E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild Alzheimer's Disease |
Enfermedad de Alhzmeimer leve. |
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E.1.1.1 | Medical condition in easily understood language |
Mild Alzheimer's Disease |
Enfermedad de Alhzmeimer leve. |
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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 | 16.0 |
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 test the hypothesis that solanezumabwill slow the cognitive and functional decline of AD as compared with placebo in patients with mild AD. |
Probar la hipótesis de que solanezumab ralentizará el deterioro cognitivo y funcional asociado a la enfermedad de Alzheimer (EA) en comparación con el placebo, en pacientes con EA leve. |
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E.2.2 | Secondary objectives of the trial |
? To assess the relationship between treatment effect and time. ? To test the hypothesis that solanezumab will slow the rate of cognitive and functional decline associated with ADassessed using a slope analysis from a repeated-measures model. |
? Evaluar la relación entre el efecto del tratamiento y el tiempo. ? Probar la hipótesis de que solanezumab ralentizará la tasa de deterioro cognitivo y funcional asociada a la EA, en comparación con el placebo evaluada mediante un análisis de la pendiente del modelo para medidas repetidas. |
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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 |
H8A-MC-LZAX Addendum ? Lumbar Punctures Lumbar punctures will be used to collect cerebrospinal fluid (CSF) for assays of several CSF measures |
H8A-MC-LZAX(1) (punciones lumbares) Las punciones lumbares se utilizarán para extraer líquido cerebroespinal para evaluar diversas medidas del líquido crebroespinal. |
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E.3 | Principal inclusion criteria |
[1] Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer?s Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD. [2] Has a Modified Hachinski Ischemia Scale score of less than or equal to 4. [3] Has an MMSE score of 20 through 26 at Visit 1 (Screening visit). [4] Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form). [5] Has had an MRI or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD. [6] Male or female patients ages 55 to 90 years old. [7] Has a florbetapir PET scan or CSF result consistent with the presence of amyloid pathology at screening. |
[1] Cumplir los criterios de EA probable del National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer?s Disease and Related Disorders Association (NINCDS/ADRDA) (NINCDS/ADRDA). [2] Tener en la escala de isquemia de Hachinski modificada una puntuación menor o igual a 4. [3] Tener una puntuación de entre 20 y 26 en el MMSE en la visita 1 [4] Tener una puntuación menor o igual a 6 en la escala de depresión geriátrica [5] Haberse sometido a una RM o tomografía computerizada (TC) en los dos últimos años, en la que se haya confirmado la ausencia de hallazgos incompatibles con un diagnóstico de EA. [6] Varones o mujeres de edades comprendidas entre los 55 y los 90 años. [7] Tener un resultado en la PET con florbetapir o el análisis de LCR que indique la presencia de patología amiloide en la selección. |
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E.4 | Principal exclusion criteria |
[1] Does not have a reliable caregiver who is in frequent contact with the patient (defined as at least 10 hours per week), will accompany the patient to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications. [2] Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l?Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia. [3] Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator?s opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 years. [4] Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness. [5] Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment. [6] Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions [7] Has received AChEIs, memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments [8] Has received medications that affect the central nervous system (CNS), except treatments for AD for less than 4 weeks. |
[1] No disponer de un cuidador fiable que esté en contacto frecuente con el paciente (definido como, al menos, 10 horas a la semana), que acompañe al paciente a la consulta y/o esté disponible por teléfono a las horas designadas y que controle la administración de los medicamentos prescritos. [3] Cumplir los criterios de demencia vascular establecidos por el National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l?Enseignement en Neurosciences (NINDS/AIREN) (NINDS/AIREN) Presentar enfermedades graves o inestables, incluyendo enfermedades cardiovasculares (como cardiopatía isquémica inestable), hepáticas, renales, gastroenterológicas, respiratorias, endocrinas, neurológicas (además de EA), psiquiátricas, inmunológicas o hematológicas y otras afecciones que, en opinión del investigador, podrían interferir en los análisis de la seguridad y eficacia del presente estudio o supongan una esperanza de vida inferior a 2 años. [5] Tener un historial en los últimos 5 años de enfermedad maligna primaria o recurrente, con las excepciones de carcinoma de células escamosas cutáneo extirpado in situ, carcinoma basocelular, carcinoma de cuello uterino in situ o cáncer de próstata in situ con unos valores normales de antígeno prostático específico tras el tratamiento. [6] Tener un historial conocido de infección por el virus de la inmunodeficiencia humana (VIH), alergias a fármacos múltiples e intensas clínicamente significativas, reacciones de hipersensibilidad intensas postratamiento. [7] Haber recibido AChEI, memantina y/u otro tratamiento para la EA durante menos de 4 meses o llevar menos de 2 meses de terapia estable con estos tratamientos antes de la visita 2. [8] Haber recibido medicamentos que afectan al sistema nervioso central (SNC), salvo tratamientos para la EA durante menos de 4 semanas; es decir, las dosis de medicaciones crónicas que afectan al SNC deberán haberse mantenido estables al menos durante las 4 semanas anteriores a la visita 2. |
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E.5 End points |
E.5.1 | Primary end point(s) |
ADAS-Cog14 and ADCS-iADL |
ADAS-Cog14 y ADCS-iADL. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 0, 12, 28, 40, 52, 64, 80 and Early Discontinuation Visits |
Semana 0, 12, 28, 40, 52, 64, 80 y Visita de finalización temprana |
|
E.5.2 | Secondary end point(s) |
ADAS-Cog11, MMSE, ADCS-ADL, FAQ, CDR-SB, NPI, RUD-Lite, QoL-AD, and EQ-5D Proxy. |
ADAS-Cog11, MMSE, ADCS-ADL, FAQ, CDR-SB, NPI, RUD-Lite, QoL-AD y EQ-5D Proxy. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 0, 28, 52, 80 and Early Discontinuation Visits |
Semana 0, 28, 52, 80 y Visita de finalización temprana |
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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 | 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 | 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 | 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 | 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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 53 |
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 |
France |
Germany |
Italy |
Poland |
Spain |
Sweden |
United Kingdom |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |