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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

RecruitingPhase 2

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

Ages 30 to 80 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Appello Pharmaceuticals, Inc. · Participants: 150 · Started: Feb 25, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07432958

Locations in the U.S.

ArkansasUniversity of Arkansas for Medical Sciences (Site #208), Little Rock (Not yet recruiting)
CaliforniaProfound Research LLC (Site #222), Carlsbad
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217), Los Alamitos
Keck Medicine of USC - USC Healthcare Center 2 (Site #221), Los Angeles (Not yet recruiting)
Parkinson's Research Centers of America (Site #218), Palo Alto
ColoradoRocky Mountain Clinical Research - CenExel - PPDS (Site #215), Englewood
FloridaParkinson's Disease & Movement Disorders Center of Boca Raton (Site #227), Boca Raton
UM-UHealth at Boca Raton (Site #226), Boca Raton
Velocity Clinical Research - Hallandale Beach (Site #228), Hallandale
University of Miami (Site #220), Miami
Neurology One (Site #205), Orlando
USF Parkinson's Disease and Movement Disorders Center (Site #206), Tampa
GeorgiaAugusta University Medical Center (Site #212), Augusta
IndianaJosephson Wallack Munshower Neurology PC (Site #231), Indianapolis
KansasThe University of Kansas (KU) (Site #216), Kansas City
KentuckyKentucky Neuroscience Institute (Site #213), Lexington
MassachusettsBeth Israel Deaconess Medical Center (Site #211), Boston
MichiganUniversity of Michigan Health System (UMHS) (Site #202), Ann Arbor
Quest Research Institute - Alcanza - PPDS (Site #201), Farmington Hills
New MexicoUniversity of New Mexico Health Sciences Center (Site #225), Albuquerque
New YorkJoan and Sanford I. Weill Department of Medicine (Site #224), New York
Mount Sinai School of Medicine (Site #209), New York
North CarolinaAsheville Neurology Specialists, P.A. (Site #229), Asheville
Duke Neurological Disorders Clinic (Site #210), Durham
OhioCleveland Clinic (Site #223), Cleveland (Not yet recruiting)
The Ohio State University Wexner Medical Center (site #207), Columbus
TennesseeVanderbilt University Medical Center (Site #204), Nashville
TexasHorizon Clinical Research: Gill Neuroscience - Houston (Site #232), Cypress
Central Texas Neurology Consultants (Site #203), Round Rock
WashingtonEvergreenHealth (Site #219), Kirkland

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.