Clinical Trials for Dementia: Current Research and Treatment Options
There are currently 7 ongoing clinical trials studying various approaches to diagnosing and treating dementia, including Alzheimer’s disease, dementia with Lewy bodies, and autoimmune dementia. These trials are testing new imaging techniques, medications, and treatment strategies across several European countries including Sweden, Germany, the Netherlands, and Italy.
Clinical trial locations
- Germany
- Italy
- Netherlands
- Study on Neflamapimod for Treating Dementia with Lewy Bodies in Patients Aged 55 and Older
- Study on the Use of Flortaucipir for Diagnosing Mild Cognitive Impairment and Dementia in Patients
- Title: Evaluation of lorazepam, pregabalin, and olanzapine in treating agitated behavior in dementia patients who did not respond to standard treatments
- 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 Swedish study focuses on improving the diagnosis of neurodegenerative disorders, particularly Alzheimer’s disease, through advanced brain imaging techniques.
Main inclusion criteria: Participants must be between 20 and 100 years old and fluent in Swedish. They must agree to undergo at least one lumbar puncture, an MRI scan of the brain, 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 show cognitive symptoms but maintain daily functioning, and individuals with cognitive symptoms severe enough to meet dementia criteria.
Main exclusion criteria: Patients with neurodegenerative disorders involving tau-pathology, including progressive supranuclear palsy, frontotemporal dementia, or corticobasal degeneration, cannot participate. Those not at high risk of developing dementia due to Alzheimer’s disease or similar disorders are also excluded.
Study focus: The trial uses two specialized brain imaging substances: Tau PET (18F-RO6958948) and Vizamyl (Flutemetamol 18F). These imaging tests help doctors identify specific protein buildups in the brain that are associated with Alzheimer’s disease. The Tau PET scan detects tau protein accumulation, while Vizamyl helps visualize amyloid plaques. By comparing brain scans of people with these disorders to healthy individuals, researchers aim to understand differences and improve early detection methods.
Investigational drugs: The study uses two imaging agents rather than traditional medications. Tau PET (18F-RO6958948) is used to visualize tau protein deposits in the brain, while Vizamyl (18F-Flutemetamol) detects amyloid plaques. Both substances are administered as injections and help doctors assess the risk of developing dementia through special brain scans.
Study on the Benefits of Amyloid PET Imaging with Florbetaben (18F) and Flutemetamol (18F) for Patients with Various Types of Dementia
This German study examines whether amyloid PET imaging can improve diagnosis and management for people with various forms of dementia.
Main inclusion criteria: Participants must be at least 50 years old with valid German health insurance. They need someone who can provide information about them, such as a family member or friend. Candidates must have mild to moderate dementia with specific scores on assessment scales: a Clinical Dementia Rating Scale score greater than 0.5 and less than 3.0, and a Mini-Mental-Status Test score greater than 10. The diagnosis of dementia or Alzheimer’s disease must be unclear with less than 85% certainty, and candidates should not be able to have a cerebrospinal fluid test for medical reasons, personal refusal, or unclear results.
Main exclusion criteria: The study excludes patients with any diagnosed type of dementia, including Parkinson’s disease with dementia, all types of Alzheimer’s disease, vascular dementia, HIV-related dementia, Pick’s disease, Huntington’s disease, or Creutzfeldt-Jakob disease with dementia.
Study focus: Researchers compare the benefits of using amyloid PET imaging versus standard diagnostic procedures. Participants are randomly assigned to receive either the imaging or standard care. Follow-up assessments occur at 26, 52, 78, and 104 weeks to measure cognitive performance, quality of life, and care needs. The study aims to determine if this specialized brain imaging can provide clearer diagnoses and improve treatment planning.
Investigational drugs: The study uses amyloid PET imaging agents, either Neuraceq (Florbetaben 18F) or VIZAMYL (Flutemetamol 18F), administered through intravenous injection to help detect amyloid plaques associated with Alzheimer’s disease.
Study on the Use of Flortaucipir for Diagnosing Mild Cognitive Impairment and Dementia in Patients
This Dutch study evaluates whether tau PET imaging using Flortaucipir can improve diagnostic accuracy for mild cognitive impairment and dementia.
Main inclusion criteria: Patients must be 50 years or older, in either the prodromal stage (mild cognitive impairment) or mild dementia stage with a Clinical Dementia Rating score of 1. They must have completed routine assessments including cognitive tests and an MRI scan. There should be substantial diagnostic uncertainty (less than 85% certainty) after routine screening, with Alzheimer’s disease considered as a possible diagnosis. Participants must be able to tolerate study procedures and make an informed decision to participate.
Main exclusion criteria: People with serious medical conditions that could interfere with the study, inability to undergo a PET scan, current participation in another clinical trial, significant head injury in the past year, history of drug or alcohol abuse in the past year, pregnancy or breastfeeding, known allergies to study substances, or mental health conditions that could interfere with participation are excluded.
Study focus: The trial assesses how tau PET imaging affects diagnosis accuracy, physician confidence, and patient management. Researchers compare tau PET results with other diagnostic methods, including new blood tests and artificial intelligence tools. The study evaluates impacts on patient wellbeing, including anxiety and uncertainty levels, to determine if tau PET offers a more reliable diagnostic approach.
Investigational drugs: The study uses Flortaucipir (LY3191748), a tau PET imaging agent administered through injection to help visualize tau protein deposits in the brain.
Evaluation of lorazepam, pregabalin, and olanzapine in treating agitated behavior in dementia patients who did not respond to standard treatments
This Dutch trial focuses on managing agitated behavior in nursing home residents with dementia who have not responded to standard treatments.
Main inclusion criteria: Participants must be nursing home residents with diagnosed dementia showing signs of agitated behavior such as restlessness, aggression, or increased activity. The treating physician must have already decided to prescribe quetiapine, olanzapine, or lorazepam based on clinical need, independently of the research study. Participants must be adults aged 18 or older and able to provide consent themselves or through a legal representative.
Main exclusion criteria: People with severe allergic reactions to psychiatric medications, other serious mental health conditions besides dementia, severe liver or kidney problems, current participation in other trials, inability to comply with study procedures, use of interacting medications, uncontrolled high blood pressure, severe heart conditions, substance abuse within six months, severe neurological conditions other than dementia, pregnancy or breastfeeding, terminal illness with life expectancy less than 12 months, severe communication difficulties, or blood disorders cannot participate.
Study focus: The study compares three psychotropic medications over a 6-week treatment period, with maximum daily doses of 50mg quetiapine, 10mg olanzapine, or 2mg lorazepam. Researchers monitor changes in agitated behavior using assessment tools including the Cohen Mansfield Agitation Inventory and Clinical Global Impression scales. All medications are provided in identical capsules to ensure neither patients nor healthcare providers know which treatment is being given.
Investigational drugs: The trial tests three psychotropic medications that affect brain function: quetiapine, olanzapine, and lorazepam. These medications are being evaluated for their effectiveness in managing agitation when standard recommended treatments have not worked.
Study on Efgartigimod for Patients with Autoimmune Dementia
This German study tests a new treatment for autoimmune dementia, a condition where the immune system mistakenly attacks healthy brain cells.
Main inclusion criteria: Participants must be 40 years or older with an expert diagnosis of progressive cognitive impairment or dementia lasting more than 3 months. They must score between 10 and 25 on the MoCA test, which checks memory and thinking skills. The presence of anti-brain autoantibodies in blood or spinal fluid is required. Candidates must speak German well enough to understand study information and complete cognitive tests, provide written consent, be able to attend study visits, and have received recommended vaccinations including COVID-19 vaccination.
Main exclusion criteria: People with other autoimmune diseases affecting the brain, serious infections in the past month, current treatment with experimental drugs, history of severe allergic reactions to medications, pregnancy or breastfeeding, substance abuse in the past year, or other serious medical conditions that might interfere with the study cannot participate.
Study focus: The 52-week trial evaluates whether Efgartigimod can improve cognitive function in autoimmune dementia patients. Participants receive either Efgartigimod or placebo through subcutaneous injection at a dose of 1,000 mg. Regular assessments at weeks 13, 27, and 53 monitor cognitive abilities, quality of life, and changes in blood and cerebrospinal fluid markers to understand how the treatment works.
Investigational drugs: Efgartigimod works by blocking a protein called FcRn that is involved in the immune system. By blocking this protein, Efgartigimod aims to reduce the harmful immune response that contributes to autoimmune dementia symptoms. It is administered through intravenous infusion directly into the bloodstream.
Study on Donanemab Dosing for Adults with Early Alzheimer’s Disease
This Italian trial examines different dosing strategies for Donanemab in adults with early Alzheimer’s disease to find the most effective and safe approach.
Main inclusion criteria: Participants must have a gradual and progressive change in memory function reported by themselves or someone who knows them well for at least 6 months. They must meet criteria for specific PET scans (18F flortaucipir and 18F florbetapir) as determined by central review. The study is open to any gender and includes individuals who may be considered part of a vulnerable population.
Main exclusion criteria: People with other serious medical conditions that might interfere with the study, recent major surgery or planned surgery during the study period, current participation in another clinical trial, history of severe allergic reactions to medications, pregnancy or breastfeeding, history of drug or alcohol abuse, diagnosis of a different type of dementia other than Alzheimer’s disease, uncontrolled high blood pressure, severe liver or kidney disease, or stroke or heart attack in the past six months cannot participate.
Study focus: The study compares different dosing regimens of Donanemab to understand their impact on ARIA-E (Amyloid-Related Imaging Abnormality-Edema/Effusion), a brain change sometimes seen in people receiving certain Alzheimer’s treatments. Researchers use brain imaging with Florbetaben (18F) to visualize brain changes and monitor participants closely throughout the study period to assess safety and effectiveness in reducing amyloid plaques.
Investigational drugs: Donanemab is a monoclonal antibody administered through intravenous infusion. It targets and removes amyloid protein that builds up in the brains of people with Alzheimer’s disease, which is thought to contribute to disease symptoms.
Study on Neflamapimod for Treating Dementia with Lewy Bodies in Patients Aged 55 and Older
This Dutch study evaluates whether Neflamapimod can improve symptoms in people with Dementia with Lewy Bodies, a progressive condition affecting thinking, movement, and behavior.
Main inclusion criteria: Participants must be men and women aged 55 years or older, willing and able to provide written consent. They must have a diagnosis of probable Dementia with Lewy Bodies based on a positive DaTscan (brain scan) or, if the scan is negative, a history of REM sleep behavioral disorder confirmed by a sleep study. The Clinical Dementia Rating Global Score must be less than 2.0 at screening. Those taking cholinesterase inhibitor therapy must have been on treatment for more than 3 months with a stable dose for at least 6 weeks, or have stopped the medication at least 3 months before starting the study. Participants must have normal or corrected vision and hearing, no history of learning difficulties, SARS-CoV-19 vaccination (unless medically contraindicated or previously infected), and a reliable informant or caregiver.
Main exclusion criteria: People younger than 55 years, those without a diagnosis of probable Dementia with Lewy Bodies, without a positive DaTscan, without a Clinical Dementia Rating Global Score of 0.5 or 1.0, and without a history of REM sleep behavioral disorder verified by polysomnography are excluded.
Study focus: The 16-week trial compares Neflamapimod (40 mg taken twice daily) with placebo to evaluate effectiveness in improving dementia symptoms. Participants undergo baseline assessments of cognitive and functional abilities, including tests measuring attention, executive function, and visual learning. Regular follow-up visits monitor health, side effects, and medication adherence. Final assessments compare changes between those receiving Neflamapimod and placebo to determine treatment effectiveness.
Investigational drugs: Neflamapimod is a kinase inhibitor that blocks a specific enzyme called P38 Alpha Kinase, believed to play a role in inflammation processes associated with neurodegenerative diseases. It is taken orally as a capsule and aims to improve cognitive function by slowing or stopping damage to brain cells.
Summary
The current landscape of clinical trials for dementia shows diverse research approaches across Europe, with concentrations in the Netherlands (3 trials), Germany (2 trials), and single trials in Sweden and Italy. Research efforts focus on three main areas: diagnostic imaging techniques, disease-modifying treatments, and symptom management.
A significant portion of trials emphasizes improving diagnostic accuracy through advanced imaging methods. Multiple studies test PET imaging agents that detect specific brain proteins associated with different forms of dementia, including amyloid plaques and tau proteins. These trials aim to enhance early detection and diagnostic certainty for conditions like Alzheimer’s disease and other neurodegenerative disorders.
Treatment-focused trials include novel approaches for specific dementia types. Studies test medications like Donanemab for early Alzheimer’s disease, Neflamapimod for Dementia with Lewy Bodies, and Efgartigimod for autoimmune dementia. Additionally, one trial addresses the challenging issue of agitated behavior in nursing home residents with dementia, comparing medications when standard treatments have failed.
Most trials require participants aged 50 or older, though age criteria vary by specific condition. Common requirements include confirmed diagnosis through specialized assessments, ability to undergo brain scans, and presence of a caregiver or informant. Exclusion criteria typically focus on other serious medical conditions, recent substance abuse, pregnancy, and inability to comply with study procedures.
The geographic distribution and variety of approaches reflect ongoing efforts to address different aspects of dementia care, from earlier and more accurate diagnosis to targeted treatments for specific disease types and symptom management.
