Reduce wearing off between doses
- Trial ID
- NCT07432958
- 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
- Goal
- Reduce wearing off between doses
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Appello Pharmaceuticals, Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 150 participants
- Conditions
- Parkinson Disease
- Interventions
- AP-472, Placebo
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.
Locations
- University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
- Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS, Los Alamitos, California, United States
- Keck Medicine of USC - USC Healthcare Center 2, Los Angeles, California, United States
- North County Neurology Associates, Oceanside, California, United States
- Parkinson's Research Centers of America, Palo Alto, California, United States
- Rocky Mountain Clinical Research - CenExel - PPDS, Englewood, Colorado, United States
- University of Miami, Miami, Florida, United States
- Neurology One, Orlando, Florida, United States
- USF Parkinson's Disease and Movement Disorders Center, Tampa, Florida, United States
- Augusta University Medical Center, Augusta, Georgia, United States
- The University of Kansas (KU), Kansas City, Kansas, United States
- Kentucky Neuroscience Institute, Lexington, Kentucky, United States
- Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
- University of Michigan Health System (UMHS), Ann Arbor, Michigan, United States
- Quest Research Institute - Alcanza - PPDS, Farmington Hills, Michigan, United States
- University of New Mexico Health Sciences Center, Albuquerque, New Mexico, United States
- Mount Sinai School of Medicine, New York, New York, United States
- Joan and Sanford I. Weill Department of Medicine, New York, New York, United States
- Duke Neurological Disorders Clinic, Durham, North Carolina, United States
- Cleveland Clinic, Cleveland, Ohio, United States
And 5 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying AP-472. 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.
- Who can participate?
- Participants must be between 30 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 25 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 1 year and 6 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.