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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

Appello Pharmaceuticals, Inc. · NCT07432958

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 30–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
150
US sites recruiting
30
Study start
February 25, 2026
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: AP-472; Placebo

Conditions: Parkinson Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

Participants must meet all of the following criteria to take part in the study:

  • Be a man or woman between 30 and 80 years of age at the time of screening.
  • 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.
  • 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).
  • 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.
  • Have a Montreal Cognitive Assessment (MoCA) score of 24 or higher at screening.
  • Be able to walk independently, with or without the use of a walking aid.
  • Be able to swallow oral medication.
  • 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.
  • 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:

  • Have a form of parkinsonism that is not typical Parkinson's disease, such as secondary or atypical parkinsonism.
  • 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.
  • Have dyskinesias (involuntary movements) that are severe enough, in the study doctor's opinion, to interfere with participation.
  • Have a history of only certain types of dyskinesias (such as OFF-state, diphasic, myoclonic, or dystonic dyskinesias) without typical peak-dose dyskinesias.
  • Are currently taking medications that block dopamine, except for low-dose quetiapine (up to 50 mg per day) used for insomnia.
  • Routinely use on-demand "rescue" Parkinson's medications more than three times per week.

Recruiting US locations

  • University of Arkansas for Medical Sciences (Site #208)

    Little Rock, AR 72205-5551

  • Profound Research LLC (Site #222)

    Carlsbad, CA 92011

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

    Los Alamitos, CA 90720-3108

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

    Los Angeles, CA 90033-5310

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

    Palo Alto, CA 94301

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

    Englewood, CO 80113-2776

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

    Boca Raton, FL 33486

  • UM-UHealth at Boca Raton (Site #226)

    Boca Raton, FL 33486

  • Velocity Clinical Research - Hallandale Beach (Site #228)

    Hallandale, FL 33009

  • University of Miami (Site #220)

    Miami, FL 33136-1051

  • Neurology One (Site #205)

    Orlando, FL 32825

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

    Tampa, FL 33613-4808

  • Augusta University Medical Center (Site #212)

    Augusta, GA 30912-0020

  • Josephson Wallack Munshower Neurology PC (Site #231)

    Indianapolis, IN 46256

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

    Kansas City, KS 66160

  • Kentucky Neuroscience Institute (Site #213)

    Lexington, KY 40536-0001

  • Beth Israel Deaconess Medical Center (Site #211)

    Boston, MA 02215-5400

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

    Ann Arbor, MI 48109

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

    Farmington Hills, MI 48334-2973

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

    Albuquerque, NM 87106

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

    New York, NY 10021

  • Mount Sinai School of Medicine (Site #209)

    New York, NY 10029-6501

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

    Asheville, NC 28806

  • Duke Neurological Disorders Clinic (Site #210)

    Durham, NC 27705

  • Cleveland Clinic (Site #223)

    Cleveland, OH 44195-0001

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

    Columbus, OH 43210

  • Vanderbilt University Medical Center (Site #204)

    Nashville, TN 37232

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

    Cypress, TX 77429

  • Central Texas Neurology Consultants (Site #203)

    Round Rock, TX 78681-3578

  • EvergreenHealth (Site #219)

    Kirkland, WA 98034-3013

Study contacts (from the official record)

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