112 Participants NeededMy employer runs this trial

ARO-MAPT-SC for Alzheimer's Disease

Recruiting at 3 trial locations
MM
Overseen ByMedical Monitor
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Arrowhead Pharmaceuticals
Must be taking: AD-related medications

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ARO-MAPT-SC for individuals with early Alzheimer's disease (AD), focusing on safety and the body's response to the drug compared to a placebo (a harmless substance used for comparison). Researchers aim to learn more about how ARO-MAPT-SC might assist with mild cognitive impairment and mild dementia due to Alzheimer's. The trial involves injections of either the actual treatment or a placebo. Individuals diagnosed with early Alzheimer's disease who are already on stable medication might be suitable candidates. As a Phase 1/Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking Alzheimer's research.

Do I have to stop taking my current medications for the trial?

The trial requires that participants with Alzheimer's disease stay on stable doses of their AD-related medications for at least 8 weeks before starting the trial and throughout the screening period.

Is there any evidence suggesting that ARO-MAPT-SC is likely to be safe for humans?

Research has shown that ARO-MAPT-SC is being tested for safety and effectiveness in treating early Alzheimer's disease. Limited public information exists about its safety in humans because it remains in the early testing stages. Researchers are still determining how well people can tolerate it.

In early trial phases, researchers closely monitor treatments to identify any side effects or problems. If ARO-MAPT-SC progresses to later stages, it typically indicates a reasonable safety level in initial tests. However, specific safety information for ARO-MAPT-SC is not yet available, so participants should consider this when deciding whether to join the trial.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Alzheimer's, which often focus on managing symptoms through drugs like donepezil or memantine, ARO-MAPT-SC works differently by targeting the tau protein, a key player in the disease's progression. This experimental treatment is administered via injection, potentially offering a more direct and effective approach to slowing down or altering the disease pathway itself. Researchers are excited about ARO-MAPT-SC because it might not just manage symptoms but could actually modify the disease, offering hope for a more impactful treatment option.

What evidence suggests that ARO-MAPT-SC might be an effective treatment for Alzheimer's disease?

Research has shown that ARO-MAPT-SC, which participants in this trial may receive, might help individuals with early Alzheimer's disease by targeting tau proteins. These proteins can accumulate in the brain and are linked to Alzheimer's symptoms. Earlier studies found that ARO-MAPT could prevent or even reverse this buildup, potentially slowing or halting the disease's progression. These findings suggest that ARO-MAPT-SC could be a promising option for improving outcomes in people with early Alzheimer's.12456

Are You a Good Fit for This Trial?

This trial is for adults aged 50–75 who are either healthy or have early Alzheimer's disease. Participants must be on stable Alzheimer's medications, have a BMI between 18 and 35, not be pregnant or breastfeeding, and agree to use effective birth control during the study.

Inclusion Criteria

I have been on the same Alzheimer's medication dose for at least 8 weeks.
My BMI is between 18.0 and 35.0.
I am not pregnant or breastfeeding.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ARO-MAPT-SC or placebo injections to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ARO-MAPT-SC

Trial Overview

The study compares ARO-MAPT-SC (an investigational drug) with a placebo to assess safety and how the body processes the drug in both healthy people and those with early Alzheimer's disease.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ARO-MAPT-SCExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arrowhead Pharmaceuticals

Lead Sponsor

Trials
45
Recruited
6,200+

Citations

NCT07221344 | Study of ARO-MAPT-SC in Healthy ...

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-MAPT-SC

Press Release Details

ARO-MAPT may prevent or reverse tau protein accumulation in subjects with early Alzheimer's disease, potentially preventing or slowing the ...

Arrowhead files to begin clinical trials of ARO-MAPT

ARO-MAPT has potential to prevent or slow disease progression. In preclinical studies, investigational ARO-MAPT demonstrated potent and long- ...

ARO-MAPT - Drug Targets, Indications, Patents

“Only two disease-modifying therapies have been approved to treat Alzheimer's, and both carry safety warnings, offer only modest efficacy, and ...

Arrowhead Pharmaceuticals Advances Alzheimer's ...

The study aims to assess the safety and effectiveness of ARO-MAPT-SC, a potential treatment for early Alzheimer's disease, Alzheimer's disease ...

Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ...

AROMAPT-SC-1001 (NCT07221344) a Phase 1/2a placebo-controlled dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and ...