E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alzheimer?s disease |
Enfermedad de Alzheimer |
|
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 | 16.1 |
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 efficacy of Lu AE58054 as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-moderate Alzheimer?s disease |
Establecer la eficacia de Lu AE58054 como tratamiento adyuvante del donepezilo para el tratamiento sintomático de los pacientes con enfermedad de Alzheimer leve o moderada |
|
E.2.2 | Secondary objectives of the trial |
To investigate the effect of Lu AE58054 as adjunctive therapy to donepezil on neuropsychiatric symptoms in patients with mild-moderate Alzheimer?s disease |
Investigar el efecto de Lu AE58054 como tratamiento adyuvante del donepezilo sobre los síntomas neuropsiquiátricos en pacientes con enfermedad de Alzheimer leve o moderada |
|
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 donepezil. ? 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 informado y fiable. - El paciente es un paciente ambulatorio. - El paciente padece Enfermedad de Alzheimer EA probable. - El paciente padece EA leve o moderada. - Tratamiento estable con con donepezilo. - El paciente, si es una mujer, debe haber tenido su última menstruacción natural como mínimo?24 antes de la visita de selección O haber sido esterilizadas quirurgicamente. - El paciente, si es un hombre, está de acuerdo con utilizar los métodos anticonceptivos definidos en el protocolo si su pareja tiene capacidad de procrear O deben haber sido esterilizados quirurgicamente 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 donepezil 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 presenta signos de enfermedad neurodegenerativa clínicamente significativa y otros trastornos neurológicos graves distintos de la EA. - El paciente tiene un trastorno del eje I conforme al Manual diagnóstico y estadístico de los trastornos mentales, 4ª edición, texto revisado (DSM-IV-TR) distinto de la EA. - El paciente tiene signos de una enfermedad clínicamente significativa. -Es probable que se interrumpa o suspenda de forma definitiva el tratamiento con donepezilo del paciente durante el estudio. - El paciente está recibiendo memantina o ha utilizado memantina en los 2 meses previos a la visita de selección. |
|
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 en la función cognitiva: Cambio en la puntuación total de la subescala cognitiva de la escala de evaluación de la Enfermedad de Alzheimer (ADAS-cog). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline and Week 24 |
Momento Basal y Semana 24 |
|
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: Change in EuroQol 5-dimensional (EQ-5D) utility score ? Change in health-related quality of life: Change in EQ-5D Visual Analogue Scale (EQ-5D VAS) |
- Cambio en la impresión global: Puntuación de la Escala de Impresión Clínica Global de Cambio del Estudio Cooperativo de la Enfermedad de Alzheimer (ADCS-CGIC). - Cambio en función: Cambio en la puntuación total del Cuestionario sobre actividades de la vida diaria del Estudio Cooperativo de la Enfermedad de Alzheimer (ADCS-ADL23). -Cambio en trastornos del comportamiento; cambio en la puntuación total del Inventario neuropsiquiátrico (NPI). -Cambio en items individuales de trastorno del comportamiento; Cambio en la puntuación de ítems individuales del NPI. -Cambio en la ansiedad;cambio en la puntuación del ítem del Inventario neuropsiquiátrico (NPI) basados en una puntuación pre especificada del la ansiedad NPI en el momento basal -Respuesta clínica: Basada en cambios pre-especificados en ADAS-cog, ADCS-ADL23 y ADCS-CGIC. - Empeoramiento clínico: Pasado en cambios pre-especificados en ADAS-Cog, ADACS-ADL23 y ADCS-CGIC. - Cambio en aspectos cognitivos de la función mental: Cambio en el Miniexamen cognoscitvo (MMSE). - Cambio en la calidad de vida relacionada con la salud: Cambio en la puntuación de utilidad del cuestionario EuroQoL 5-dimensional (EQ-5D) -Cambio en la calidad de vida relacionada con la salud: Cambio en la Escala Analógica Visual (EQ-5D VAS) |
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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 |
|
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 | Yes |
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 | 3 |
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 | 59 |
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 |
Belgium |
Bulgaria |
Canada |
Denmark |
France |
Italy |
Sweden |
Argentina |
Chile |
Czech Republic |
Germany |
Spain |
Poland |
South Africa |
Ukraine |
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 |
Última visita del último paciente |
|
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 | 6 |
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 | 6 |