NCT07221344 Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease
| NCT ID | NCT07221344 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Arrowhead Pharmaceuticals |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-11-18 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 112 participants in total. It began in 2025-11-18 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07221344 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07221344 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07221344 currently recruiting?
Yes, NCT07221344 is actively recruiting participants. Contact the research team at AROMAPT-SC-1001@arrowheadpharma.com for enrollment information.
Where is the NCT07221344 trial being conducted?
This trial is being conducted at East York, Canada, Toronto, Canada, Grafton, New Zealand.
Who is sponsoring the NCT07221344 clinical trial?
NCT07221344 is sponsored by Arrowhead Pharmaceuticals. The trial plans to enroll 112 participants.
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