Ongoing Clinical Trials for Dementia with Lewy Bodies
Currently, 3 clinical trials are investigating new treatments for Dementia with Lewy Bodies, a progressive brain disorder caused by abnormal protein deposits that affect thinking, movement, and behavior. These studies are testing medications including ambroxol, neflamapimod, and advanced brain imaging techniques across Norway, Sweden, and France.
Clinical trial locations
- France
- Norway
- Sweden
Study of Ambroxol Treatment in People with Early Stage or Mild Lewy Body Dementia
This study is taking place in Norway and focuses on testing ambroxol, a medication traditionally used to help clear mucus from airways, for a new purpose: potentially slowing down the progression of Lewy body dementia. The research targets people in the early stages of the disease, including those with mild cognitive impairment related to this condition.
Who can participate: Men and women between 50 and 85 years old who have been diagnosed with Dementia with Lewy Bodies or mild cognitive impairment related to this condition are eligible. Participants must score 15 or higher on a memory test called the MMSE, be able to provide informed consent, and have a caregiver who can help monitor their condition at least three times per week. Women of childbearing age must use approved birth control methods. Participants need to be able to take oral medication and travel to the study location for appointments.
Who cannot participate: People with severe liver or kidney problems, uncontrolled high blood pressure, severe heart disease, or those who are pregnant or breastfeeding cannot join. The study also excludes individuals with known allergies to ambroxol, those with other types of dementia, people with severe psychiatric conditions, and those with a history of recent alcohol or drug abuse.
What the study involves: The study compares two groups of participants. One group receives ambroxol tablets while the other receives a placebo. The medication dosage starts low and gradually increases over four weeks, beginning at 60 mg three times daily and eventually reaching 420 mg three times daily. This final dosage continues for approximately 18 months. Throughout the study, participants undergo regular assessments of their thinking abilities, memory, movement, sleep patterns, and daily functioning. Blood samples are collected for genetic testing to understand how the medication works in people with different genetic characteristics.
Investigational drug: Ambroxol is being studied for its potential to protect brain cells and slow disease progression. Research suggests it may work by increasing the activity of an enzyme called glucocerebrosidase in the brain, which helps reduce the buildup of toxic proteins associated with the condition.
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 Swedish study focuses on improving the diagnosis of several brain disorders, including Dementia with Lewy Bodies, using advanced brain imaging techniques. The research aims to better identify people at risk of developing dementia by using special substances that help doctors see changes in the brain through PET scans.
Who can participate: People between 20 and 100 years old who are fluent in Swedish can participate. All participants must agree to undergo at least one lumbar puncture (a procedure to collect spinal fluid), an MRI brain scan, and neuropsychological testing. The study includes three groups: healthy elderly individuals with no cognitive symptoms and normal test performance; people with mild cognitive impairment who have symptoms but can still manage daily activities; and people with dementia whose symptoms meet diagnostic criteria.
Who cannot participate: The study excludes patients who already have confirmed diagnoses of Alzheimer’s disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration, or other neurodegenerative disorders involving tau protein buildup.
What the study involves: Participants receive injections of imaging substances called Vizamyl and [18F]RO6958948, which help visualize specific proteins in the brain during PET scans. These scans show patterns associated with neurodegenerative diseases. The study compares brain scan results with other diagnostic methods, including cerebrospinal fluid testing and MRI findings, to improve diagnostic accuracy. Participants may undergo follow-up assessments to monitor changes in cognitive function over time.
Investigational drugs: Tau PET ([18F]RO6958948) helps doctors see tau protein buildup in the brain, while Vizamyl (Flutemetamol 18F) detects amyloid plaques. Both types of protein accumulation are associated with dementia. These imaging tests provide detailed brain pictures that help assess the risk of developing dementia and aid in early detection.
Study on Neflamapimod for Patients with Dementia with Lewy Bodies
This clinical trial in France is testing a medication called neflamapimod, also known as VX-745, for its potential to help patients with Dementia with Lewy Bodies. The study aims to evaluate how safe and well-tolerated this medication is while monitoring its effects on cognitive and behavioral symptoms.
Who can participate: Men and women aged 55 years or older with a probable diagnosis of Dementia with Lewy Bodies can participate. Participants must score 18 or higher on a memory test called MoCA. If taking medications for memory and thinking (cholinesterase inhibitors or memantine), participants must have been on stable doses for at least 6 weeks. Those who previously took these medications must have stopped at least 3 months before starting the study. Participants need normal or corrected vision and hearing, no history of learning difficulties that could affect testing, and must have received COVID-19 vaccination unless medically unable. A reliable caregiver or informant must be available to provide information about the participant.
Who cannot participate: People without a confirmed diagnosis of Dementia with Lewy Bodies, those outside the specified age range, and individuals considered part of vulnerable populations requiring special protection cannot participate. Those who do not meet specific health criteria set by the study are also excluded.
What the study involves: Participants take neflamapimod capsules by mouth at a dosage of 80 mg twice daily for 24 weeks. Throughout this period, regular monitoring evaluates the medication’s safety and tolerability. Assessments include cognitive and functional tests such as the Montreal Cognitive Assessment and the Clinical Dementia Rating Sum of Boxes. At the end of the 24-week period, a final evaluation assesses changes in cognitive and behavioral measures and reviews any side effects experienced during the trial.
Investigational drug: Neflamapimod works by inhibiting an enzyme called P38 alpha kinase, which is believed to play a role in inflammation and brain cell damage associated with Dementia with Lewy Bodies. The medication is being studied for its potential to improve cognitive function and reduce symptoms in patients with this condition.
Summary
The three ongoing clinical trials for Dementia with Lewy Bodies reflect diverse approaches to understanding and treating this complex condition. Geographically, research is distributed across three European countries: Norway, Sweden, and France, each hosting one trial.
Two trials focus on testing specific medications with different mechanisms of action. The Norwegian study investigates ambroxol, a medication with an established safety profile from its traditional use in respiratory conditions, now being repurposed to potentially protect brain cells and slow disease progression over an 18-month period. The French trial examines neflamapimod, a kinase inhibitor designed to reduce inflammation and brain cell damage, with a shorter 24-week assessment period.
The Swedish study takes a different approach by focusing on improving diagnostic accuracy rather than treatment. This research uses advanced brain imaging techniques to better identify people at risk of developing dementia, which could lead to earlier intervention and improved patient outcomes.
All three studies require participants to have caregivers or informants available, reflecting the practical challenges of managing this condition and the importance of support systems in both research and daily care. The varying eligibility criteria, from early-stage disease in the Norwegian trial to confirmed diagnoses in the French study, suggest these trials collectively address different points in the disease journey.
