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Tests treatment safety and results for Parkinson Disease
Official title 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
ClinicalTrials.gov ID: NCT07432958
What this study is testing
What is AP-472?
AP-472 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for parkinson disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80
You may be able to join if
- Key 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...
- 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...
You likely can't join if
- 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...
- 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...
- Are currently taking medications that block dopamine, except for low-dose quetiapine (up to 50 mg per day) used for insomnia.
See the full eligibility criteria
- Key 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Carlsbad, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Englewood, Colorado, United States
- Boca Raton, Florida, United States
- Hallandale, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Augusta, Georgia, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Farmington Hills, Michigan, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Carlsbad, California, United States; Los Alamitos, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Englewood, Colorado, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.