E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alzheimer's Disease |
Enfermedad de Alzheimer |
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E.1.1.1 | Medical condition in easily understood language |
Alzheimer's Disease |
Enfermedad de 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). |
Evaluar la seguridad y la tolerabilidad a largo plazo de ABBV-8E12 en sujetos con enfermedad de Alzheimer temprana (EA). |
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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 disease-related and drug-related biomarkers in subjects with early AD (exploratory objective) |
Evaluar la farmacocinética (FC) de ABBV-8E12 en sujetos con EA temprana. Evaluar la eficacia a largo plazo de ABBV-8E12 para frenar la progresión de la enfermedad en sujetos con EA temprana (objetivo exploratorio). Evaluar el efecto a largo plazo de ABBV-8E12 en un rango de biomarcadores relacionados con la enfermedad y relacionados con los fármacos en sujetos con EA temprana (objetivo exploratorio). |
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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. |
• El sujeto ha proporcionado voluntariamente consentimiento informado por escrito. • El sujeto completó el período de tratamiento de 96 semanas del estudio M15-566. • El sujeto tiene un acompañante identificado y de confianza, que tiene contacto frecuente con el sujeto y que proporcionará información sobre las capacidades cognitivas y funcionales del sujeto. • El acompañante del estudio ha proporcionado consentimiento informado por escrito. • Si es mujer, debe ser posmenopáusica o estar sometida a esterilización quirúrgica permanente (ooforectomía bilateral, salpingectomía bilateral o histerectomía). • Si es varón sexualmente activo con pareja(s) femenina(s) en edad fértil, debe comprometerse a utilizar los métodos anticonceptivos especificados en el protocolo desde el Día 1 del estudio hasta 20 semanas después de recibir la última dosis del fármaco del estudio y debe abstenerse de donar esperma. |
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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. |
• El sujeto presenta un cambio significativo en su estado médico desde su participación en el estudio M15-566 que podría interferir con su participación en el estudio M15-570, podría suponer un mayor riesgo para el sujeto o confundir la interpretación de los resultados del estudio. Esto incluiría cualquier trastorno neurológico, hematológico, autoinmune, endocrino, cardiovascular, neoplásico, renal, hepático, metabólico, psiquiátrico, pulmonar, gastrointestinal u otro trastorno clínicamente significativo o contraindicación o incapacidad para tolerar las RM cerebrales o los PET. • Han transcurrido más de 8 semanas desde que el sujeto recibió su última dosis del fármaco del estudio M15-566. • El sujeto está participando simultáneamente en otro estudio clínico intervencionista (a excepción del estudio M15-566) con un fármaco. • El investigador considera que el sujeto no es un candidato adecuado para recibir ABBV-8E12 o que el sujeto es incapaz o es poco probable que cumpla con la pauta de administración o las evaluaciones del estudio. |
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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 |
Acontecimientos adversos, constantes vitales, examen físico, examen neurológico, electrocardiograma (ECG), pruebas de laboratorio, escala de valoración del riesgo de suicidio de la Universidad de Columbia (C-SSRS), RM y evaluaciones de inmunogenicidad. |
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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) |
Farmacocinética (aclaramiento y volumen de distribución). |
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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 | Yes |
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 | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
alternative dose of ABBV-8E12 |
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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 | 4 |
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 | No |
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 |