Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease (ALPO)
1 de abril de 2021 actualizado por: Orion Corporation, Orion Pharma
Safety and Efficacy of ORM-12741 on Cognitive and Behavioral Symptoms in Patients With Alzheimer's Disease
The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of cognitive and behavioral symptoms in patients with Alzheimer's disease.
Tipo de estudio
Intervencionista
Inscripción (Actual)
100
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Turku, Finlandia, 20520
- Clinical Research Services Turku (CRST)
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
55 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Informed consent obtained from the patient and legally acceptable representative, if required
- Informed consent obtained from the caregiver
- Males and and females between 55-90 years
- Diagnosis of probable Alzheimer's disease, history of progressive cognitive deterioration
- Brain imaging consistent with Alzheimer's disease
- Mini-mental state examination score 12-21
- Treated with donepezil, rivastigmine or galantamine
- At least mild level of behavioral symptoms
Exclusion Criteria:
- Other types of dementias
- Modified Hachinski Ischemia Score > 4
- Use of memantine, antipsychotics, anticholinergic medication and benzodiazepines (at a max of 3 nights/week) within 2 months
- Changes in antidepressant dosing within 2 months
- Use of other psychotropic agents
- Myocardial infarction within the past 2 years
- Malignancy within the past 5 years
- Suicidal ideation, risk of suicide
- History of alcoholism or drug abuse within 5 years
- Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness
- Specific findings in brain imaging
- Abnormal findings in heart rate, blood pressure, ECG, laboratory tests, physical examination; orthostatic hypotension
- Blood donation or participation in a drug study within 60 days
- Previous AD immunotherapy treatment
- Patient cannot complete the computerised cognitive training
- Patients who reside in a skilled nursing facility
- Patients who are not able to swallow capsules
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo
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Placebo twice a day
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Experimental: Low dose of ORM-12741
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60mg twice a day
200mg twice a day
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Experimental: High dose of ORM-12741
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60mg twice a day
200mg twice a day
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Adverse Events
Periodo de tiempo: 3 months
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Adverse events from start of ORM-12741 treatment until end of study visit.
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3 months
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Quality of Episodic Memory
Periodo de tiempo: 3 months
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The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Quality of Episodic Memory measures the capability of maintaining information in episodic memory and is assessed as the sum of sensitivity indices from 4 memory tasks on the CDR computerised battery tests.
Values are calculated by a computer and higher scores mean better outcome.
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3 months
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Quality of Working Memory
Periodo de tiempo: 3 months
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The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Quality of Working Memory measures the capability of maintaining information in working memory and is assessed as the sum of sensitivity indices from 2 memory tasks on the CDR computerised battery tests.
Values are calculated by a computer and higher scores mean better outcome.
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3 months
|
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Quality of Memory
Periodo de tiempo: 3 months
|
The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Quality of Memory is a combination of outcome measures Quality of Working Memory & Quality of Episodic Memory.
Values are calculated by a computer and higher scores mean better outcome.
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3 months
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Speed of Memory
Periodo de tiempo: 3 months
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The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Speed of Memory is assessed as the sum of speed measures from 2 memory tasks and 2 recognition tasks on the CDR computerised battery tests.
Values are calculated by a computer and higher scores mean better outcome.
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3 months
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Power of Attention
Periodo de tiempo: 3 months
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The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Power of attention measures speed and attention and is assessed from 3 attentional tasks on the CDR computerised battery tests.
Values are calculated by a computer and higher scores mean better outcome.
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3 months
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Continuity of Attention
Periodo de tiempo: 3 months
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The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning.
Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerised battery tests.
Values are calculated by a computer and higher scores mean better outcome.
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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NPI Total Score
Periodo de tiempo: 3 months
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The total score of Neuropsychiatric Inventory (NPI) was assessed by a caregiver interview.
10 behavioral areas were included: Delusions, Hallucinations, Agitation/Aggression, Depression/Dysphoria, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability/Lability, and Aberrant Motor Behaviour.
Higher scores mean worse outcome.
Minimum value 0, maximum value 120.
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3 months
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Caregiver Distress Score
Periodo de tiempo: 3 months
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Caregiver distress score generated by adding together the scores of individual NPI distress questions of Neuropsychiatric Inventory NPI.
Higher scores mean worse outcome.
Minimum value 0, maximum value 120.
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3 months
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Pharmacokinetics of ORM-12741
Periodo de tiempo: 3 months
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ORM-12741 plasma trough concentrations at week 12.
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3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Juha Rinne, Prof, Clinical Research Services Turku (CRST)
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de abril de 2011
Finalización primaria (Actual)
1 de septiembre de 2012
Finalización del estudio (Actual)
1 de octubre de 2012
Fechas de registro del estudio
Enviado por primera vez
24 de marzo de 2011
Primero enviado que cumplió con los criterios de control de calidad
25 de marzo de 2011
Publicado por primera vez (Estimar)
29 de marzo de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
1 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 3098006
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .