Parkinson’s Disease – Appello Pharmaceuticals APLO-1201

Participating in a clinical trial with Profound means making a real difference in the lives of others facing similar health challenges.

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.

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).

Complete the form to get connected with new research studies and our team will reach out soon to help determine your eligibility.