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
Start Date
2/25/2026
Completion Date
1/3/2028
Summary
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.
Eligibility Criteria
Age Range: 30 years to 80 years
Interventions
AP-472
Placebo
Conditions
Locations
University of Arkansas for Medical Sciences (Site #208)
Little Rock, Arkansas 72205-5551
United States
Profound Research LLC (Site #222)
Carlsbad, California 92011
United States
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217)
Los Alamitos, California 90720-3108
United States
Keck Medicine of USC - USC Healthcare Center 2 (Site #221)
Los Angeles, California 90033-5310
United States
Parkinson's Research Centers of America (Site #218)
Palo Alto, California 94301
United States
Rocky Mountain Clinical Research - CenExel - PPDS (Site #215)
Englewood, Colorado 80113-2776
United States
Parkinson's Disease & Movement Disorders Center of Boca Raton (Site #227)
Boca Raton, Florida 33486
United States
UM-UHealth at Boca Raton (Site #226)
Boca Raton, Florida 33486
United States
Velocity Clinical Research - Hallandale Beach (Site #228)
Hallandale, Florida 33009
United States
University of Miami (Site #220)
Miami, Florida 33136-1051
United States
Neurology One (Site #205)
Orlando, Florida 32825
United States
USF Parkinson's Disease and Movement Disorders Center (Site #206)
Tampa, Florida 33613-4808
United States
Augusta University Medical Center (Site #212)
Augusta, Georgia 30912-0020
United States
Josephson Wallack Munshower Neurology PC (Site #231)
Indianapolis, Indiana 46256
United States
The University of Kansas (KU) (Site #216)
Kansas City, Kansas 66160
United States
Kentucky Neuroscience Institute (Site #213)
Lexington, Kentucky 40536-0001
United States
Beth Israel Deaconess Medical Center (Site #211)
Boston, Massachusetts 02215-5400
United States
University of Michigan Health System (UMHS) (Site #202)
Ann Arbor, Michigan 48109
United States
Quest Research Institute - Alcanza - PPDS (Site #201)
Farmington Hills, Michigan 48334-2973
United States
University of New Mexico Health Sciences Center (Site #225)
Albuquerque, New Mexico 87106
United States
Joan and Sanford I. Weill Department of Medicine (Site #224)
New York, New York 10021
United States
Mount Sinai School of Medicine (Site #209)
New York, New York 10029-6501
United States
Asheville Neurology Specialists, P.A. (Site #229)
Asheville, North Carolina 28806
United States
Duke Neurological Disorders Clinic (Site #210)
Durham, North Carolina 27705
United States
Cleveland Clinic (Site #223)
Cleveland, Ohio 44195-0001
United States
The Ohio State University Wexner Medical Center (site #207)
Columbus, Ohio 43210
United States
Vanderbilt University Medical Center (Site #204)
Nashville, Tennessee 37232
United States
Horizon Clinical Research: Gill Neuroscience - Houston (Site #232)
Cypress, Texas 77429
United States
Central Texas Neurology Consultants (Site #203)
Round Rock, Texas 78681-3578
United States
EvergreenHealth (Site #219)
Kirkland, Washington 98034-3013
United States