Ongoing Clinical Trials for Dementia of the Alzheimer’s Type with Delusions
There are currently 3 ongoing clinical trials investigating new treatments and diagnostic methods for dementia of the Alzheimer’s type with delusions. These studies are taking place across multiple European countries and focus on testing medications to manage psychosis symptoms, improving diagnostic accuracy through advanced brain imaging, and exploring potential treatments to slow disease progression.
Clinical trial locations
- Austria
- Bulgaria
- Croatia
- Czechia
- Poland
- Romania
- Slovakia
- Spain
- Sweden
Study on ITI-1284 for Treating Psychosis in Alzheimer’s Patients
This trial is testing ITI-1284, a medication designed to help manage psychosis symptoms in people with Alzheimer’s disease. Psychosis can cause individuals to see or hear things that are not there or hold false beliefs, which can significantly affect their quality of life and behavior.
Who can participate: The study is looking for patients aged 55 or older who have been diagnosed with Alzheimer’s disease and are experiencing psychosis symptoms. Participants must have had these symptoms for at least one month, and the symptoms need to be severe enough to affect daily activities. Patients need to score at least 2 on certain items of the BEHAVE-AD test, which measures psychosis symptoms, and have a score of 4 or higher on the Clinical Global Impression-Severity scale. They should also score between 6 and 24 on the Mini-Mental State Examination. Participants must live at home or in a care facility and be able to visit the clinic. If living at home, they cannot live alone and must have been at their current location for at least 4 weeks before starting the study.
Who cannot participate: The trial excludes patients who have any other type of psychosis not related to Alzheimer’s disease, those participating in another clinical trial, or those with serious medical conditions that might interfere with the study.
What the study involves: Participants will take ITI-1284 or a placebo once daily in the form of a sublingual tablet, which dissolves under the tongue. The treatment period lasts six weeks, during which participants will have weekly assessments to monitor their response to the medication. The study is double-blind, meaning neither participants nor researchers know who is receiving the actual medication or the placebo. This helps ensure the results are not influenced by expectations. Researchers will evaluate changes in psychosis symptoms using the BEHAVE-AD scale and assess overall condition using the CGI-S scale.
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 focuses on improving the diagnosis of brain disorders, including Alzheimer’s disease, using advanced imaging techniques. The research uses two special substances, Tau PET ([18F]RO6958948) and Vizamyl (Flutemetamol 18F), which help doctors see changes in the brain through PET scans.
Who can participate: The study is open to people between 20 and 100 years of age who are fluent in Swedish. Participants must agree to undergo at least one lumbar puncture, an MRI scan of the brain, and neuropsychological testing. The study includes healthy elderly individuals with no cognitive symptoms, people with mild cognitive impairment, and those with dementia. Healthy participants should show normal performance on cognitive tests and have preserved thinking and daily functioning. Those with mild cognitive impairment should have cognitive symptoms but still maintain enough daily functioning that dementia cannot be diagnosed. Participants with dementia should meet the criteria for a dementia diagnosis at the study’s start.
Who cannot participate: The study excludes patients with other neurodegenerative disorders involving tau-pathology, such as progressive supranuclear palsy, frontotemporal dementia, or corticobasal degeneration, unless they fit the specific diagnostic criteria being studied.
What the study involves: Participants will receive an injection of Vizamyl, which helps visualize amyloid plaques in the brain, and undergo PET scans to detect tau protein accumulation. The study will compare brain scan results with other diagnostic methods, such as cerebrospinal fluid biomarkers and MRI findings. Follow-up assessments will monitor changes in cognitive function over time. The study aims to improve understanding of cognitive disorders and enhance diagnostic accuracy, with completion estimated by February 2028.
Study on the Effects of AD04 and Placebo in Patients with Early Alzheimer’s Disease
This clinical trial is investigating whether AD04, a treatment containing aluminium hydroxide, can help slow the progression of early Alzheimer’s disease. The study will compare the effects of AD04 with a placebo over a six-month period.
Who can participate: The study is seeking participants aged between 50 and 85 years old who have a diagnosis of probable Alzheimer’s disease. Participants must have a partner or caregiver who knows them well and can accompany them to visits, spending at least 10 hours per week with them. They need to score between 22 and 30 on the Mini-Mental State Examination and have a brain MRI showing shrinkage in specific brain areas or specific patterns in cerebrospinal fluid tests related to Alzheimer’s. Results from memory tests should indicate memory problems related to the hippocampus. Physical examinations, including vision and hearing tests, should be within acceptable ranges for their age. Participants must also score 4 or less on the Hachinski Ischemia Scale and provide written informed consent.
Who cannot participate: The trial excludes patients with other serious health conditions that might interfere with the study, those currently participating in another clinical trial, those who have had recent major surgery or are planning surgery during the study period, those with a history of severe allergic reactions to medications, drug or alcohol abuse, or those who are pregnant or breastfeeding. Patients with unstable mental health conditions, a different type of dementia, or a history of stroke or significant brain injury are also excluded.
What the study involves: Participants will be randomly assigned to receive either AD04 or a placebo through subcutaneous injections given under the skin. The study will last six months, during which participants will attend regular follow-up visits. During these visits, healthcare professionals will monitor health and assess treatment effects through cognitive and functional assessments. The study will also track any side effects or adverse events. At the end of the six-month period, a final assessment will measure any changes in condition, helping determine whether AD04 can provide meaningful benefits in slowing disease progression.
Summary
The three ongoing clinical trials for dementia of the Alzheimer’s type with delusions represent different approaches to addressing this challenging condition. One trial focuses specifically on managing psychosis symptoms with ITI-1284, which is being tested across seven European countries including Spain, Bulgaria, Slovakia, Romania, Czechia, Croatia, and Poland. This broad geographic distribution suggests significant interest in finding effective treatments for the distressing symptoms of psychosis in Alzheimer’s patients.
Another study takes a diagnostic approach, using advanced imaging techniques with Tau PET and Vizamyl in Sweden to improve early detection and understanding of cognitive decline. This research may help identify at-risk individuals earlier and improve diagnostic accuracy.
The third trial, conducted in Austria and Poland, explores whether AD04 can slow the progression of early Alzheimer’s disease itself, representing a potential disease-modifying approach rather than just symptom management.
Together, these trials reflect the multifaceted nature of Alzheimer’s research, addressing symptom management, diagnostic accuracy, and potential disease modification. The concentration of studies in Central and Eastern European countries, particularly Poland’s participation in two of the three trials, indicates active research infrastructure in these regions for neurodegenerative disease studies.
