Clinical Trials for Neurodegenerative Disorders
There are currently 5 ongoing clinical trials focused on neurodegenerative disorders. These trials are investigating various approaches to diagnosis, treatment, and monitoring of conditions such as Alzheimer’s Disease, Parkinson’s Disease, and other related brain disorders. The studies involve innovative imaging techniques, new medications, and research into how these conditions can be detected and managed more effectively.
Clinical trial locations
- Belgium
- Finland
- France
- Germany
- Italy
- Netherlands
- Portugal
- Sweden
- Study of Latozinemab for Patients with Neurodegenerative Diseases Who Previously Participated in a Latozinemab Study
- Study on Neurodegenerative Diseases Using [18F]RO6958948 for Early Detection and Mapping in At-Risk Patients
- Study on the Accuracy of Tau PET ([18F]RO6958948) and Vizamyl (Flutemetamol 18F) in Diagnosing Mild Cognitive Symptoms and Risk of Alzheimer’s Disease
Study of Latozinemab for Patients with Neurodegenerative Diseases Who Previously Participated in a Latozinemab Study
This trial is designed to provide continued access to latozinemab for patients who have previously participated in a study involving this medication. Latozinemab is a monoclonal antibody that targets specific proteins involved in the progression of conditions such as Alzheimer’s Disease and Parkinson’s Disease.
Inclusion criteria: To participate, you must have successfully completed a previous trial involving latozinemab. At the initial visit, women must confirm they are not pregnant or breastfeeding, and those of childbearing age must agree to use highly effective contraception until 10 weeks after the last dose. Men must also agree to use contraception and not donate sperm during this period. All participants must be willing to follow the study requirements and agree not to donate blood for one year after the final dose.
Exclusion criteria: You cannot participate if you have not been in a previous latozinemab study or if you do not have a diagnosed neurodegenerative condition.
Focus: The study monitors the safety and effects of latozinemab administered intravenously over a maximum treatment period of 39 weeks. Participants will be assessed every three months using specific scales to evaluate disease severity and any changes in their condition. The trial will track adverse events and the development of antibodies against the medication.
Investigational drug: Latozinemab, administered as an intravenous infusion.
Study on Neurodegenerative Diseases Using [18F]RO6958948 for Early Detection and Mapping in At-Risk Patients
This trial uses an advanced brain imaging technique called tau PET to identify early signs of conditions such as Alzheimer’s Disease. The imaging agent, [18F]RO6958948, also known as RO948 (18F), helps visualize tau proteins that can build up in the brain and are linked to these diseases.
Inclusion criteria: Participants must be at least 18 years old and fluent in Swedish. You must be enrolled in specific ongoing studies, including H75, H70 Clinical Study, Epilepsy Study, BioMin Study, or SWEDOWN study. Women of childbearing age must agree to use highly effective contraception for 90 days after each treatment, and men with female partners must use condoms unless their partner is using effective birth control.
Exclusion criteria: You cannot participate if you already have a diagnosed neurodegenerative disease, are outside the specified age range, or belong to certain vulnerable groups requiring special protection.
Focus: The study aims to explore early detection methods and understand how tau protein accumulates in at-risk individuals. Participants will receive injections of RO948 (18F) and undergo PET imaging to map tau distribution in the brain. Additional tests may measure proteins in blood and cerebrospinal fluid.
Investigational drug: [18F]RO6958948 (RO948), administered as an injection for PET imaging.
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 evaluates two different imaging agents, Tau PET ([18F]RO6958948) and Vizamyl (Flutemetamol 18F), to improve the diagnosis of Alzheimer’s Disease and related conditions. These imaging tests help doctors see protein buildups in the brain that may indicate disease risk.
Inclusion criteria: Participants must be between 20 and 100 years old and fluent in Swedish. You must agree to undergo at least one lumbar puncture, a brain MRI scan, and neuropsychological testing. For healthy elderly participants, normal cognitive function is required. For those with mild cognitive impairment, cognitive symptoms should be present but not severe enough to warrant a dementia diagnosis. For participants with dementia, symptoms must meet diagnostic criteria at the study start.
Exclusion criteria: You cannot participate if you have other neurodegenerative disorders involving tau pathology, including conditions such as progressive supranuclear palsy, frontotemporal dementia, or corticobasal degeneration, or if you are not at high risk for developing dementia.
Focus: The trial compares brain imaging results from both agents with other diagnostic methods such as cerebrospinal fluid biomarkers and MRI findings. The goal is to enhance diagnostic accuracy and understand disease progression in individuals with varying levels of cognitive impairment.
Investigational drugs: Tau PET ([18F]RO6958948) and Vizamyl (Flutemetamol 18F), both administered as injections for PET imaging.
Study on the Effects of Dexmedetomidine on Brain Fluid Flow and Activity in Patients with Neurodegenerative Diseases, Delirium, or Acute Neurological Conditions
This trial investigates how dexmedetomidine, a sedative medication, affects brain functions such as blood flow and cerebrospinal fluid movement. The study uses functional MRI and electroencephalography (EEG) to observe these effects in patients under different levels of sedation.
Inclusion criteria: You must be fluent in Finnish, right-handed, and between 18 and 45 years old. Your head circumference must not exceed 59 cm. You must be in good health with normal ECG, blood pressure, and oxygen levels. There should be no signs of substance abuse, and laboratory test results must be within acceptable ranges. Your BMI must be between 18.5 and 30 kg/m².
Exclusion criteria: You cannot participate if you have a neurodegenerative disease, are experiencing delirium, or have an acute neurological condition.
Focus: The study examines how dexmedetomidine influences brain activity, blood flow, and cerebrospinal fluid dynamics while participants are awake and sedated. Researchers will monitor vital signs such as blood pressure and heart rate, and measure various biomarkers to understand the medication’s effects on brain health.
Investigational drug: Dexmedetomidine, administered intravenously.
Study on Donanemab Dosing for Adults with Early Alzheimer’s Disease
This trial studies different dosing strategies for donanemab, a medication designed to remove amyloid plaques from the brain. Amyloid plaques are protein deposits associated with Alzheimer’s Disease. The study aims to determine the most effective dosing method while minimizing side effects such as brain swelling.
Inclusion criteria: Participants must have experienced gradual and progressive memory changes for at least six months, reported by themselves or someone who knows them well. You must meet specific criteria based on brain scans using 18F flortaucipir PET and 18F florbetapir PET as determined by a central review. The study is open to all genders and includes individuals who may be considered part of vulnerable populations.
Exclusion criteria: You cannot participate if you have another serious medical condition that could interfere with the study, have had recent major surgery, are in another clinical trial, have a history of severe allergic reactions to medications, are pregnant or breastfeeding, have a history of drug or alcohol abuse, have been diagnosed with a different type of dementia, have uncontrolled high blood pressure, severe liver or kidney disease, or have had a stroke or heart attack in the past six months.
Focus: The study evaluates how different dosing regimens of donanemab affect the occurrence of ARIA-E (Amyloid-Related Imaging Abnormality-Edema/Effusion), a specific brain change that can be seen in brain scans. Participants will receive either donanemab or a placebo and will be monitored through regular brain scans and assessments over several months.
Investigational drug: Donanemab, administered as an intravenous infusion. The trial also uses Neuraceq, which contains Florbetaben (18F), for brain imaging purposes.
Summary
The five ongoing clinical trials for neurodegenerative disorders represent diverse approaches to understanding, diagnosing, and treating these conditions. A notable concentration of studies is taking place in Sweden, which hosts three of the five trials, including two advanced imaging studies focused on early detection of Alzheimer’s Disease. The latozinemab study spans the widest geographic area, including seven European countries.
Imaging technologies feature prominently across multiple trials, with tau PET and amyloid PET scans being used to visualize protein buildups in the brain before symptoms become severe. The medications being investigated include latozinemab and donanemab, both monoclonal antibodies targeting specific proteins, as well as dexmedetomidine for understanding brain function under sedation. These trials reflect the field’s emphasis on early detection, personalized treatment approaches, and continued access to promising therapies for patients already enrolled in previous studies.
