Ongoing Clinical Trials for Early Onset Familial Alzheimer’s Disease
There are currently 4 clinical trials investigating new diagnostic methods and potential treatments for early onset familial Alzheimer’s disease. These studies are taking place across several European countries, including Sweden, Germany, Austria, Poland, Spain, Italy, and Portugal, and focus on improving diagnosis through advanced brain imaging techniques and testing investigational medications aimed at slowing disease progression.
Clinical trial locations
- Austria
- Espagne
- Germany
- Italy
- Poland
- Portugal
- Spain
- 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, including early onset familial Alzheimer’s disease, by using advanced brain imaging techniques. The trial aims to help doctors identify people at risk of developing dementia before symptoms become severe.
Who can participate: The study accepts participants between 20 and 100 years old who are fluent in Swedish. All participants must agree to undergo at least one lumbar puncture (a procedure to collect spinal fluid for testing), an MRI brain scan, and neuropsychological testing (tests that measure memory, attention, and problem-solving). The study includes three groups: healthy elderly people with no memory problems and normal cognitive test results, people with mild cognitive impairment who still manage daily activities well enough that dementia cannot be diagnosed, and people with dementia who meet the criteria for a dementia diagnosis.
Who cannot participate: People already diagnosed with other neurodegenerative disorders involving tau protein buildup are excluded. This includes those with conditions like progressive supranuclear palsy, frontotemporal dementia, or corticobasal degeneration. Additionally, people who are not at high risk of developing dementia are not eligible for this particular study.
Study purpose: The trial evaluates two imaging substances: Tau PET (18F-RO6958948), which helps doctors see tau protein buildup in the brain, and Vizamyl (Flutemetamol 18F), which detects amyloid plaques. Both tau and amyloid are proteins that accumulate in the brains of people with Alzheimer’s disease. By comparing brain scans from people with these disorders to those of healthy individuals, researchers hope to better understand the differences and improve early detection.
Investigational substances: This study uses two diagnostic imaging agents. Tau PET (18F-RO6958948) is injected into the body to highlight tau protein in brain scans, helping doctors assess dementia risk. Vizamyl (Flutemetamol 18F) works similarly but targets amyloid plaques instead, another key indicator of Alzheimer’s disease risk.
Study on the Benefits of Amyloid PET Imaging with Florbetaben (18F) and Flutemetamol (18F) for Patients with Various Types of Dementia
This German trial investigates whether amyloid PET imaging can improve the diagnosis and management of various types of dementia compared to standard diagnostic methods. The study specifically looks at whether this advanced imaging can lead to better treatment decisions and improved quality of life.
Who can participate: Eligible participants must be at least 50 years old with valid German health insurance. They need someone who knows them well, such as a family member or friend, who can provide information about them. Participants should have mild to moderate dementia with a Clinical Dementia Rating score greater than 0.5 but less than 3.0, and a Mini-Mental-Status Test score greater than 10. They must have an unclear dementia diagnosis or uncertain Alzheimer’s diagnosis (less than 85% certainty), but Alzheimer’s disease cannot be completely ruled out (at least 15% probability). Participants must be willing to undergo amyloid PET diagnostics if selected for that part of the study.
Who cannot participate: People with confirmed diagnoses of specific dementia types are excluded, including Parkinson’s disease with dementia, any type of Alzheimer’s disease, vascular dementia, HIV-related dementia, Pick’s disease, Huntington’s disease with dementia, or Creutzfeldt-Jakob disease with dementia.
Study purpose: The trial compares outcomes between patients who receive amyloid PET imaging and those who receive standard diagnostic procedures. Researchers will track changes in cognitive performance, quality of life, and care needs over 104 weeks through follow-up assessments at 26, 52, 78, and 104 weeks after randomization.
Investigational substances: The study uses amyloid PET imaging with either Neuraceq (Florbetaben 18F) or Vizamyl (Flutemetamol 18F). These substances are injected intravenously and help visualize amyloid plaques in the brain during PET scans, potentially leading to more accurate diagnoses.
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 the investigational treatment to a placebo over a six-month period.
Who can participate: Participants must be between 50 and 85 years old with a diagnosis of probable Alzheimer’s disease. They need a partner or caregiver who knows them well and can accompany them to visits, spending at least 10 hours per week with them. Participants must have a Mini-Mental State Examination score between 22 and 30, indicating mild to moderate cognitive impairment. Brain MRI must show shrinkage in a specific brain region, or cerebrospinal fluid tests must show a pattern consistent with Alzheimer’s disease. Memory test results must indicate problems related to the hippocampus, the brain’s memory center. Women of childbearing age and men with female partners who can have children must use two effective methods of birth control during the trial and for 90 days afterward.
Who cannot participate: People with other serious health conditions that might interfere with the study, those currently in another clinical trial, recent major surgery patients, those with severe allergic reactions to medications, inability to comply with study procedures, history of drug or alcohol abuse, pregnant or breastfeeding women, unstable or serious mental health conditions, different types of dementia diagnoses, or significant brain injury or stroke are excluded.
Study purpose: The trial evaluates whether AD04 can slow cognitive decline and help maintain patients’ ability to perform daily activities and overall well-being over six months. Participants receive subcutaneous injections (under the skin) of either AD04 or placebo, and researchers track changes through regular cognitive assessments and brain imaging.
Investigational drug: AD04 contains aluminium hydroxide and is being studied for its potential to slow the progression of early Alzheimer’s disease by targeting specific pathways in the brain involved in disease progression.
Study on the Safety and Effects of ABBV-916 and MK-6240 for Patients with Early Alzheimer’s Disease
This multinational trial, taking place in Spain, Italy, and Portugal, evaluates ABBV-916, a monoclonal antibody designed to target and reduce harmful substances in the brain associated with Alzheimer’s disease. The study compares this treatment to a placebo.
Who can participate: Adults between 50 and 90 years old with adequate reading, writing, vision, and hearing abilities to complete required tests are eligible. Participants must have a Mini-Mental State Examination score between 20 and 28, indicating mild cognitive impairment. Blood test results must suggest the presence of amyloid protein, and brain scans must show amyloid buildup with a centiloid value of 37 or higher, confirmed by visual assessment.
Who cannot participate: People without an Alzheimer’s disease diagnosis, those outside the specified age range, and individuals considered part of vulnerable populations requiring special protection cannot participate.
Study purpose: The trial assesses the safety and effectiveness of ABBV-916 in reducing amyloid plaques in the brain. Participants receive the medication through intravenous infusion, and researchers monitor brain changes over time using specialized imaging, including amyloid PET scans at week 24. The study also uses MK-6240 to help measure these changes.
Investigational drug: ABBV-916 is a monoclonal antibody administered through intravenous infusion. It is designed to reduce amyloid levels in the brain, potentially slowing the progression of Alzheimer’s disease and improving symptoms by targeting specific proteins believed to play a role in the condition’s development.
Summary
The four ongoing clinical trials for early onset familial Alzheimer’s disease reflect both diagnostic innovation and treatment development efforts. Two trials focus primarily on improving diagnostic accuracy through advanced brain imaging techniques, particularly PET scans that can detect tau protein and amyloid plaques. These studies in Sweden and Germany aim to identify at-risk individuals earlier and improve the precision of dementia diagnoses.
The remaining two trials test investigational medications: AD04 in Austria and Poland, and ABBV-916 in Spain, Italy, and Portugal. Both studies target the reduction of harmful brain proteins associated with disease progression. The trials vary in their inclusion criteria, with some accepting participants with very mild cognitive symptoms and others requiring confirmed diagnoses.
Geographically, the trials span multiple European countries, with Southern European nations (Spain, Italy, Portugal) hosting the ABBV-916 study and Central European countries (Austria, Poland, Germany) participating in other investigations. This distribution suggests a coordinated European approach to understanding and treating this challenging condition. All trials emphasize the importance of early intervention and accurate diagnosis in managing this form of Alzheimer’s disease.
