RightFit
RecruitingPhase 2

A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations

Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two doses of AP-472 added to levodopa for people with Parkinson's disease whose movement symptoms change while taking levodopa. It compares AP-472 with a placebo, a treatment with no active drug. The study lasts about 12 weeks.

This is a Phase 2 study in people with Parkinson's disease who experience motor fluctuations while taking levodopa. The study will evaluate how effective two different doses of the study drug AP-472 are when added to levodopa treatment, compared with a placebo. The study will last about 12 weeks. Participants will be randomly assigned to receive one of the two doses of AP-472 or a placebo. Neither the participants nor the study staff will know which treatment is given. The study includes a screening period, a 4-week period during which Parkinson's medications must remain stable, and an 8-week treatment period. During the treatment period, limited adjustments to levodopa are allowed if needed.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 30 to 80 years old.
  • Have confirmed Parkinson's disease, with slow movement and symptoms worse on one side of the body.
  • Have mild to moderate Parkinson's disease: stage 3 or lower when medicine is working.
  • Have an average of at least 3 hours of OFF time daily, when medicine is not working well. Home diaries must show at least 2.5 hours each day during the starting period.
  • Score at least 24 on the MoCA, a test of memory and thinking.
  • Be able to walk on your own, with or without a walking aid, and swallow medicine.
  • Have no changes to Parkinson's medicines for at least 4 weeks before screening. For medicines called MAO-B inhibitors, this must be at least 12 weeks.
  • Take levodopa at least 4 times daily for immediate- or controlled-release forms, or at least 3 times daily for extended-release forms such as Rytary or Crexont.

Who can't join

  • Have a condition that causes Parkinson's-like symptoms but is not typical Parkinson's disease.
  • Have had, or plan to have during the study, advanced Parkinson's treatments, such as systems that deliver levodopa or dopamine continuously, or brain surgery for Parkinson's.
  • Have unwanted movements severe enough that the study doctor thinks they would interfere with taking part.
  • Have a history of only certain unwanted movements—called OFF-state, diphasic, myoclonic, or dystonic movements—without typical unwanted movements when a dose works most strongly.
  • Take medicines that block dopamine, except quetiapine at 50 mg a day or less for trouble sleeping.
  • Regularly use as-needed Parkinson's 'rescue' medicines more than 3 times a week.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: Participants must meet all of the following criteria to take part in the study: 1. Be a man or woman between 30 and 80 years of age at the time of screening. 2. Have a diagnosis of Parkinson's disease, confirmed using standard medical criteria, including slowness of movement and symptoms that affect one side of the body more than the other. 3. Have mild to moderate Parkinson's disease, defined as stage 3 or lower on the Hoehn and Yahr scale when medications are working ("ON" state). 4. Experience an average of at least 3 hours of OFF time per day, based on home symptom diaries, with at least 2.5 hours of OFF time each day during the baseline period. 5. Have a Montreal Cognitive Assessment (MoCA) score of 24 or higher at screening. 6. Be able to walk independently, with or without the use of a walking aid. 7. Be able to swallow oral medication. 8. Have been on a stable Parkinson's medication regimen for at least 4 weeks before screening. Medications known as MAO-B inhibitors must have been stable for at least 12 weeks. 9. Be taking levodopa at least four times daily (immediate- or controlled-release formulations) or three times daily (extended-release formulations such as Rytary or Crexont). Key Exclusion Criteria: Participants cannot take part in the study if any of the following apply: 1. Have a form of parkinsonism that is not typical Parkinson's disease, such as secondary or atypical parkinsonism. 2. Have previously received, or plan to receive during the study, advanced Parkinson's therapies such as continuous levodopa or dopamine delivery systems, or Parkinson's disease-related brain surgery. 3. Have dyskinesias (involuntary movements) that are severe enough, in the study doctor's opinion, to interfere with participation. 4. Have a history of only certain types of dyskinesias (such as OFF-state, diphasic, myoclonic, or dystonic dyskinesias) without typical peak-dose dyskinesias. 5. Are currently taking medications that block dopamine, except for low-dose quetiapine (up to 50 mg per day) used for insomnia. 6. Routinely use on-demand "rescue" Parkinson's medications more than three times per week.

Study sites (30)

AR

CA

CO

FL

GA

IN

KS

KY

MA

MI

NC

NM

NY

OH

TN

TX

WA