Ongoing Clinical Trials for Dementia of the Alzheimer’s Type Uncomplicated
This article provides information about 3 ongoing clinical trials for patients with dementia of the Alzheimer’s type uncomplicated (also known as: Early Alzheimer’s Disease, Alzheimer’s Disease, Mild Cognitive Impairment due to Alzheimer’s). These trials are testing new diagnostic imaging techniques and investigational treatments aimed at improving diagnosis and slowing disease progression. The studies are being conducted across several European countries including Austria, Czechia, France, Germany, Poland, Slovakia, Spain, and Sweden.
Clinical trial locations
- Austria
- Czechia
- France
- Germany
- Poland
- Slovakia
- 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 diagnostic study is being conducted in Sweden and focuses on improving the early detection and diagnosis of neurodegenerative disorders including Alzheimer’s disease, mild cognitive impairment, progressive supranuclear palsy, frontotemporal dementia, and corticobasal degeneration. The study runs until February 2028.
Main inclusion criteria: Participants must be between 20 and 100 years old and fluent in Swedish. All participants must agree to undergo at least one lumbar puncture, an MRI brain scan, and neuropsychological testing. For healthy elderly participants, no cognitive symptoms should be present and normal cognitive test performance is required. For those with mild cognitive impairment, cognitive symptoms should be reported by the participant or someone close to them, but general thinking and daily functioning should be preserved enough that dementia cannot be diagnosed. For participants with dementia, cognitive symptoms must meet the criteria for a dementia diagnosis.
Main exclusion criteria: Patients with other neurodegenerative disorders involving tau-pathology are excluded. This specifically includes those with Alzheimer’s disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration, or mild cognitive impairment who are not at high risk of developing dementia.
Focus and goal: The study aims to evaluate how well two specialized brain imaging techniques can identify people at risk of developing dementia. Participants will undergo PET scans using either Vizamyl or Tau PET imaging agents to visualize abnormal protein deposits in the brain. The study will compare these imaging results with other diagnostic methods including cerebrospinal fluid biomarkers and MRI findings to improve diagnostic accuracy.
Investigational substances: The study 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 by injection and used with specialized PET scanning to provide detailed images of protein accumulation associated with neurodegenerative disorders.
Study on the Effects of AD04 and Placebo in Patients with Early Alzheimer’s Disease
This treatment study is being conducted in Austria and Poland and examines whether AD04 can slow the progression of early Alzheimer’s disease over a 6-month period. The trial compares AD04 with a placebo in a double-blind design.
Main inclusion criteria: Participants must be aged 50 to 85 years and have a partner or caregiver who knows them well and can accompany them to visits with at least 10 hours of weekly contact. A diagnosis of probable Alzheimer’s disease based on clinical and brain-related assessments is required, with an MMSE score between 22 and 30. Brain MRI must show atrophy in specific areas or CSF tests must show Alzheimer’s-related patterns. Memory test results must indicate hippocampus-related memory problems, and the Hachinski Ischemia Scale score must be 4 or less. Both women and men of reproductive potential must use two effective birth control methods during the trial and for 90 days after.
Main exclusion criteria: Patients with other serious health conditions that might interfere with the study are excluded. This includes those currently in another clinical trial, those with recent major surgery or planned surgery during the study, history of severe allergic reactions to medications, inability to comply with study procedures, history of drug or alcohol abuse, pregnancy or breastfeeding, unstable or serious mental health conditions, diagnosis with a different type of dementia, or history of stroke or significant brain injury.
Focus and goal: The study assesses whether AD04 can slow disease progression by evaluating improvements in cognitive abilities, daily functioning, and overall health. Participants receive either AD04 or placebo through subcutaneous injections. Regular assessments monitor cognitive function through tests like the MMSE, along with brain imaging using MRI to check for changes in brain structure, particularly in the medial temporal lobe.
Investigational drug: AD04 is an investigational medication containing aluminium hydroxide, administered as a solution for injection under the skin. It is being studied for its potential to slow the progression of early Alzheimer’s disease, though its exact mechanism is still being researched.
Study of XPro1595 for Patients with Early Alzheimer’s Disease and Inflammation Markers
This study is being conducted across multiple European countries including Spain, Poland, Czechia, Slovakia, France, and Germany. It examines whether XPro1595 can improve cognitive performance in patients with early Alzheimer’s disease who show signs of brain inflammation. The study is expected to continue until July 2025.
Main inclusion criteria: Adults aged 50 to 85 years with a diagnosis of mild cognitive impairment likely due to Alzheimer’s disease or mild dementia are eligible. Participants must have a Clinical Dementia Rating global score of 0.5 or 1, an MMSE score greater than 22, and an Everyday Cognition memory subscale mean greater than 1.5. Importantly, participants must have at least one inflammatory biomarker present, including hsCRP greater than 1.5 mg/L, ESR greater than 10 mm/h, HbA1C greater than 6%, or at least one APOE4 gene variant.
Main exclusion criteria: Patients without early Alzheimer’s disease with specific signs of inflammation cannot participate. Individuals outside the specified age range or who do not meet the required health conditions are excluded, as are vulnerable populations not included in the study design.
Focus and goal: The study investigates whether XPro1595 can improve cognitive performance by reducing inflammation in the brain. This is a double-blind, placebo-controlled trial lasting approximately 33 weeks. Participants undergo regular cognitive assessments using various tests including the International Shopping List Test, Digit Span, Category Fluency Test, Letter Fluency Test, Trail Making Test, and Digit Symbol Coding Test. Secondary assessments evaluate changes in the Clinical Dementia Rating Scale, Everyday Cognition, and Neuropsychiatric Inventory.
Investigational drug: XPro1595 is an investigational protein medication designed to target and reduce brain inflammation, which is believed to contribute to Alzheimer’s disease progression. It is administered as an injection and works by neutralizing specific inflammatory proteins at the molecular level. It is classified as an anti-inflammatory agent.
Summary
Three ongoing clinical trials are currently recruiting patients with dementia of the Alzheimer’s type uncomplicated across Europe. These studies represent two distinct approaches to addressing this condition: improved diagnostic imaging and investigational treatments targeting disease progression.
The diagnostic study in Sweden focuses on evaluating advanced PET imaging techniques using Tau PET and Vizamyl to improve early detection and risk assessment. This study has a notably broad age range from 20 to 100 years and includes healthy participants alongside those with cognitive impairment.
The two treatment trials take different therapeutic approaches. The AD04 study in Austria and Poland tests a medication containing aluminium hydroxide administered subcutaneously, while the XPro1595 study across multiple European countries focuses specifically on patients with inflammatory biomarkers, using an anti-inflammatory protein medication. The XPro1595 trial is the most geographically widespread, spanning seven European countries.
All three studies require participants to have caregivers or study partners available, reflecting the practical needs of conducting research in this patient population. The treatment studies specifically target early-stage disease with MMSE scores indicating mild cognitive impairment or mild dementia rather than advanced disease stages.
