Clinical Trials for Mixed Dementia
There are currently 3 ongoing clinical trials investigating diagnostic imaging techniques and potential treatments for mixed dementia and related neurodegenerative disorders. These studies are taking place in Sweden, Germany, Austria, and Poland, and focus on improving early detection and slowing disease progression.
Clinical trial locations
- Austria
- Germany
- Poland
- 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, conducted in Sweden, aims to improve the diagnosis of neurodegenerative disorders including Alzheimer’s disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration, and mild cognitive impairment. The trial uses advanced brain imaging techniques to help identify people at risk of developing dementia.
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. Healthy elderly participants should have no cognitive symptoms and normal performance on cognitive tests. Those with mild cognitive impairment should have preserved general thinking and daily functioning sufficient that dementia cannot be diagnosed. Participants with dementia must meet the criteria for a dementia diagnosis at the study start.
Main exclusion criteria: The study excludes patients with neurodegenerative disorders involving tau-pathology who are not at high risk of developing dementia due to Alzheimer’s disease or similar conditions.
Focus and goals: The study compares brain scans using specialized imaging substances with other diagnostic methods such as cerebrospinal fluid biomarkers and MRI findings. Participants undergo initial assessments, baseline cognitive testing, imaging procedures, and follow-up assessments to monitor changes in cognitive function over time. The study is scheduled to conclude in February 2028.
Investigational drugs: The trial uses two imaging agents: Tau PET (18F-RO6958948), which helps visualize tau protein buildup in the brain, and Vizamyl (18F-Flutemetamol), which detects amyloid plaques. Both are administered through injection and provide detailed brain images that help doctors assess the risk of Alzheimer’s disease and other neurodegenerative disorders.
Study on the Benefits of Amyloid PET Imaging with Florbetaben (18F) and Flutemetamol (18F) for Patients with Various Types of Dementia
This German study investigates whether amyloid PET imaging provides better diagnostic information than standard methods for people with different types of dementia, including Alzheimer’s disease, vascular dementia, and dementia related to Parkinson’s disease and HIV.
Main inclusion criteria: Participants must be at least 50 years old with valid German health insurance and have someone who can provide information about them. They must have mild to moderate dementia syndrome with 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 uncertain (less than 85% certainty), with at least a 15% probability of Alzheimer’s disease. Participants must be unable to have a cerebrospinal fluid test due to medical reasons, refusal, or unclear diagnosis after testing, and must be willing to undergo amyloid PET diagnostics.
Main exclusion criteria: The study excludes patients with various types of dementia, including Parkinson’s disease with dementia, any type of Alzheimer’s disease, vascular dementia, HIV-related dementia, Pick’s disease, Huntington’s disease, and Creutzfeldt-Jakob disease with dementia.
Focus and goals: The trial randomly assigns participants to either receive amyloid PET imaging or standard diagnostic procedures. Follow-up assessments occur at 26, 52, 78, and 104 weeks to measure cognitive performance, quality of life, and care needs. The goal is to determine if amyloid PET imaging can improve understanding and treatment of dementia.
Investigational drugs: The study uses amyloid PET imaging with either Neuraceq (containing florbetaben 18F) or VIZAMYL (containing flutemetamol 18F). These radioactive tracers are administered through intravenous injection and bind to amyloid plaques in the brain, making them visible on PET scans to help detect Alzheimer’s disease.
Study on the Effects of AD04 and Placebo in Patients with Early Alzheimer’s Disease
This trial, conducted in Austria and Poland, tests whether AD04 can slow the progression of early Alzheimer’s disease. The study compares AD04 with a placebo over six months, evaluating improvements in cognitive abilities, daily functioning, and overall health.
Main inclusion criteria: Participants must be between 50 and 85 years old with a partner or caregiver who knows them well and has at least 10 hours of weekly contact. Those of childbearing potential must use effective birth control. Participants must have a diagnosis of probable Alzheimer’s disease with a Mini-Mental State Examination score between 22 and 30. Brain MRI must show shrinkage in specific areas, or cerebrospinal fluid tests must show patterns related to Alzheimer’s disease. Memory tests must indicate problems related to the hippocampus. Physical examination results, including vision and hearing, must be within acceptable ranges, and participants must score 4 or less on the Hachinski Ischemia Scale.
Main exclusion criteria: The study excludes patients with other serious health conditions that might interfere with the study, those participating in another trial, patients with recent or planned surgery, history of severe allergic reactions, inability to comply with procedures, history of drug or alcohol abuse, pregnancy or breastfeeding, unstable mental health conditions, diagnosis of a different type of dementia, or history of stroke or significant brain injury.
Focus and goals: Participants receive either AD04 or placebo through subcutaneous injections under the skin. The study monitors cognitive function, daily activities, and overall well-being through regular assessments including brain imaging. Neither participants nor researchers know who receives the actual treatment, ensuring unbiased results.
Investigational drugs: AD04 is an investigational medication containing aluminum hydroxide, administered as an injection solution. It targets specific pathways in the brain involved in disease progression, though the exact mechanism is still being researched. The goal is to slow down the worsening of memory, thinking, and behavioral symptoms in early Alzheimer’s disease.
Summary
The three ongoing clinical trials represent different approaches to addressing mixed dementia and related conditions. Two of the studies focus on advanced diagnostic imaging techniques using PET scans to detect amyloid plaques and tau proteins in the brain, which are hallmarks of Alzheimer’s disease. These diagnostic trials are being conducted in Sweden and Germany and aim to improve early detection and accuracy of dementia diagnosis.
The third trial, conducted in Austria and Poland, takes a different approach by testing a potential treatment called AD04 that aims to slow disease progression in patients with early Alzheimer’s disease. All three studies emphasize the importance of early intervention and accurate diagnosis in managing these complex neurodegenerative conditions.
The trials reflect growing international collaboration in dementia research, with studies spanning multiple European countries. The focus on both diagnostic accuracy and therapeutic intervention demonstrates the multifaceted approach needed to address the challenges posed by these debilitating conditions.
