Senile dementia Trials in Disease

Study on the Benefits of Amyloid PET Imaging with Florbetaben (18F) and Flutemetamol (18F) for Patients with Various Types of Dementia

This trial is investigating whether a special type of brain scan called amyloid PET imaging can provide better information for diagnosing and managing different types of dementia compared to standard diagnostic methods. The study is being conducted in Germany and focuses on patients with various forms of the condition, including Alzheimer's disease, vascular dementia, and dementia related to other conditions such as Parkinson's disease and HIV.

Main inclusion criteria:

• Patients must be at least 50 years old
• Must have mild to moderate dementia with a Clinical Dementia Rating Scale score greater than 0.5 and less than 3.0
• Must have a Mini-Mental-Status Test score greater than 10
• Must have an unclear diagnosis of dementia or uncertain diagnosis of Alzheimer's disease, with less than 85% certainty
• Must have valid health insurance from a German compulsory health insurance
• Must have someone who can provide information about them, such as a family member or friend
• Cannot have a diagnosis made by examining cerebrospinal fluid, either due to medical reasons, patient refusal, or unclear results
• Must be willing to undergo amyloid PET imaging and agree to know the result

Main exclusion criteria:

• Patients with confirmed diagnoses of specific types of dementia, including Parkinson's disease with dementia, any type of Alzheimer's disease, vascular dementia, or HIV-related dementia
• Patients with rare brain disorders such as Pick's disease, Huntington's disease, or Creutzfeldt-Jakob disease who have dementia
• Patients with any other specified diseases that cause dementia

Focus and goal: The trial aims to determine whether amyloid PET imaging can improve the understanding and treatment of dementia compared to current diagnostic methods. Participants will be randomly assigned to either receive the amyloid PET imaging or standard diagnostic procedures. The study will track changes in cognitive performance, quality of life, and the ability to manage daily activities over a period of 104 weeks. Follow-up assessments will occur at 26, 52, 78, and 104 weeks after joining the study.

Investigational imaging technique: The trial uses amyloid PET imaging with either Neuraceq or VIZAMYL solution for injection, which contain substances called florbetaben (18F) or flutemetamol (18F). These substances help highlight certain areas of the brain during the scan, specifically detecting amyloid plaques that are associated with Alzheimer's disease and other forms of dementia. The imaging involves an intravenous injection and is designed to provide a clearer picture of the brain's condition, potentially leading to better diagnosis and treatment planning.

Summary

Currently, there is one ongoing clinical trial for senile dementia, located in Germany. This trial focuses on evaluating the benefits of amyloid PET imaging as a diagnostic tool for patients with various types of dementia. The study specifically targets individuals with unclear or uncertain diagnoses, aiming to improve diagnostic accuracy and treatment planning through advanced brain imaging techniques. The trial uses specialized imaging agents, florbetaben (18F) and flutemetamol (18F), to detect amyloid plaques in the brain. Participants will be monitored over a two-year period to assess the impact of this imaging on their cognitive performance, quality of life, and overall disease management.