Ongoing Clinical Trials for Prodromal Alzheimer’s Disease
Three clinical trials are currently recruiting patients with prodromal Alzheimer’s disease, also known as early-stage Alzheimer’s disease or mild cognitive impairment due to Alzheimer’s disease. These studies are investigating new diagnostic methods and potential treatments aimed at slowing cognitive decline in the early stages of this condition. The trials are taking place across multiple European countries including Austria, France, Germany, Italy, Poland, Spain, and Sweden.
Clinical trial locations
- Austria
- France
- Germany
- Italy
- Poland
- 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 study, conducted in Sweden, focuses on improving the early diagnosis of neurodegenerative disorders, particularly Alzheimer’s disease. The trial uses advanced brain imaging techniques to identify people at risk of developing dementia.
Main focus: The study aims to test the accuracy of two special imaging substances called Tau PET and Vizamyl in detecting early brain changes associated with Alzheimer’s disease and related conditions. Participants will undergo brain scans that show whether harmful proteins are building up in their brains, which could indicate a higher risk of dementia.
Who can participate: The study accepts adults between 20 and 100 years of age who are fluent in Swedish. Participants must agree to undergo at least one lumbar puncture, an MRI brain scan, and cognitive testing. The study includes three groups: healthy elderly individuals with no cognitive symptoms and normal test results, people with mild cognitive impairment who maintain most daily functions, and people with dementia who meet diagnostic criteria for cognitive decline.
Who cannot participate: The study excludes patients already diagnosed with neurodegenerative disorders involving tau-pathology, including Alzheimer’s disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration, or those not at high risk of developing dementia.
Investigational substances used: Tau PET (18F-RO6958948) is an imaging agent that helps detect tau protein buildup in the brain, while Vizamyl (18F-Flutemetamol) detects amyloid plaques. Both substances are used in specialized brain scans to identify changes that might indicate Alzheimer’s disease or related conditions.
Study on the Effects of AD04 and Placebo in Patients with Early Alzheimer’s Disease
This clinical trial, taking place in Austria and Poland, investigates whether a treatment called AD04 can slow the progression of early Alzheimer’s disease over a six-month period.
Main focus: The study tests whether AD04, given as an injection under the skin, can help preserve thinking abilities, daily functioning, and overall well-being in people with early-stage Alzheimer’s disease. Researchers will compare participants receiving AD04 with those receiving a placebo to measure any differences in disease progression.
Who can participate: The study accepts people aged 50 to 85 years with a diagnosis of probable Alzheimer’s disease. Participants must score between 22 and 30 on the Mini-Mental State Examination and show specific brain changes on MRI scans or cerebrospinal fluid tests. Each participant needs a partner or caregiver who knows them well and can spend at least 10 hours per week with them. Vision and hearing must be adequate for cognitive testing, and participants must agree to use effective birth control if applicable.
Who cannot participate: The study excludes people with other serious health conditions that could interfere with the trial, those currently in another clinical trial, people with recent major surgery planned, anyone with severe allergic reactions to medications, pregnant or breastfeeding women, people with unstable mental health conditions, those with different types of dementia, and individuals with a history of stroke or significant brain injury.
Investigational drug used: AD04 is an experimental medication containing aluminium hydroxide, administered through subcutaneous injection. The study examines whether it can slow cognitive decline and preserve daily functioning in early Alzheimer’s disease patients.
Study of Lecanemab (BAN2401) Treatment in People with Early Alzheimer’s Disease: Testing Safety and Effectiveness Over 18 Months
This large-scale study, conducted across Spain, Germany, Sweden, France, and Italy, tests lecanemab (also called BAN2401), a medication designed to target and remove harmful proteins believed to drive Alzheimer’s disease progression.
Main focus: The study evaluates whether lecanemab can slow cognitive decline and improve daily functioning in people with early Alzheimer’s disease. The trial consists of an 18-month main phase followed by an extension phase where all participants can receive the actual medication. Treatment may last up to 48 months in total.
Who can participate: Adults aged 50 to 90 years with a Body Mass Index between 17 and 35 can participate. Eligible participants must have experienced gradual memory decline for at least one year, confirmed by a family member or friend, and score between 22 and 30 on the Mini-Mental State Examination. Each participant needs a study partner who spends at least 8 hours per week with them and can attend visits. Participants must show evidence of brain amyloid through either a PET scan or spinal fluid test, and demonstrate memory impairment on specific tests. Those taking Alzheimer’s medications must be on stable doses for at least 12 weeks before starting.
Who cannot participate: The study excludes people outside the age range, those with other neurological disorders affecting mental function, anyone with a history of brain bleeding or multiple strokes, people taking blood-thinning medications (except low-dose aspirin), those with significant psychiatric illness in the past six months, individuals with alcohol or substance abuse history in the past five years, people with severe liver or kidney disease, those with unstable heart disease, uncontrolled high blood pressure, active cancer, pregnancy or breastfeeding, and anyone unable to undergo MRI scans.
Investigational drug used: Lecanemab (BAN2401) is a monoclonal antibody given through intravenous infusion. It works by targeting and removing toxic beta-amyloid protein aggregates in the brain, which are believed to contribute to Alzheimer’s disease progression. The medication is being studied as a disease-modifying therapy that may slow cognitive decline.
Summary
The three ongoing trials for prodromal Alzheimer’s disease represent different approaches to addressing this condition. One study in Sweden focuses on improving diagnostic accuracy through advanced brain imaging techniques, helping identify at-risk individuals earlier. The other two trials test potential treatments: AD04 in Austria and Poland, and lecanemab across five European countries including Spain, Germany, Sweden, France, and Italy.
The largest geographical coverage belongs to the lecanemab study, reflecting its advanced stage of development and broader investigation. This trial also offers the longest treatment duration, up to 48 months, compared to the six-month AD04 study. All studies require participants to have partners or caregivers involved, recognizing the importance of support in managing early-stage cognitive decline.
Each trial targets slightly different aspects of early Alzheimer’s disease, from diagnosis to treatment, with the Swedish diagnostic study expected to conclude by February 2028 and the lecanemab trial continuing until approximately November 2026. These studies collectively aim to improve both the detection and management of prodromal Alzheimer’s disease in European populations.
