiatrica, polmonare, gastrointestinale o altro disturbo rilevante oppure la controindicazione o impossibilità a tollerare l’esecuzione di una risonanza magnetica (RM) cerebrale oppure scansione PET
Devono essere trascorse oltre 8 settimane dal momento in cui il soggetto ha ricevuto l’ultima dose di medicinale sperimentale nell’ambito dello studio M15-566.
Soggetto che sia attualmente arruolato in un altro studio clinico interventistico (ad eccezione dello studio M15-566) che prevede l’uso di un agente terapeutico
Soggetto che lo sperimentatore considera non essere idoneo a ricevere ABBV-8E12, oppure soggetto che lo sperimentatore consideri non in grado o probabilmente non in grado di aderire al regime posologico o a sottoporsi alle valutazioni previste dallo studio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Adverse events, vital signs, physical examination, neurologic examination, electrocardiogram (ECG), laboratory tests, Columbian Suicide Severity Rating Scale (C-SSRS), MRI, and immunogenicity assessments |
Eventi avversi, segni vitali, esame obiettivo, esame neurologico, elettrocardiogramma (ECG), analisi di laboratorio, punteggio della scala Columbia di gravità del rischio di suicidio (C-SSRS), RM e valutazioni di immunogenicità. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Pharamokinetics (Clearance and Volume of Distribution) |
Farmacocinetica (Clearance e volume di distribuzione) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
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 | 2 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
New Zealand |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 8 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 27 |
E.8.9.2 | In all countries concerned by the trial years | 8 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 27 |