A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease (TREMHANCE)
7 de agosto de 2026 actualizado por: Sanofi
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 48-week SAR448851 Treatment Followed by Open-label Extension in Participants With Early Alzheimer's Disease
This is a randomized, placebo-controlled Phase 2 study to evaluate the efficacy and safety of SAR448851 in early Alzheimer's disease (AD) participants. The purpose of this study is to measure efficacy and safety with once daily oral SAR448851 compared to placebo in participants with mild cognitive impairment due to AD or mild AD dementia and with evidence of cerebral amyloid pathology.
This Phase 2 study has 2 parts: Part A is a randomized, double-blind, parallel-group, placebo-controlled study with SAR448851 oral once daily. Part B is an open-label extension. All participants who complete Part A may continue to Part B. An optional dose 2 cohort will be considered to evaluate the efficacy and safety of SAR448851 dose 2 oral once daily.
The study duration will be up to 111 weeks for Part A and B, and up to 63 weeks for the dose 2 cohort. The treatment duration will be up to 96 weeks for Part A and B, and up to 48 weeks for the dose 2 cohort.
Up to 160 participants will be included in this study.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
160
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.
Estudio Contacto
- Nombre: Trial Transparency email recommended (Toll free for US & Canada)
- Número de teléfono: option 6 800-633-1610
- Correo electrónico: contact-us@sanofi.com
Ubicaciones de estudio
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Florida
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The Villages, Florida, Estados Unidos, 32162
- Reclutamiento
- Charter Research - Lady Lake- Site Number : 8400004
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Participant must be 55 to 85 years (inclusive) of age, at the time of signing the informed consent.
- Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (National Institute on Aging-Alzheimer's Association [NIA-AA] Stage 3) or mild AD dementia (NIA-AA Stage 4).
- Have a global Clinical Dementia Rating (CDR) score 0.5 to 1.0 and a CDR-Memory Box score ≥ 0.5 at screening.
- Have a study partner who must provide separate written informed consent at screening. Study partner should be >18 years of age, have known participant for at least 1 year, and have a minimum of 8 hours per week contact with participant.
- The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at screening.
Exclusion Criteria:
- The participant has any history of significant neurological disease including but not limited to, frontotemporal dementia, Lewy body dementia, Huntington's disease, serious infection of the brain, Parkinson's disease, multiple concussions, multiple sclerosis, or epilepsy or recurrent seizures (except febrile childhood seizures).
- The participant has evidence of more than 4 microhemorrhages (<10 mm in diameter) or superficial siderosis.
- The participant carries two copies of the apolipoprotein-E epsilon 4 (APOE4) allele (APOE4/4).
- The participant is currently receiving or has previously received any anti-amyloid immunotherapy (including, but not limited to, aducanumab, lecanemab, or donanemab) or triggering receptor expressed on myeloid cells 2 (TREM-2) targeting therapy.
- The participant is currently receiving anticoagulant therapies.
- The participant has had malignancy in the 3 years prior to Screening, excluding basal cell carcinoma, squamous cell carcinoma of the skin, melanoma in situ, Stage 1 or 2 prostate cancer, fully resected renal cell cancers, or cervical carcinoma in situ that has been successfully treated.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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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Experimental: SAR448851
Participants will receive SAR448851 dose 1 or dose 2 oral daily for 48 weeks
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Pharmaceutical form: Capsule Route of administration: Oral
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Comparador de placebos: Placebo
Participants will receive placebo oral daily for 48 weeks
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Forma farmacéutica: Cápsula Vía de administración: Oral
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217
Periodo de tiempo: From baseline to Week 48
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From baseline to Week 48
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Part B: Number of participants with treatment-emergent adverse events (TEAE), including ARIA-E and ARIA-H by brain MRI, laboratory assessments, vital sign measurements, ECGs and the C-SSRS
Periodo de tiempo: From Week 48 to Week 96
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Number of participants experiencing at least one treatment-emergent adverse event (TEAE), including amyloid-related imaging abnormalities with edema (ARIA-E) and amyloid-related imaging abnormalities with hemosiderin (ARIA-H) by brain magnetic resonance imaging (MRI), laboratory assessments, vital sign measurements, electrocardiograms (ECGs) and the Columbia-Suicide Severity Rating Scale (C-SSRS)
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From Week 48 to Week 96
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Part A and optional dose 2 cohort: Change from baseline to Week 48 in plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng)
Periodo de tiempo: From baseline to Week 48
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From baseline to Week 48
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Part A and optional dose 2 cohort: Change from baseline to Week 48 in brain amyloid plaque deposition as measured by amyloid positron emission tomography (PET)
Periodo de tiempo: From baseline to Week 48
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From baseline to Week 48
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Part A and optional dose 2 cohort: Change from baseline to Week 48 in CSF soluble triggering receptor expressed on myeloid cells 2 (sTREM2)
Periodo de tiempo: From baseline to Week 48
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From baseline to Week 48
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Part A and optional dose 2 cohort: Number of participants with TEAEs and serious adverse events (SAEs), and discontinuations due to TEAEs and SAEs (including laboratory assessments, vital sign measurements, ECGs and the C-SSRS)
Periodo de tiempo: From baseline to Week 48
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Number of participants experiencing at least one treatment-emergent adverse event (TEAE), serious adverse event (SAE) or discontinuation due to TEAEs and SAEs (including laboratory assessments, vital sign measurements, electrocardiograms [ECGs] and the Columbia-Suicide Severity Rating Scale [C-SSRS])
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From baseline to Week 48
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Part A and optional dose 2 cohort: Number of participants with ARIA-E and ARIA-H assessed by brain MRIs
Periodo de tiempo: From baseline to Week 48
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Number of participants with amyloid-related imaging abnormalities with edema (ARIA-E) and amyloid-related imaging abnormalities with hemosiderin (ARIA-H) assessed by brain magnetic resonance imaging (MRI).
ARIA event: adverse event causing brain swelling or bleeding that requires close monitoring.
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From baseline to Week 48
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Part A and optional dose 2 cohort: Plasma and CSF concentrations of SAR448851
Periodo de tiempo: From baseline to Week 48
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From baseline to Week 48
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Part B: Change from baseline to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng
Periodo de tiempo: From baseline to Week 96
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Change in Alzheimer's disease (AD) biomarkers: plasma p-tau217, plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng)
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From baseline to Week 96
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Part B: Change from Week 48 to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng
Periodo de tiempo: From Week 48 to Week 96
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Change in Alzheimer's disease (AD) biomarkers: plasma p-tau217, plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng)
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From Week 48 to Week 96
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
28 de julio de 2026
Finalización primaria (Estimado)
31 de julio de 2029
Finalización del estudio (Estimado)
31 de julio de 2029
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de junio de 2026
Publicado por primera vez (Actual)
7 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ACT23645
- 2025-524581-14 (Identificador de registro: CTIS)
- U1111-1328-4936 (Identificador de registro: ICTRP)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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