Resumen

Este estudio se realiza para determinar si el medicamento semaglutida tiene un efecto positivo sobre la enfermedad de Alzheimer temprana. Los participantes recibirán semaglutida o placebo (un medicamento «ficticio» que no contiene el medicamento del estudio); la asignación del tratamiento se decide mediante igual probabilidad. El estudio tendrá una duración de hasta 173 semanas (aproximadamente 3 años y 4 meses). Los participantes tendrán 17 visitas clínicas y 1 llamada telefónica con el médico del estudio. El estudio incluye diversas pruebas y exploraciones. En 10 de las visitas clínicas se extraerán muestras de sangre a los participantes. Los participantes deben contar con un compañero de estudio dispuesto a participar en el estudio. Las mujeres no pueden participar si están embarazadas, en período de lactancia o tienen previsto quedarse embarazadas durante el período del estudio. Se realizará un subestudio de líquido cefalorraquídeo (LCR) como parte del estudio. El subestudio se llevará a cabo en una selección de centros según su experiencia con la toma de muestras de LCR y su disposición a participar. Los criterios de valoración relacionados con este subestudio son únicamente exploratorios.

Elegibilidad

Edad mínima: 55 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.
MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria.
CDR (Clinical Dementia Rating) global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home \& hobbies, community affairs) Or CDR global score of 1.0
RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed memory index score of below or equal to (≤) 85
MMSE (Mini-Mental State Examination) greater than or equal to (≥) 22
Amyloid positivity established with either amyloid PET (positron emission tomography), CSF (cerebrospinal fluid) Aβ1-42 or CSF Aβ1-42/Aβ1-40.
If receiving an approved Alzheimer's disease treatment (such as acetylcholinesterase inhibitors, memantine or aducanumab) the dose must have been stable for at least 3 months prior to screening and should not be changed during the study unless medically necessary.

Criterios de exclusión

Brain Magnetic resonance imaging (MRI) (or Computed Tomography (CT)) scan suggestive of clinically significant structural CNS (central nervous system) disease confirmed by central read (e.g. cerebral large-vessel disease \[large vessel (cortical) infarcts greater than (\>) 10 milimeter (mm) in diameter\], prior macro-haemorrhage \[greater than 1 cubic centimetre (cm\^3)\], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus).
Brain MRI (or CT) scan suggestive of strategic infarcts defined as bilateral thalamic lacunar infarcts and singular paramedian thalamic infarcts confirmed by central read.
Evidence of a relevant neurological disorder other than mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type at screening, including but not limited to Parkinson's disease, Lewy body disease, frontotemporal dementia of any type, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive supranuclear palsy, neurosyphilis, human immunodeficiency virus (HIV), learning disability, intellectual disability, hypoxic cerebral damage, or significant head trauma with loss of consciousness that led to persistent cognitive deficits.
Evidence of a clinically relevant or unstable psychiatric disorder, based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, including schizophrenia or other psychotic disorder, or bipolar disorder. A participant with a history of major depression who has not had an episode in the last 24 months before the day of screening and is considered in remission or whose depression is controlled with treatment can be included in the study per investigator's judgement.

Ubicaciones

Instituto Medico Especializado_Capital Federal

Ciudad de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Metabolicas (IDIM)

Buenos Aires, Argentina

Hospital Italiano

Buenos Aires, Argentina

Clínica Nuestra Señora de las Nieves

CABA, Argentina

FLENI

CABA, Argentina

Instituto Privado Kremer

Córdoba, Argentina

Fundación Scherbovsky

Mendoza, Argentina

Ensayo clínico aleatorizado, doble ciego, controlado con placebo que investiga el efecto y la seguridad de semaglutida oral en sujetos con enfermedad de Alzheimer temprana (EVOKE Plus)