Study of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's Disease (NCT07221344) | Clinical Trial Compass
RecruitingPhase 1/2
Study of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's Disease
New Zealand112 participantsStarted 2025-11-18
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 prot…
What they're measuring
1
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Over Time