---
title: Reduce wearing off between doses
nct_id: NCT07432958
phase: PHASE2
status: RECRUITING
sponsor: Appello Pharmaceuticals, Inc.
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07432958"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07432958"
last_fetched: "2026-05-10T14:06:43.216Z"
source: "Parkinson's Pathways (curated)"
---
# Reduce wearing off between doses

**Goal (in five words):** Reduce wearing off between doses

**Official Title:** 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

**Trial ID:** [NCT07432958](https://clinicaltrials.gov/study/NCT07432958)

## Key Facts

- **Phase:** PHASE2
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Appello Pharmaceuticals, Inc.
- **Target Enrollment:** 150 participants
- **Start Date:** 2026-02-25
- **Completion Date:** 2027-09-03
- **Conditions:** Parkinson Disease
- **Interventions:** AP-472, Placebo
- **Intervention Types:** DRUG, OTHER

## Summary For Families

Researchers are testing whether adding AP-472 to regular levodopa can reduce daily OFF time and smooth the motor ups and downs that happen as levodopa wears off. AP-472 is an experimental oral drug given in two different doses alongside your usual levodopa, intended to enhance or prolong levodopa's effects on brain dopamine pathways so you spend more time in the ON state; each dose is compared to placebo. The trial seeks people aged 30 to 80 with mild to moderate Parkinson's (Hoehn and Yahr stage 3 or lower when ON) who have about 3 or more hours of OFF time per day, a MoCA score of 24 or higher, can walk and swallow pills, and are on a stable Parkinson medication regimen with frequent levodopa dosing, while excluding those with atypical parkinsonism, prior advanced device or brain surgery, or severe dyskinesias.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

### Full 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.
```

## Locations (25)

- University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States _(34.7465, -92.2896)_
- Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS, Los Alamitos, California, United States _(33.8031, -118.0726)_
- Keck Medicine of USC - USC Healthcare Center 2, Los Angeles, California, United States _(34.0522, -118.2437)_
- North County Neurology Associates, Oceanside, California, United States _(33.1959, -117.3795)_
- Parkinson's Research Centers of America, Palo Alto, California, United States _(37.4419, -122.1430)_
- Rocky Mountain Clinical Research - CenExel - PPDS, Englewood, Colorado, United States _(39.6478, -104.9878)_
- University of Miami, Miami, Florida, United States _(25.7743, -80.1937)_
- Neurology One, Orlando, Florida, United States _(28.5383, -81.3792)_
- USF Parkinson's Disease and Movement Disorders Center, Tampa, Florida, United States _(27.9475, -82.4584)_
- Augusta University Medical Center, Augusta, Georgia, United States _(33.4710, -81.9748)_
- The University of Kansas (KU), Kansas City, Kansas, United States _(39.1142, -94.6275)_
- Kentucky Neuroscience Institute, Lexington, Kentucky, United States _(37.9887, -84.4777)_
- Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States _(42.3584, -71.0598)_
- University of Michigan Health System (UMHS), Ann Arbor, Michigan, United States _(42.2776, -83.7409)_
- Quest Research Institute - Alcanza - PPDS, Farmington Hills, Michigan, United States _(42.4853, -83.3772)_
- University of New Mexico Health Sciences Center, Albuquerque, New Mexico, United States _(35.0845, -106.6511)_
- Mount Sinai School of Medicine, New York, New York, United States _(40.7143, -74.0060)_
- Joan and Sanford I. Weill Department of Medicine, New York, New York, United States _(40.7143, -74.0060)_
- Duke Neurological Disorders Clinic, Durham, North Carolina, United States _(35.9940, -78.8986)_
- Cleveland Clinic, Cleveland, Ohio, United States _(41.4995, -81.6954)_
- The Ohio State University Wexner Medical Center, Columbus, Ohio, United States _(39.9612, -82.9988)_
- Movement Disorder Clinic of Oklahoma PLLC, Tulsa, Oklahoma, United States _(36.1540, -95.9928)_
- Vanderbilt University Medical Center, Nashville, Tennessee, United States _(36.1659, -86.7844)_
- Central Texas Neurology Consultants, Round Rock, Texas, United States _(30.5083, -97.6789)_
- EvergreenHealth, Kirkland, Washington, United States _(47.6815, -122.2087)_

## Central Contacts

- Annie Blobaum, Ph.D. — (CONTACT) — 615-427-1935 — annie@appellopharma.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT07432958*  
*HTML version: https://parkinsonspathways.com/trial/NCT07432958*  
*Source data: https://clinicaltrials.gov/study/NCT07432958*