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Try two doses of AP-472 added to levodopa for Parkinson's 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

PHASE2 · Appello Pharmaceuticals, Inc. · NCT07432958

This trial will test whether adding one of two doses of the experimental pill AP-472 to levodopa can reduce daily OFF time in people with Parkinson's who experience motor fluctuations.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment150 (estimated)
Ages30 Years to 80 Years
SexAll
SponsorAppello Pharmaceuticals, Inc. (industry)
Locations25 sites (Little Rock, Arkansas and 24 other locations)
Trial IDNCT07432958 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 study lasting about 12 weeks that compares two doses of AP-472 versus placebo when given alongside participants' regular levodopa. After screening and a 4-week period with stable Parkinson's medications, participants are randomly assigned to one of the study arms for an 8-week treatment period. Limited adjustments to levodopa are allowed during treatment if clinically needed. The trial enrolls people with mild-to-moderate Parkinson's who have at least about 3 hours of OFF time per day based on home diaries.

Who should consider this trial

Good fit: Ideal candidates are people aged 30–80 with a confirmed diagnosis of Parkinson's, mild-to-moderate disease (Hoehn and Yahr ≤3 ON), at least ~3 hours of OFF time per day, MoCA ≥24, ability to walk independently and swallow oral meds, and a stable Parkinson's medication regimen for at least 4 weeks.

Not a fit: People with more advanced Parkinson's (Hoehn and Yahr >3 ON), notable cognitive impairment (MoCA <24), little or no daily OFF time, or who cannot take oral medication are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, AP-472 added to levodopa could reduce OFF time and improve day-to-day mobility for people with Parkinson's.

How similar studies have performed: Other adjunctive oral treatments for levodopa-related OFF time have shown benefit, but AP-472 is a novel experimental agent without large-phase proof of efficacy yet.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Little Rock, Arkansas and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Parkinson Disease, Parkinson's Disease, Motor Fluctuations, OFF Time, Wearing-Off, Dyskinesia, AP-472, Adjunctive Therapy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.