RESEARCH / PARTICIPATIONBack to the library
← Find a study
Recruiting · registry status

Testing an add-on medicine when movement symptoms vary

Researchers compare two doses of the study medicine AP-472 with a look-alike inactive treatment in people whose movement symptoms fluctuate while taking levodopa.

Testing a treatment or activity · Study reference: NCT07432958

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

Who can join?

Ages 30 years to 80 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.
Full study name & original research details

Official study 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

Short title used by the registry

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

Original description

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.

Conditions reported: Parkinson Disease

Study type
Interventional
Interventions
AP-472; Placebo
Phases
PHASE2
Sponsor
Appello Pharmaceuticals, Inc.
Start date reported by registry
2026-02-25 (actual)

Registry updated: 2026-10-06 · Status last verified by the registry submitter: 2026-10

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Annie Blobaum, Ph.D. · 615-427-1935 · annie@appellopharma.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University of Arkansas for Medical Sciences (Site #208)

Little Rock, Arkansas, United States

Recruiting

Profound Research LLC (Site #222)

Carlsbad, California, United States

Recruiting

Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217)

Los Alamitos, California, United States

Recruiting

Keck Medicine of USC - USC Healthcare Center 2 (Site #221)

Los Angeles, California, United States

Recruiting

Parkinson's Research Centers of America (Site #218)

Palo Alto, California, United States

Recruiting

Rocky Mountain Clinical Research - CenExel - PPDS (Site #215)

Englewood, Colorado, United States

Recruiting

Parkinson's Disease & Movement Disorders Center of Boca Raton (Site #227)

Boca Raton, Florida, United States

Recruiting

UM-UHealth at Boca Raton (Site #226)

Boca Raton, Florida, United States

Recruiting

Velocity Clinical Research - Hallandale Beach (Site #228)

Hallandale, Florida, United States

Recruiting

University of Miami (Site #220)

Miami, Florida, United States

Recruiting

Neurology One (Site #205)

Orlando, Florida, United States

Recruiting

USF Parkinson's Disease and Movement Disorders Center (Site #206)

Tampa, Florida, United States

Recruiting

Augusta University Medical Center (Site #212)

Augusta, Georgia, United States

Recruiting

Josephson Wallack Munshower Neurology PC (Site #231)

Indianapolis, Indiana, United States

Recruiting

The University of Kansas (KU) (Site #216)

Kansas City, Kansas, United States

Recruiting

Kentucky Neuroscience Institute (Site #213)

Lexington, Kentucky, United States

Recruiting

Beth Israel Deaconess Medical Center (Site #211)

Boston, Massachusetts, United States

Recruiting

University of Michigan Health System (UMHS) (Site #202)

Ann Arbor, Michigan, United States

Recruiting

Quest Research Institute - Alcanza - PPDS (Site #201)

Farmington Hills, Michigan, United States

Recruiting

University of New Mexico Health Sciences Center (Site #225)

Albuquerque, New Mexico, United States

Recruiting

Joan and Sanford I. Weill Department of Medicine (Site #224)

New York, New York, United States

Recruiting

Mount Sinai School of Medicine (Site #209)

New York, New York, United States

Recruiting

Asheville Neurology Specialists, P.A. (Site #229)

Asheville, North Carolina, United States

Recruiting

Duke Neurological Disorders Clinic (Site #210)

Durham, North Carolina, United States

Recruiting

Cleveland Clinic (Site #223)

Cleveland, Ohio, United States

Recruiting

The Ohio State University Wexner Medical Center (site #207)

Columbus, Ohio, United States

Recruiting

Vanderbilt University Medical Center (Site #204)

Nashville, Tennessee, United States

Recruiting

Horizon Clinical Research: Gill Neuroscience - Houston (Site #232)

Cypress, Texas, United States

Recruiting

Central Texas Neurology Consultants (Site #203)

Round Rock, Texas, United States

Recruiting

EvergreenHealth (Site #219)

Kirkland, Washington, United States

Recruiting

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.