NCT07221344RecruitingPhase 1/2
Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 23 Oct 2025
- Start date
- 18 Nov 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Arrowhead Pharmaceuticals
- Diseases
- Alzheimer disease
- NCT number
- NCT07221344
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 112
- From 18 Nov 2025 to the primary completion date, Jun 2027
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Human immunodeficiency virus (HIV) infection (seropositive at Screening)
- Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening
- Clinically significant cardiac, liver, or renal disease
- Known allergy or possible allergy to either ARO-MAPT-SC or to its excipients
- Note: Additional inclusion/exclusion criteria may apply per protocol.
Other
- Blood pressure outside of specified range in the protocol
- Intellectual disability or significant behavioral neuropsychiatric manifestation
- Any contraindications to lumbar puncture
Who the study is looking for
- 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
- 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.
- Participants with early AD are not required to be on AD medications.
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | East York | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Grafton | New Zealand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.