ReclutandoNCT07221344Registro de ClinicalTrials.gov

Trial of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease or Primary Tauopathies

Alzheimer Disease · Tauopathies · Frontotemporal Dementia · Progressive Supranuclear Palsy

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 1 / Fase 2
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: Aceptados
Participantes: 160 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

Trial to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARO-MAPT-SC compared to placebo in adult healthy volunteers and in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment due to AD and mild AD dementia, as well as primary tauopathies, including microtubule associated protein tau -related frontotemporal dementia (MAPT-FTD) and progressive supranuclear palsy- Richardson syndrome (PSP-RS).

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria (All Participants):

Body mass index between 18.0 and 35.0 kilograms (kg)/square meter (m\^2) at Screening
Not pregnant or breast-feeding
Able and willing to provide written informed consent prior to the performance of any trial specific procedures
Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the trial and for at least 90 days following the end of the trial or last dose of trial drug, whichever is later; participants must not donate sperm or eggs during the trial and for at least 90 days following the end of the trial or last dose of trial drug whichever is later

Inclusion Criteria (Early AD):

Adults aged 50 to ≤80 years of age with a clinical diagnosis of early AD and plasma, CSF, or imaging biomarkers consistent with the diagnosis
If participant is on non-disease-modifying AD medications, the doses must be stable for ≥8 weeks prior to Screening.

1. Participants with early AD are not required to be on AD medications.
2. Participants previously treated or currently receiving anti-amyloid therapies, including lecanemab and donanemab, are not eligible.

Inclusion Criteria (MAPT-FTD)

Adults ≥18 years of age with Clinical Dementia Rating plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration-Neuropsychiatric and Motor domains Sum of Boxes Global Score of 0.5 or 1 at Screening
Frontotemporal Lobar Degeneration (F-causative MAPT mutation, based on source verifiable medical records.
If the participant is on medications for symptomatic management of MAPT-FTD, the doses must be stable for ≥8 weeks prior to Screening.

Inclusion Criteria (PSP-RS)

Adults ≥41 to ≤86 years of age with clinical diagnosis of probable PSP-RS phenotype as defined by the 2017 Movement Disorder Society criteria (Höglinger 2017) with symptom onset ≥40 to ≤85 years of age
Presence of PSP symptoms ≤3 years at Screening (occurring newly and subsequently progressing during the clinical course in the absence of another identifiable cause) as determined by the Investigator
Mini-Mental Status Examination (MMSE) score of 20 to 30 (inclusive) at Screening
Able to walk at least 10 steps with minimal assistance (eg, one arm for safety, but not postural support)
Reside at home or in the community (assisted living is acceptable); outside of a skilled nursing facility or dementia care facility at the time of screening, with no planned admissions to such a facility at time of Screening.
If the participant is on medications for symptomatic management of PSP-RS, the doses must be stable for ≥8 weeks prior to Screening.

Inclusion Criteria (AD and primary tauopathies)

Have a reliable and competent caregiver or trial partner who is ≥18 years of age, able and willing to accompany the participant to trial visits involving informant-based assessments, to be available to site staff by telephone as needed, and in the opinion of the Investigator, be sufficiently familiar with the participant throughout the trial in order to provide accurate and reliable information relevant to trial outcome measures

Exclusion Criteria (All Participants):

Blood pressure outside of specified range in the protocol
Human immunodeficiency virus (HIV) infection (seropositive at Screening)
Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening
Intellectual disability or significant behavioral neuropsychiatric manifestation
Clinically significant cardiac, liver, or renal disease
Any contraindications to lumbar puncture
Known allergy or possible allergy to either ARO-MAPT-SC or to its excipients

Note: Additional inclusion/exclusion criteria may apply per protocol.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento cuádruple

ARO-MAPT-SC

ARO-MAPT-SC injection

Drug: ARO-MAPT-SC

Placebo

Sterile normal saline (0.9%)

Drug: Placebo

ARO-MAPT-SC DRUG

• single or multiple doses of ARO-MAPT-SC by subcutaneous (SC) injection

Placebo DRUG

• calculated volume to match active treatment by SC administration

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.