Actively Recruiting
Study of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's Disease
Led by Arrowhead Pharmaceuticals · Updated on 2026-04-15
112
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 before any study procedures
- Participants of childbearing potential must use highly effective contraception and a condom during the study and for at least 90 days after the study or last dose
- Participants must not donate sperm or eggs during the study and for at least 90 days after the study or last dose
- Adults aged 50 to 80 years with clinical diagnosis of early Alzheimer's disease and biomarker confirmation
- On stable doses of Alzheimer's disease medications for at least 8 weeks before screening and during screening until Day 1
- Have a reliable caregiver or trial partner aged 18 or older, willing to accompany to visits and provide accurate information
You will not qualify if you...
- Blood pressure outside specified range in the protocol
- HIV infection positive at screening
- Positive for hepatitis B or C at screening
- Intellectual disability or significant behavioral neuropsychiatric issues
- Clinically significant heart, liver, or kidney disease
- Any contraindications to lumbar puncture
- Known or possible allergy to ARO-MAPT-SC or its ingredients
- Additional criteria may apply per protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site 1
Grafton, Auckland, New Zealand, 1010
Actively Recruiting
Research Team
M
Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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