RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's Disease

This research study is investigating a new medication called ARO-MAPT-SC. It's designed to understand if this medication is safe and well-tolerated in both healthy people and those with early signs of Alzheimer's disease. Researchers will also look at how the body processes the medication and if it has any effects on the disease itself. They are comparing it to a placebo, which is a dummy treatment, to see the true effects of ARO-MAPT-SC. The aim is to find better ways to help people living with Alzheimer's.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Arrowhead Pharmaceuticals

Enrolment target

112

Start

18 Nov 2025

Estimated completion

01 Jun 2027

Alzheimer Disease Alzheimer Disease, Early Onset

What is this study about?

This study is a clinical trial exploring a new potential treatment called ARO-MAPT-SC. Alzheimer's disease is a condition that affects memory and thinking. Early Alzheimer's includes people who have mild memory problems that are linked to Alzheimer's, or those with very early signs of Alzheimer's dementia.

The main goals of this research are to find out if ARO-MAPT-SC is safe for people to take and if their bodies handle it well. The study also aims to understand how much of the medicine stays in the body over time and if it has any helpful effects on the disease process. To do this, some people will receive ARO-MAPT-SC, while others will receive a placebo – a treatment that looks the same but contains no active medicine. This allows researchers to accurately compare the effects of the new medication.

By carefully studying ARO-MAPT-SC, scientists hope to learn more about its potential to slow down or even stop the progression of Alzheimer's disease. Even if this specific study doesn't lead to a new treatment right away, the information gathered is vital for developing future medicines and understanding this complex condition better.

Key takeaways

This study is testing a new medication for early Alzheimer's disease.
It aims to check if the new drug is safe, well-tolerated, and how it works in the body.
Both healthy volunteers and people with early Alzheimer's can participate.
Some participants will receive the new drug, and others will receive a placebo.
Participation involves regular clinic visits and various health checks.
Your involvement could help advance future treatments for Alzheimer's disease.

Who may be eligible?

This study is looking for adults aged between 18 and 80. If you have early Alzheimer's disease, you must be between 50 and 80 years old and have a confirmed diagnosis through tests like blood checks, spinal fluid analysis, or brain scans. You also need to be taking any current Alzheimer's medications at a steady dose for at least two months before joining.

All participants must be generally healthy, not pregnant or breastfeeding, and have a body weight that falls within a certain range. If you might be able to have children, you must agree to use effective birth control during and for 90 days after the study, and not donate sperm or eggs during this time.

There are also some reasons why you might not be able to join. These include having certain heart, liver, or kidney problems, some blood conditions like HIV or hepatitis, uncontrolled high blood pressure, or a history of significant mental health issues. If you have any allergies to the study drug or need a lumbar puncture (spinal tap) and can't have one, you might also not be eligible. For those with Alzheimer's, you'll need a trusted caregiver or study partner aged 18 or over who can come to appointments with you and provide information.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 80 years old?
If you have Alzheimer's, are you between 50 and 80 and have an early diagnosis?
Are you generally healthy and not currently pregnant or breastfeeding?
Are you willing to use effective birth control if you can have children?
Do you have a caregiver or study partner if you have Alzheimer's?
Do you have any significant heart, liver, or kidney problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new study medication, ARO-MAPT-SC, or a placebo, which is a dummy medication. Both are given in the same way. You would have regular visits to the study clinic, where doctors and nurses would check your health, take blood and other samples, and ask you questions about how you are feeling and if you are experiencing any changes.

These visits will involve different tests, which might include memory and thinking assessments, physical exams, and possibly procedures like blood tests, urine tests, or even a lumbar puncture (a spinal fluid test). The exact number of visits and the duration of the study would be explained in full detail by the study team. Throughout the study, you would be closely monitored by medical professionals, and they would be available to answer any questions you have.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might not directly benefit from this study, but your participation could help researchers learn more about Alzheimer's and develop future treatments that may help others. Potential risks could include side effects from the study medication, discomfort from tests like blood draws or lumbar punctures, or inconvenience from the study visits. The doctors and nurses overseeing the study will explain all known risks and monitor you closely for any unexpected problems. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Research Site 3
Verified postcode
East York, Canada· Recruiting
Research Site 2
Verified postcode
Toronto, Canada· Recruiting
Research Site 1
Verified postcode
Grafton, New Zealand· Recruiting

Common questions

What is ARO-MAPT-SC?

ARO-MAPT-SC is a new medication being tested in this study to see if it can help people with early Alzheimer's disease.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the study medication but doesn't contain any active drug. It helps researchers compare the real effects of the new medicine.

Who is supervising this study?

This study is being run by medical doctors and scientists who specialize in Alzheimer's disease and clinical research.

Will I know if I'm getting the drug or the placebo?

Usually, in studies like this, neither you nor the study team will know until after the study is over, to ensure the results are fair and unbiased.

What if I feel unwell during the study?

If you feel unwell or have any concerns during the study, you should tell the study team immediately. They will monitor your health closely.

How to find out more

Medical Monitor

aromapt-sc-1001@arrowheadpharma.com 626-304-3400 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.