Accelerating Clinical Trials for Parkinsons Disease Using Multiple Treatments Including Telmisartan and Terazosin Compared to Placebo

What this Trial Is About

Parkinsons disease PD is a rapidly growing neurological condition that affects physical abilities and causes symptoms like difficulty with speech, swallowing, mood, thinking, and memory. Current treatments help with symptoms but lose effectiveness over time and may cause serious side effects. This trial uses a Multi-Arm, Multi-Stage MAMS design to test multiple treatments at once, comparing each to a placebo to assess safety and potential benefits. Promising treatments continue while ineffective ones are replaced, making the trial faster and more efficient. Participants will start in one of three groups standard care plus placebo, standard care plus telmisartan, or standard care plus terazosin. The trial begins with two treatment arms and one placebo arm, with a third treatment arm added after one year. Treatments involve daily capsules with a 5-week titration phase to reach target doses, followed by up to 36 months of treatment. New treatments may be added yearly based on interim safety and effectiveness reviews. After an initial in-person screening, follow-up visits occur remotely at 3 months, 6 months, and every 6 months thereafter, up to 36 months. These visits include questionnaires, symptom assessments using the Movement Disorder Society-Unified Parkinsons Disease Rating Scale, cognitive and mood tests, quality of life surveys, and safety monitoring. Participants will be kept informed of trial progress and results through the trial website and medical publications.

Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease: A Multiarm Multi-stage Platform Trial