Study of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's Disease
NCT ID: NCT07221344
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
112 participants
INTERVENTIONAL
2025-11-18
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease
NCT03131453
A Multiple Ascending Dose Study of BPN14770 in Healthy Young and Elderly Male or Female Subjects
NCT02840279
BPN14770 Single Ascending Dose Study in Healthy Male and Female Subjects
NCT02648672
A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects
NCT04745104
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
NCT04592874
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ARO-MAPT-SC
ARO-MAPT-SC injection
ARO-MAPT-SC
• single or multiple doses of ARO-MAPT-SC by subcutaneous (SC) injection
Placebo
Sterile normal saline (0.9%)
Placebo
• calculated volume to match active treatment by SC administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ARO-MAPT-SC
• single or multiple doses of ARO-MAPT-SC by subcutaneous (SC) injection
Placebo
• calculated volume to match active treatment by SC administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 75 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arrowhead Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site 1
Grafton, Auckland, New Zealand
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AROMAPT-SC-1001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.