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 | 17.0 |
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 establish the efficacy of Lu AE58054 as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer?s disease (AD) |
Determinar la eficacia de Lu AE58054 como tratamiento complementario a los inhibidores de la acetilcolinesterasa (IACE) para el tratamiento sintomático de los pacientes con enfermedad de Alzheimer (EA) leve o moderada |
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E.2.2 | Secondary objectives of the trial |
? To investigate the effect of Lu AE58054 as adjunctive therapy to AChEIs on neuropsychiatric symptoms in patients with mild-moderate AD ? To evaluate the safety and tolerability of Lu AE58054 as adjunctive therapy to AChEIs in patients with mild-moderate AD |
Investigar el efecto de Lu AE58054 como tratamiento complementario de los IACE en los síntomas neuropsiquiátricos en pacientes con EA leve o moderada Evaluar la seguridad y la tolerabilidad de Lu AE58054 como tratamiento complementario de los IACE en pacientes con EA leve o moderada |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? The patient has a knowledgeable and reliable caregiver. ? The patient is an outpatient. ? The patient has probable AD. ? The patient has mild to moderate AD. ? Stable treatment with an AChEI. ? The patient, if a woman, must have had her last natural menstruation ?24 months prior to baseline, OR be surgically sterile. ? The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit. |
?El paciente tiene un cuidador competente y fiable ?El sujeto es un paciente ambulatorio ?El paciente está diagnosticado de EA probable ?El paciente tiene enfermedad de Alzheimer leve o moderada ?El paciente tiene un tratamiento estable con un IACE ?Si es mujer, la paciente deberá haber tenido su última menstruación natural ?24 meses antes de la visita de selección, O haberse sometido a esterilización quirúrgica antes de la visita de selección. ?El paciente, si es varon, deberá utilizar métodos anticonceptivos efectivos según se define en el protocolo si su pareja femenina está en edad fértil; O haberse sometido a esterilización quirúrgica antes de la visita de selección. |
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E.4 | Principal exclusion criteria |
? The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD. ? The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD. ? The patient has evidence of clinically significant disease. ? The patient's current AChEI therapy is likely to be interrupted or discontinued during the study. ? The patient is currently receiving memantine or has taken memantine within 2 months prior to screening. |
?El paciente tiene signos de enfermedad neurodegenerativa de importancia clínica u otros trastornos neurológicos graves distintos de la EA incluidas. ?El paciente sufre cualquier trastorno psiquiátrico o trastorno del eje I (Manual diagnóstico y estadístico de los trastornos mentales, 4ª edición, texto revisado (DSM-IV-TR ?)) distinto de la EA. ?El paciente presenta signos de una enfermedad de importancia clínica. ?Es probable que haya que interrumpir o suspender el tratamiento con IACE del paciente durante el estudio. ?El paciente está recibiendo memantina o la ha tomado en los 2 meses previos a la visita de selección |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in cognition: Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score |
Cambio cognitivo: Cambio en la evaluación de la enfermedad de la subescala de la Escala-cognitivo del Alzheimer (ADAS-cog) puntuación total |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline and Week 24 |
Momento basal y semana 24 |
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E.5.2 | Secondary end point(s) |
? Change in global impression: Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score ? Change in functioning: Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score ? Change in behavioural disturbance: Change in Neuropsychiatric Inventory (NPI) total score ? Change in individual behavioural disturbance items: Change in single NPI item scores ? Change in anxiety: Change in NPI Anxiety item score based on a pre-specified NPI Anxiety score at Baseline ? Clinical response: Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes ? Clinical worsening: Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes ? Change in cognitive aspects of mental function: Change in Mini Mental State Examination (MMSE) ? Change in health-related quality of life (EQ-5D): Change in EuroQol 5-dimensional (EQ-5D) utility score ? Change in health-related quality of (EQ-5D VAS): Change in EQ-5D Visual Analogue Scale (EQ-5D VAS) ? Number of patients with adverse events (AEs): Overview of AEs ? Proportion of patients who withdrew due to intolerance to treatment ? Risk of suicidality: Columbia Suicide Severity Rating Scale (C-SSRS) |
?Impresión clínica global del cambio del Alzheimer?s Disease Cooperative Study (ADCS-CGIC). ?Cambio del Inventario de actividades de la vida diaria del Alzheimer?s Disease Cooperative Study (ADCS-ADL23). ?Cambio en el trastorno de la conducta: Cambio de la puntuación total del NPI ?Cambio en elementos individuales de perturbación conductual:Cambio de la puntuación de los apartados individuales del NPI ?Cambio en ansiedad: Cambio de la puntuación del apartado de ansiedad del NPI basado en una puntuación de Ansiedad NPI pre-definidos en el momento basal ?Respuesta clínica: Basado en cambios pre-definidos en la ADAS-Cog, en el ADCS-ADL23 y la ADCS-CGIC. ?Empeoramiento clinico: Basado en cambios pre-definidos en la ADAS-Cog, en el ADCS-ADL23 y la ADCS-CGIC. ?Cambios en aspectos cognitivos de la función mental: Cambio Miniexamen del estado mental (MMSE) ?Cambio en una medida de la calidad de vida relacionada con la salud (EQ-5D): Cambio de la puntuación de utilidad del EQ-5D. ?Cambio en una medida de la calidad de vida relacionada con la salud (EQ-5D): Cambio de la EAV del EQ-5D. ?Numero de pacientes con efectos adverso (EAs): Información general de EA ?Proporcion de pacintes que descontinúan debido a intolerancia del tratamiento ?Riesgo de suicidio: Escala de evaluación de la intensidad del riesgo de suicidio de Columbia (C-SSRS) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline and Week 24 |
Momento basal y semana 24 |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 |
Brazil |
Czech Republic |
Germany |
Israel |
Japan |
Korea, Republic of |
Mexico |
Netherlands |
Serbia |
Singapore |
Slovakia |
Spain |
Switzerland |
Turkey |
United Kingdom |
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
|
LVLS |
Ultima visita ultimo paciente |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |