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

NCT ID
NCT07221344
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Arrowhead Pharmaceuticals
Conditions
Alzheimer Disease, Alzheimer Disease, Early Onset

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 112 participants (Estimated).

What is being studied

  • Drug: ARO-MAPT-SC
  • Drug: Placebo

Who may be eligible

Ages
18 Years to 80 Years
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following eligibility criteria.

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 non-disease-modifying AD medications, the doses must be stable for ≥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. * 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.

Study locations

4 study locations are listed.

Recruiting site status is explicitly provided for 4 locations; 4 are listed as Recruiting.

Countries: Canada, New Zealand

  • Ontario, Canada: 2
  • Quebec, Canada: 1
  • Auckland, New Zealand: 1

Sample of listed locations

  • Research Site 3 — East York, Ontario, M4G 3E8, Canada — Recruiting
  • Research Site 2 — Toronto, Ontario, M3B2S7, Canada — Recruiting
  • Research Site 4 — Montreal, Quebec, H3G 1H9, Canada — Recruiting
  • Research Site 1 — Grafton, Auckland, 1010, New Zealand — Recruiting

Study details

Start date
November 18, 2025
Primary completion date
June 1, 2027
Completion date
June 1, 2027
First posted
October 27, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07221344
Registry last updated
September 18, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07221344 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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