E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced dementia |
Demencia avanzada |
|
E.1.1.1 | Medical condition in easily understood language |
Advanced dementia |
Demencia avanzada |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
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 effect of maintaining drug therapy for dementia (IACh and / or memantine) versus withdrawal in patients with advanced dementia in terms of time to institutionalization and / or progression of disability, defined as loss of 2 of 4 basic functions, or 6 of 11 instrumental functions, according to the activities of the BADLS scale at 12 months. |
Evaluar el efecto de mantener el tratamiento con fármacos para la demencia (IACh y/o memantina) frente a su retirada en pacientes con demencia avanzada en términos de tiempo hasta institucionalización y/o progresión de la incapacidad, definidos como pérdida de 2 de 4 funciones básicas, o de 6 de 11 funciones instrumentales, según las actividades de la escala BADLS a los 12 meses. |
|
E.2.2 | Secondary objectives of the trial |
To assess the effect of maintaining drug therapy for dementia (IACh and / or memantine) versus withdrawal in patients with advanced dementia in terms of changes in functional status, cognitive status, patient quality of life, and caregiver burden and cost-effectiveness of the intervention |
Evaluar el efecto de mantener el tratamiento con fármacos para la demencia (IACh y/o memantina) frente a su retirada en pacientes con demencia avanzada en términos de cambios en el estado funcional, cognitivo, calidad de vida de paciente y sobrecarga del cuidador e coste-efectividad de la intervención |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with severe Alzheimer's disease, with or without a coexisting diagnosis of vascular dementia - Score of ≤10 on the Standardized Mini-Mental State - Previously treatred with ChI (with or without memantine) for at least 3 months |
- Paciente con EA, DV (subcortical de pequeño vaso) o mixta, confirmado por su neurólogo o médico de familia. -Demencia avanzada (MMSE ≤ 10) - Tratamiento con fármacos para la demencia (IACh y/o memantina) al menos los 3 meses previos |
|
E.4 | Principal exclusion criteria |
- Patients with another type of advanced dementia. - Life expectancy less than 1 year |
- Pacientes con otro tipo de demencia avanzada - Pacientes con una esperanza de vida inferior al seguimiento del estudio; |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time to nursing home placement or progression of disabiliy, defined by loss of either two of four basic, or six of 11 instrumental, activities on the Bristol activities of daily living scale (BADLS) at 12 months |
Tiempo hasta institucionalización y/o progresión de la incapacidad, definidos como pérdida de 2 de 4 funciones básicas, o de 6 de 11 funciones instrumentales, según la Bristol Activities of Daily Living Scale (BADLS) a los 12 meses |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1,3,6 and 12 months |
1,3,6 y 12 meses |
|
E.5.2 | Secondary end point(s) |
- Functional status assesed as changes in the BADLS and FAST scale at 1,3,6 and 12 months - Cognitive status assesed as changes in the MMSE and SIB-s scale at 1,3,6 and 12 months. - Quality of life assesed as changes in the QUALID scale at 1,3,6 and 12 months and the EuroQol at 12 months. - Changes on the NPI-Q at 1,3,6 and 12 months. - Changes in the Clinical Global Impressions Scale at 12 months. - Caregiver burden: changes in the Zarit scale at 12 months. - Resource Utilization in Dementia and cost-effectiviness of the intervention |
- Estado funcional valorada con la escala BADLS y FAST basal a 1,3,6 y 12 meses. - Estado cognitivo del paciente valorado en la escala SIB-abreviada y SMMSE basal a 1,3,6 y 12 meses. - Calidad de vida de valorada en la escala QUALID 1,3,6 y 12 meses y EuroQol basal y 12 meses. - SCPD valorada en la escala NPI-Q basal a 1,3,6 y 12 meses. - Impresión Clínica Global de cambio valorada con la escala CGIC a fin de estudio. - Sobrecarga del cuidador de la escala Zarit basal a fin de estudio. - Utilización de recursos sanitarios (RUD Lite) y coste-efectividad en términos de costes por AVAC a fin de estudio. - Seguridad en términos de mortalidad y perfil de AA a fin de estudio. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1,3,6 and 12 months |
1,3,6 y 12 meses |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 |
Retirada del fármaco anti-demencia |
Anti-dementia drug withdrawal |
|
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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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 DE ESTUDIO |
|
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 | |
E.8.9.1 | In the Member State concerned days | |