RecruitingPhase 1Phase 2NCT07221344

Study of ARO-MAPT-SC in Healthy Subjects and Subjects 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

Sponsor

Arrowhead Pharmaceuticals

Enrollment

112 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease Alzheimer Disease, Early Onset

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called ARO-MAPT-SC, which targets a protein (MAPT/tau) involved in Alzheimer's disease. The study includes both healthy volunteers (to check safety and dosing) and people with early Alzheimer's disease. **You may be eligible if...** - Your BMI is between 18 and 35 - You are not pregnant or breastfeeding - You agree to use reliable contraception during and for 90 days after the study - For the Alzheimer's group: You are between 50 and 75 years old with a clinical diagnosis of early Alzheimer's, confirmed by blood, spinal fluid, or brain imaging markers **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have significant medical conditions that would affect the study - You are unwilling or unable to follow contraception requirements - For the Alzheimer's group: Your disease is not confirmed by biomarkers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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