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Идёт набор NCT07221344

Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease

Фаза I / Фаза II С лечением Alzheimer Disease Alzheimer Disease, Early Onset

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ARO-MAPT-SC, Placebo.
Кому может быть актуально
Состояния в реестре: Alzheimer Disease, Alzheimer Disease, Early Onset. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада, Новая Зеландия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1/2a Placebo-Controlled Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's Disease

Обзор

Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics 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.

Вмешательства

  • Препарат ARO-MAPT-SC
    • single or multiple doses of ARO-MAPT-SC by subcutaneous (SC) injection
  • Препарат Placebo
    • calculated volume to match active treatment by SC administration

Первичные конечные точки

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Over Time [Срок оценки: Through End of Study (EOS), Day 270]
Вторичные конечные точки (12)
  • PK of ARO-MAPT-SC: Maximum Observed Plasma Concentration (Cmax) [Срок оценки: Through 48 hours postdose]
  • PK of ARO-MAPT-SC: Time to Maximum Plasma Concentration (Tmax) [Срок оценки: Through 48 hours postdose]
  • PK of ARO-MAPT-SC: Area Under the Plasma Concentration (AUC) Versus Time Curve From Time Zero to 24 Hours (AUC0-24) [Срок оценки: Through 24 hours postdose]
  • PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero to 48 Hours (AUC0-48) [Срок оценки: Through 48 hours postdose]
  • PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUC0-t) [Срок оценки: Through 48 hours postdose]
  • PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) [Срок оценки: Through 48 hours post-dose]
  • PK of ARO-MAPT-SC: Apparent Terminal Elimination Half-life (t1/2) [Срок оценки: Through 48 hours postdose]
  • PK of ARO-MAPT-SC: Apparent Systemic Clearance (CL/F) [Срок оценки: Through 48 hours postdose]
  • PK of ARO-MAPT-SC: Apparent Terminal-phase Volume of Distribution (Vz/F) [Срок оценки: Through 48 hours postdose]
  • PK of ARO-MAPT-SC: Amount Excreted (Ae) of Unchanged Drug in Urine From Time Zero to 24 Hours Postdose [Срок оценки: Through 24 hours postdose]
  • PK of ARO-MAPT-SC: Percentage of Administered Drug Recovered (Fe) in Urine From Time Zero to 24 Hours Postdose [Срок оценки: Through 24 hours postdose]
  • PK of ARO-MAPT-SC: Renal Clearance (CLR) [Срок оценки: Through 24 hours postdose]

Критерии участия

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 study specific procedures
  • Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later

Inclusion Criteria (Alzheimer's Disease):

  • 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 AD medications, the doses must be stable for ≥weeks prior to Screening.

a. Participants with early AD are not required to be on AD medications.

  • Have a reliable and competent caregiver or trial partner who is ≥18 years of age, able and willing to accompany the participant to study 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 study in order to provide accurate and reliable information relevant to study 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Канада · 2 центра
  • Research Site 3 — East York
  • Research Site 2 — Toronto
Новая Зеландия · 1 центр
  • Research Site 1 — Grafton

Идентификаторы

NCT: NCT07221344 · AROMAPT-SC-1001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗