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Набира участници Фаза 1/2 NCT07221344

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

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Alzheimer Disease Alzheimer Disease, Early Onset

Спонсор: Arrowhead Pharmaceuticals

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria (All Participants): * Body mass index between 18.0 and 35.0 kg/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 * On stable doses of AD-related medications for at least 8 weeks prior to Screening Visit and throughout the Screening period until Day 1 * 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.
Места на провеждане 1
New Zealand (1)
Research Site 1
Grafton , Auckland
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
18.11.2025
Крайна дата
01.06.2027
Регистрационен номер
NCT07221344
Източник
anzctr
Запитване за медицински туризъм

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