Ongoing Clinical Trials for Progressive Supranuclear Palsy
Progressive supranuclear palsy is a rare brain disorder affecting movement, balance, and eye control. Currently, 6 clinical trials are investigating new diagnostic tools and potential treatments to slow disease progression, including imaging agents to detect brain protein deposits and experimental medications aimed at protecting nerve cells and managing symptoms.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- France
- Germany
- Study of FNP-223 tablets to slow disease progression in patients with Progressive Supranuclear Palsy (PSP)
- Study on the Effects of AMX0035 (Phenylbutyrate and Ursodoxicoltaurine) in Patients with Progressive Supranuclear Palsy
- Study on the Long-Term Safety of Bepranemab for Adults with Progressive Supranuclear Palsy
- Hungary
- Italy
- Netherlands
- Poland
- Portugal
- Spain
- Study on the Use of 18F-PI-2620 for Patients with Progressive Supranuclear Palsy and Parkinson’s Disease
- Study of FNP-223 tablets to slow disease progression in patients with Progressive Supranuclear Palsy (PSP)
- Study on Brain Imaging with [18F]PI-2620 for Progressive Supranuclear Palsy Patients
- Study on the Effects of AMX0035 (Phenylbutyrate and Ursodoxicoltaurine) in Patients with Progressive Supranuclear Palsy
- Study on the Long-Term Safety of Bepranemab for Adults with Progressive Supranuclear Palsy
- Sweden
Study on the Accuracy of Tau PET ([18F]RO6958948) and Vizamyl (Flutemetamol 18F) in Diagnosing Mild Cognitive Symptoms and Risk of Alzheimer’s Disease
This study in Sweden focuses on improving the diagnosis of neurodegenerative disorders, including progressive supranuclear palsy. It uses two special imaging substances to help doctors see changes in the brain through PET scans.
Who can participate: Adults aged 20 to 100 who speak Swedish fluently and agree to undergo lumbar puncture, brain MRI, and cognitive testing. Participants may be healthy elderly individuals with no symptoms, those with mild cognitive impairment, or those already diagnosed with dementia. All participants must have preserved general thinking and daily functioning appropriate to their cognitive status.
Who cannot participate: Patients with other neurodegenerative disorders involving tau protein buildup, including those with Alzheimer’s disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration, or mild cognitive impairment who are not at high risk of developing dementia.
Study focus: The trial aims to determine how well two imaging agents, Vizamyl and [18F]RO6958948, can help identify people at risk of developing dementia. Participants undergo brain scans and cognitive tests to monitor brain health over time. The study compares brain scans of people with these disorders to healthy individuals to better understand disease differences and improve early detection.
Investigational drugs: Tau PET (18F-RO6958948) and Vizamyl (18F-Flutemetamol) are imaging agents used to detect tau protein and amyloid plaques in the brain, respectively. These substances help doctors assess dementia risk through specialized brain scans.
Study on the Use of 18F-PI-2620 for Patients with Progressive Supranuclear Palsy and Parkinson’s Disease
This Spanish study examines how an imaging agent called [18F]PI-2620 can help visualize certain brain proteins in patients with progressive supranuclear palsy and Parkinson’s disease using PET scans.
Who can participate: Adults aged 40 to 80 who can comply with study procedures and provide informed consent. Participants should have a diagnosis of progressive supranuclear palsy, Parkinson’s disease, or be healthy controls without neurological conditions. All participants must have undergone brain MRI to rule out other conditions. Women must be postmenopausal or have negative pregnancy tests, and all participants of childbearing age must use effective contraception.
Who cannot participate: The study does not list specific exclusion criteria beyond general health requirements.
Study focus: The trial analyzes how [18F]PI-2620 is taken up in different brain regions in people with these conditions compared to healthy individuals. Researchers examine how these differences relate to factors like age, clinical symptoms, and biological markers. The study runs until late 2026 and aims to provide insights that could lead to better understanding and treatment of these neurological conditions.
Investigational drug: 18F-PI-2620 is an imaging agent that helps visualize tau proteins in the brain through PET scans, aiding in the diagnosis and understanding of progressive supranuclear palsy and similar conditions.
Study of FNP-223 tablets to slow disease progression in patients with Progressive Supranuclear Palsy (PSP)
This multi-country study across Portugal, Germany, Poland, France, Spain, Italy, and Hungary evaluates whether FNP-223 can slow the progression of symptoms over 52 weeks.
Who can participate: Adults aged 50 to 80 weighing between 43 kg and 120 kg who have had symptoms for 3 years or less. Participants must score 40 or less on the PSP Rating Scale, walk at least 10 steps (possibly with a cane), and score 23 or higher on cognitive testing (MoCA). A caregiver who spends at least 7 hours weekly with the patient must attend study visits. Participants must have specific eye movement or balance problems and cannot live in nursing homes or dementia care facilities.
Who cannot participate: People under 40 or over 80, those with other neurological disorders, recent heart problems, severe liver or kidney dysfunction, uncontrolled high blood pressure, active cancer, history of stroke, pregnant or breastfeeding women, those unable to provide consent or attend visits, people taking interfering medications, severe psychiatric conditions, recent alcohol or drug abuse, or planned major surgery during the study.
Study focus: The study compares FNP-223 with placebo to assess effectiveness and safety. Participants are monitored for changes in movement ability, daily activities, thinking skills, and quality of life. Regular check-ups track any side effects and evaluate treatment effectiveness.
Investigational drug: FNP-223 is an experimental oral medication taken as film-coated tablets, being tested for its potential to slow disease progression and help patients maintain physical abilities and daily functions longer.
Study on Brain Imaging with [18F]PI-2620 for Progressive Supranuclear Palsy Patients
This Spanish study uses PET scan imaging with [18F]PI-2620 to compare tau 4R protein levels in the brains of people with progressive supranuclear palsy to those without neurodegenerative conditions.
Who can participate: Adults aged 40 to 79 who have been diagnosed with progressive supranuclear palsy, or are part of a control group including Parkinson’s disease patients or healthy individuals with normal cognitive function (MoCA score above 24). Participants or their representatives must provide consent and be able to meet all study requirements.
Who cannot participate: People with other serious medical conditions that might interfere with the study, those unable to undergo PET-Tau imaging, current participants in other trials, those with severe allergic reactions to study substances, pregnant or breastfeeding women, recent history of drug or alcohol abuse, or anyone deemed unsuitable by the study doctor.
Study focus: Participants receive an injection of [18F]PI-2620 and undergo PET scans to visualize tau protein deposits in the brain. The study also assesses glucose metabolism patterns and monitors movement and non-motor symptoms. The research continues until December 2026 and aims to better understand how the disease affects the brain.
Investigational drug: 18F-PI2620 is a radiotracer used in PET scans to help visualize and measure tau protein deposits in the brain, assisting in diagnosis and disease monitoring.
Study on the Effects of AMX0035 (Phenylbutyrate and Ursodoxicoltaurine) in Patients with Progressive Supranuclear Palsy
This large study across Poland, Germany, Bulgaria, Sweden, France, Netherlands, Spain, Italy, Belgium, and Austria tests whether AMX0035 can slow disease progression compared to placebo.
Who can participate: Adults aged 40 to 80 who score 24 or higher on mental ability testing and less than 40 on the PSP Rating Scale. Participants must have had symptoms for less than 5 years and be able to walk 5 steps with minimal support. They need a study partner (caregiver or family member) to attend visits and provide information. Women must have negative pregnancy tests and all participants of childbearing age must use effective contraception during the study and for 6 months afterward. Participants must be willing to attend visits, follow treatment plans, and complete tests including MRI scans, and cannot live in skilled nursing or dementia care facilities.
Who cannot participate: People with other serious medical conditions, inability to follow study procedures, severe allergic reactions to study medications, pregnancy or breastfeeding, participation in other trials, significant mental health conditions, history of drug or alcohol abuse, other brain conditions, recent or planned major surgery, or conditions affecting the immune system.
Study focus: The trial monitors disease progression over time using the Progressive Supranuclear Palsy Rating Scale at Week 52 as the primary measure. Participants take AMX0035 orally in powder form and undergo regular visits including MRI scans, laboratory tests, and symptom assessments to track changes and side effects.
Investigational drug: AMX0035 contains phenylbutyrate and ursodoxicoltaurine, taken orally as tablets. It works as a neuroprotective agent, protecting nerve cells from damage to potentially preserve brain function and slow disease progression.
Study on the Long-Term Safety of Bepranemab for Adults with Progressive Supranuclear Palsy
This open-label extension study in Germany, Belgium, and Spain evaluates the long-term safety and tolerability of Bepranemab, given as an intravenous infusion.
Who can participate: Adults with Richardson’s Syndrome (a form of progressive supranuclear palsy) who completed treatment in a previous study called PSP003. Male participants must use birth control and not donate sperm during treatment and for 6 months after the last dose. Female participants must not be pregnant or breastfeeding, and must either be unable to have children or use birth control during treatment and for 6 months afterward. Participants or their legal representatives must be able to provide informed consent and follow study requirements.
Who cannot participate: People with other serious medical conditions, current participation in other trials, recent or planned major surgery, history of severe allergic reactions to medications, pregnancy or breastfeeding, history of drug or alcohol abuse, inability to comply with study procedures or follow-up visits, or any condition making them unsuitable according to the study doctor.
Study focus: This extension study monitors participants who received Bepranemab in a previous trial to assess long-term safety and tolerance of the treatment. All participants receive the actual treatment rather than placebo, and health monitoring continues until 2027 to collect comprehensive data on adverse events and long-term effects.
Investigational drug: Bepranemab (also called UCB0107) is a monoclonal antibody given through intravenous infusion. It is designed to target and modify specific proteins involved in the disease process, potentially slowing progression of progressive supranuclear palsy.
Summary
Six clinical trials are currently investigating progressive supranuclear palsy across multiple European countries. Spain leads with five trials, followed by Germany with four trials, demonstrating significant research concentration in these regions. The studies fall into two main categories: diagnostic imaging studies and treatment trials.
Three trials focus on diagnostic imaging using PET scan technology with different agents (18F-RO6958948, 18F-PI-2620, and Vizamyl) to detect protein deposits in the brain that are characteristic of the disease. These imaging studies aim to improve early diagnosis and understanding of disease progression.
Three trials test potential treatments: FNP-223 tablets, AMX0035 (a combination of phenylbutyrate and ursodoxicoltaurine), and Bepranemab infusions. These treatment studies aim to slow disease progression and preserve patient function over time. The AMX0035 study is the largest, spanning 10 countries across Europe.
Most trials require participants to be middle-aged or older adults with confirmed diagnoses, adequate cognitive function, and the ability to walk with minimal assistance. A common requirement across treatment studies is the presence of a caregiver or study partner who can attend visits and provide information about the patient’s condition. The focus on both diagnostic tools and therapeutic interventions reflects a comprehensive approach to addressing this challenging neurological condition.
