150 Participants NeededMy employer runs this trial

AP-472 for Parkinson's Disease

Recruiting at 54 trial locations
AB
Overseen ByAnnie Blobaum, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Appello Pharmaceuticals, Inc.
Must be taking: Levodopa
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, AP-472, to determine its effectiveness for people with Parkinson's disease who experience movement problems despite taking levodopa, a common Parkinson’s medication. Participants will receive either a low dose, a high dose, or a placebo (a non-active pill) to compare the effects. The researchers aim to assess whether AP-472 improves symptoms over 12 weeks. This trial may suit individuals diagnosed with Parkinson's who have movement issues despite regular levodopa use and experience at least 3 hours of "OFF" time (when symptoms return) daily. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You will need to keep your Parkinson's medications stable for 4 weeks before starting the treatment, and you can make limited adjustments to levodopa during the treatment period. Other medications should remain stable as specified in the trial criteria.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AP-472 offers potential benefits. In animal studies, it reached the brain and improved movement issues such as stiffness and difficulty moving. Earlier studies with healthy adults tested AP-472 to ensure safety. Researchers conducted these studies in a controlled environment to monitor side effects. Although not all details from these studies are available, the progression of AP-472 to the current study suggests it was generally safe, with serious side effects being rare or manageable.

Since this study now focuses on individuals with Parkinson's disease, AP-472 has already passed some safety checks. Participants should still consult the study team about any concerns to understand possible risks.12345

Why are researchers excited about this trial's treatments for Parkinson's disease?

Researchers are excited about AP-472 for Parkinson's Disease because it offers a potentially new approach to managing symptoms. Unlike traditional treatments like Levodopa or dopamine agonists that primarily aim to replenish dopamine levels, AP-472 may work through a different mechanism, possibly targeting underlying pathways in the brain. This could mean a more comprehensive approach to treatment, potentially leading to improved symptom control and fewer side effects. Additionally, the trial is exploring both low and high doses, which could provide flexibility in tailoring treatment to individual patient needs.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

Studies have shown that AP-472 could benefit people with Parkinson's disease. This trial will evaluate various dosages of AP-472, including low and high doses, to assess its effectiveness. AP-472 boosts a specific brain area called mGlu4, which can enhance movement control when combined with levodopa. In animal studies, AP-472 reached the brain and alleviated movement problems, suggesting it may reduce periods when levodopa is less effective. Research indicates that AP-472 might offer more consistent relief from movement issues.12467

Are You a Good Fit for This Trial?

This trial is for people aged 30–80 with mild to moderate Parkinson's disease who have motor fluctuations while taking levodopa. Participants must be able to walk, take oral meds, and have stable medication for at least 4 weeks. Those with severe dyskinesia or other forms of parkinsonism can't join.

Inclusion Criteria

I take levodopa at least four times daily or three times if it's extended-release.
Have a Montreal Cognitive Assessment (MoCA) score of 24 or higher at screening
I can walk on my own, with or without a walking aid.
See 6 more

Exclusion Criteria

I have had or will have advanced Parkinson's treatments.
Have dyskinesias that are severe enough to interfere with participation
Have a history of certain types of dyskinesias without typical peak-dose dyskinesias
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stabilization

Parkinson's medications must remain stable

4 weeks

Treatment

Participants receive one of two doses of AP-472 or placebo

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AP-472

Trial Overview

The study tests two different doses of AP-472 added to regular levodopa treatment versus a placebo in people with Parkinson's disease over about 12 weeks. Participants are randomly assigned and neither they nor the staff know which treatment they're getting.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Low DoseExperimental Treatment2 Interventions
Group II: High DoseExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Appello Pharmaceuticals, Inc.

Lead Sponsor

Citations

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