A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease
16 de septiembre de 2026 actualizado por: AbbVie
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-1758 in Participants With Alzheimer's Disease
Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. The purpose of this study is to test how safe ABBV-1758 is, how well it works, how the body processes it and what effects it has on the body.
ABBV-1758 is an investigational drug being developed for the treatment of Alzheimer's disease. This study is conducted in 3 stages. Stage A is a multiple ascending dose study with a 1 in 5 chance (4:1 randomization) that participants are assigned to receive placebo. Stage B is a dose expansion phase, also using 4:1 randomization for ABBV-1758 or placebo. Stage C enrolls Japanese and Chinese participants with the same randomization scheme. Approximately 210 participants will be enrolled at about 55 sites in the United States, China, and Japan.
Participants will receive intravenous (IV) or subcutaneous (SC) doses of ABBV-1758 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for additional 12 weeks in the Follow-up Period. Participants will have the option of participating in a 12-month, blinded Extension Period receiving ABBV-1758 or placebo based on amyloid PET results.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The safety of the treatment will be checked by medical assessments, blood tests, and completing questionnaires.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
210
Fase
- Fase 2
- Fase 1
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: ABBVIE CALL CENTER
- Número de teléfono: 844-663-3742
- Correo electrónico: abbvieclinicaltrials@abbvie.com
Ubicaciones de estudio
-
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California
-
Irvine, California, Estados Unidos, 92614
- Reclutamiento
- Irvine Center for Clinical Research /ID# 277752
-
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Colorado
-
Boulder, Colorado, Estados Unidos, 80301
- Reclutamiento
- Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856
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Florida
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Bradenton, Florida, Estados Unidos, 34207
- Reclutamiento
- Key Clinical Research LLC /ID# 277800
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Contacto:
- Site Coordinator
- Número de teléfono: 941-241-5539
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Clermont, Florida, Estados Unidos, 34711
- Reclutamiento
- K2 Medical Research - Clermont /ID# 277859
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Lady Lake, Florida, Estados Unidos, 32159
- Reclutamiento
- K2 Medical Research - The Villages /ID# 278290
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Stuart, Florida, Estados Unidos, 34997
- Reclutamiento
- Alzheimer'S Research And Treatment Center - Stuart /ID# 278206
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Wellington, Florida, Estados Unidos, 33414
- Reclutamiento
- Alzheimer's Research And Treatment Center - Wellington /ID# 277749
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Contacto:
- Site Coordinator
- Número de teléfono: (561) 209-2400
-
Winter Park, Florida, Estados Unidos, 32789
- Reclutamiento
- Conquest Research - Winter Park /ID# 277760
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Contacto:
- Site Coordinator
- Número de teléfono: 407-916-0060
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Massachusetts
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Watertown, Massachusetts, Estados Unidos, 02472
- Reclutamiento
- Adams Clinical /ID# 277754
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-
Tennessee
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Cordova, Tennessee, Estados Unidos, 38018
- Reclutamiento
- Neurology Clinic - Cordova /ID# 277790
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-
Texas
-
Dallas, Texas, Estados Unidos, 75231
- Reclutamiento
- Kerwin Medical Center /ID# 277788
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Contacto:
- Site Coordinator
- Número de teléfono: 972-433-9100
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-
-
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100053
- Reclutamiento
- Xuanwu Hospital Capital Medical University /ID# 283310
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510260
- Reclutamiento
- The Second Affiliated Hospital of Guangzhou Medical University /ID# 284295
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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:
Participants meeting all the following criteria for Alzheimer's disease (AD):
- In regions where timely testing is feasible (e.g., results available within 4 weeks of Visit 1), plasma biomarker that is predictive of elevated brain amyloid at Screening for participants that do not have known elevated brain amyloid based on previous amyloid positron emission tomography (PET) results.
- Participants with amyloid positron emission tomography PET scan results consistent with significant amyloid pathology (as determined by a Centiloid value of 50 or higher).
- Participants must have a Mini-Mental State Examination (MMSE) score of 20 or higher at Screening.
Exclusion Criteria:
- Participants with screening magnetic resonance imaging (MRI) that show evidence of another potential etiology for progressive dementia.
- Participants who have any current serious conditions or illnesses that are not adequately controlled, or any conditions that, in the investigator's opinion, could interfere with the analyses in this study, including but not limited to psychiatric, neurologic (other than AD), cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, immunologic, or hematologic, metabolic, pulmonary, ophthalmologic, dermatologic, and/or any history of abnormal laboratory results that are indicative of significant disease(s).
- Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.
Participants with other significant pathological findings on brain MRI at screening, including but not limited to:
- Evidence of vasogenic edema
- 4 or more microhemorrhages (defined as 10 mm or less at the greatest diameter)
- Any macrohemorrhage (defined as greater than 10 mm at the greatest diameter)
- Any superficial siderosis
- Severe white matter disease
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 Secuencial
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Stage A-ABBV-1758 Dose A
Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W).
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Experimental: Stage A-ABBV-1758 Dose B
Participants will receive ABBV-1758 dose B Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Experimental: Stage A-ABBV-1758 Dose C
Participants will receive ABBV-1758 dose C Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Experimental: Stage A-ABBV-1758 Dose D
Participants will receive ABBV-1758 dose D Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Experimental: Stage B- ABBV-1758 - Expanded Cohort 1
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Experimental: Stage B- ABBV-1758- Expanded Cohort 2
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Experimental: Stage C- ABBV-1758 - Japanese Cohort 1
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Experimental: Stage C- ABBV-1758- Japanese Cohort 2
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Experimental: Stage C- ABBV-1758-Chinese Cohort
Participants will receive ABBV-1758 dose determined in Stage A Q4W.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparador de placebos: Placebo for ABBV-1758 Dose A
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparador de placebos: Placebo for ABBV-1758 Dose B
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparador de placebos: Placebo for ABBV-1758 Dose C
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparador de placebos: Placebo for ABBV-1758 Dose D
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparador de placebos: Placebo for ABBV-1758 - Expanded Cohort 1
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparador de placebos: Placebo for ABBV-1758- Expanded Cohort 2
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparador de placebos: Placebo for ABBV-1758 - Japanese Cohort 1
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparador de placebos: Placebo for ABBV-1758- Japanese Cohort 2
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
|
Comparador de placebos: Placebo for ABBV-1758- Chinese Cohort
Participants will receive Placebo for ABBV-1758.
|
Intravenous (IV) or Subcutaneous (SC)
Subcutaneous (SC)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Experiencing Adverse Events (AEs)
Periodo de tiempo: Up to approximately 40 weeks
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment.
The investigator assesses the relationship of each event to the use of study drug.
|
Up to approximately 40 weeks
|
|
Percentage of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results
Periodo de tiempo: Up to approximately 40 weeks
|
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
|
Up to approximately 40 weeks
|
|
Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Periodo de tiempo: Up to approximately 40 weeks
|
Amyloid related imaging abnormalities represent a spectrum of magnetic resonance imaging findings primarily observed in participants undergoing treatment with anti-amyloid therapies.
|
Up to approximately 40 weeks
|
|
Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Periodo de tiempo: Up to approximately 40 weeks
|
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
|
Up to approximately 40 weeks
|
|
Percentage of Participants with Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters
Periodo de tiempo: Up to approximately 40 weeks
|
12-lead resting ECGs will be recorded.
Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
|
Up to approximately 40 weeks
|
|
Percentage of Participants Experiencing Any Suicidal Ideation or Suicidal Behavior As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Periodo de tiempo: Up to approximately 40 weeks
|
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
|
Up to approximately 40 weeks
|
|
Stage A, B, and C: Change from Baseline in Brain Amyloid Load
Periodo de tiempo: Up to approximately 28 Weeks
|
Measured by amyloid positron emission tomography (PET)
|
Up to approximately 28 Weeks
|
|
Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758
Periodo de tiempo: Up to approximately 40 weeks
|
Cmax of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Time to Cmax (Tmax) of ABBV-1758
Periodo de tiempo: Up to approximately 40 weeks
|
Tmax of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Trough Concentration measured at the end of a dosing interval at steady state (Ctrough) of ABBV-1758
Periodo de tiempo: Up to approximately 40 weeks
|
Ctrough of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of ABBV-1758
Periodo de tiempo: Up to approximately 40 weeks
|
AUCtau of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758
Periodo de tiempo: Up to approximately 40 weeks
|
Cav,ss of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758
Periodo de tiempo: Up to approximately 40 weeks
|
AUCtau of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Total Body Clearance (CL) of ABBV-1758
Periodo de tiempo: Up to approximately 40 weeks
|
CL of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Apparent Clearance (CL/F) of ABBV-1758
Periodo de tiempo: Up to approximately 40 weeks
|
CL/F of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Volume of Distribution at Steady-State (Vss)
Periodo de tiempo: Up to approximately 40 weeks
|
Vss of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)
Periodo de tiempo: Up to approximately 40 weeks
|
Vz of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758
Periodo de tiempo: Up to approximately 40 weeks
|
β of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1758
Periodo de tiempo: Up to approximately 40 weeks
|
Terminal phase elimination half-life of ABBV-1758
|
Up to approximately 40 weeks
|
|
Stage A and C: Effective Half-Life (T1/2,eff)
Periodo de tiempo: Up to approximately 40 weeks
|
T1/2,eff of ABBV-1758
|
Up to approximately 40 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: ABBVIE INC., AbbVie
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)
15 de mayo de 2026
Finalización primaria (Estimado)
1 de octubre de 2030
Finalización del estudio (Estimado)
1 de octubre de 2030
Fechas de registro del estudio
Enviado por primera vez
15 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de mayo de 2026
Publicado por primera vez (Actual)
20 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M25-804
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
AbbVie is committed to responsible clinical trial data sharing.
This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Marco de tiempo para compartir IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Criterios de acceso compartido de IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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
producto fabricado y exportado desde los EE. UU.
No
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. .