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

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What is this study about?

This clinical trial is focused on studying the benefits of using a special type of brain scan called amyloid PET imaging for people with different types of dementia. Dementia is a condition that affects memory, thinking, and the ability to perform everyday activities. The study includes various forms of dementia, such as Alzheimer’s disease, vascular dementia, and dementia related to other conditions like Parkinson’s disease and HIV. The trial aims to see if amyloid PET imaging can provide better information compared to standard methods without this imaging.

Participants in the study will receive either the amyloid PET imaging or standard diagnostic procedures. The imaging involves using a solution for injection, such as Neuraceq or VIZAMYL, which contains substances like florbetaben (18F) or flutemetamol (18F). These substances help highlight certain areas of the brain during the scan. The study will observe how this imaging affects the management of daily activities and overall quality of life for those with dementia.

The trial will last for several weeks, with follow-up assessments to monitor changes in cognitive performance, quality of life, and any potential side effects. The goal is to determine if amyloid PET imaging can improve the understanding and treatment of dementia compared to current diagnostic methods. Participants will be monitored by healthcare professionals throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, insurance coverage, and dementia diagnosis.

Written informed consent is required, either by the patient or a legal representative.

2 initial assessment

An initial assessment is conducted to evaluate the severity of dementia using tools like the Clinical Dementia Rating Scale and the Mini-Mental-Status Test.

The assessment helps determine the suitability for amyloid PET imaging.

3 randomization

Participants are randomly assigned to either the amyloid PET imaging group or the control group.

Those in the amyloid PET group will undergo the imaging procedure.

4 amyloid PET imaging

For those in the amyloid PET group, the imaging involves an intravenous injection of either Neuraceq or VIZAMYL solution.

The procedure aims to provide a clearer diagnosis of dementia.

5 follow-up assessments

Follow-up assessments occur at 26, 52, 78, and 104 weeks after randomization.

These assessments measure cognitive performance, quality of life, and the need for care.

6 final evaluation

A final evaluation is conducted to assess the ability to manage daily activities and any changes in dementia diagnosis.

The evaluation also considers any adverse events experienced during the trial.

Who Can Join the Study?

  • Be at least 50 years old.
  • Have someone who can provide information about you, like a family member or friend.
  • Have valid health insurance from a German compulsory health insurance.
  • Have mild to moderate dementia syndrome. Dementia syndrome refers to a group of symptoms affecting memory, thinking, and social abilities.
  • Have a Clinical Dementia Rating Scale (CDR) score greater than 0.5 and less than 3.0. The CDR is a tool used to assess the severity of dementia.
  • Have a Mini-Mental-Status Test (MMSE) score greater than 10. The MMSE is a test that measures cognitive function.
  • Have an unclear diagnosis of dementia or uncertain diagnosis of Alzheimer’s disease, meaning the certainty of the diagnosis is less than 85%.
  • Have a diagnosis of Alzheimer’s disease with at least a 15% probability, meaning Alzheimer’s disease cannot be completely ruled out.
  • Cannot have a diagnosis made by examining the CSF (cerebrospinal fluid) because: a) there is a medical reason not to do the CSF test, b) you refuse the CSF test, or c) the diagnosis is still unclear after the CSF test.
  • Be willing to undergo amyloid PET diagnostics and agree to know the result if selected for this part of the study. Amyloid PET is a type of brain scan used to detect amyloid plaques, which are associated with Alzheimer’s disease.
  • Provide written informed consent, either by yourself or through a legal representative, based on what you would likely want.

Who Cannot Join the Study?

  • Patients with any type of dementia cannot participate. Dementia is a condition that affects memory, thinking, and social abilities.
  • Patients with Parkinson’s disease who also have dementia are excluded. Parkinson’s disease is a disorder that affects movement.
  • Patients with Alzheimer’s disease of any type, including early or late onset, are not eligible. Alzheimer’s disease is a common form of dementia.
  • Patients with vascular dementia are excluded. Vascular dementia is caused by problems in the blood supply to the brain.
  • Patients with HIV who have dementia cannot participate. HIV is a virus that attacks the immune system.
  • Patients with Pick’s disease or Huntington’s disease who have dementia are not eligible. These are rare brain disorders.
  • Patients with Creutzfeldt-Jakob disease who have dementia are excluded. This is a rare, degenerative brain disorder.
  • Patients with any other specified diseases that cause dementia are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Rostock University Medical Center Rostock Germany
University Medicine Greifswald Greifswald Germany
Universitaetsmedizin Goettingen Goettingen Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universitaetsklinikum Essen AöR Essen Germany
Philipps University Marburg Marburg Germany
Central Institute of Mental Health Mannheim Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V. Bonn Germany
Uljjlhpojlapfwzlgjema Gxfxygl uzm Maezebd Gvss Marburg Germany
Kwnmxdlu djr Uojqcsgfkdac Milkilnt Axg Munich Germany
Ujiwkrrpai Hgnrknsf Cpmxlyx Cologne Germany
Umgzwlofgr Makgnga Cmnhlg Hzjjmcbyukxexskwi Hamburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
09.09.2024

Trial locations

Amyloid PET Imaging is a type of brain scan used in this clinical trial to help detect amyloid plaques, which are associated with Alzheimer’s disease and other forms of dementia. The goal of using this imaging technique is to provide a clearer picture of the brain’s condition, potentially leading to better diagnosis and treatment planning for patients with dementia.

Dementia in Parkinson disease – This condition occurs in individuals with Parkinson’s disease, characterized by a decline in cognitive abilities such as memory, attention, and problem-solving. It typically progresses gradually, with symptoms worsening over time. Patients may experience difficulties with daily activities and changes in mood or behavior.

Dementia in Alzheimer disease, atypical or mixed type – This form of dementia involves symptoms that do not fit the typical pattern of Alzheimer’s disease, often including a mix of cognitive impairments. It progresses with a decline in memory, language, and other cognitive functions, affecting the ability to perform everyday tasks.

Vascular dementia, unspecified – This type of dementia is caused by problems in the blood supply to the brain, leading to cognitive decline. The progression can vary, with symptoms such as confusion, disorientation, and difficulty with concentration and communication.

Multi-infarct dementia – This condition results from multiple small strokes that cause damage to brain tissue, leading to a decline in cognitive abilities. It progresses in a stepwise manner, with sudden changes in symptoms following each stroke.

Dementia in other specified diseases classified elsewhere – This category includes dementia associated with various other medical conditions. The progression and symptoms depend on the underlying disease but generally involve a decline in cognitive functions.

Dementia in Alzheimer disease with late onset – This form of Alzheimer’s disease begins after the age of 65 and is characterized by a gradual decline in memory and cognitive abilities. It progresses slowly, affecting daily living activities and social interactions.

Dementia in Alzheimer disease, unspecified – This type of dementia involves a decline in cognitive functions without specific distinguishing features. It progresses with memory loss, confusion, and difficulties in communication and reasoning.

Mixed cortical and subcortical vascular dementia – This condition involves damage to both the cortex and subcortex areas of the brain due to vascular issues. It progresses with symptoms such as memory loss, confusion, and difficulties with movement and coordination.

Dementia in human immunodeficiency virus [HIV] disease – This form of dementia occurs in individuals with HIV, leading to cognitive decline due to the virus’s impact on the brain. It progresses with symptoms like forgetfulness, confusion, and difficulty concentrating.

Dementia in Alzheimer disease with early onset – This type of Alzheimer’s disease begins before the age of 65, characterized by a rapid decline in cognitive abilities. It progresses with memory loss, language difficulties, and impaired judgment.

Subcortical vascular dementia – This condition is caused by small vessel disease affecting the subcortical regions of the brain, leading to cognitive decline. It progresses with symptoms such as slowed thinking, difficulty with attention, and changes in mood.

Dementia in Pick disease – This rare form of dementia is characterized by progressive damage to the frontal and temporal lobes of the brain. It progresses with changes in personality, behavior, and language abilities.

Dementia in Huntington disease – This condition occurs in individuals with Huntington’s disease, characterized by a decline in cognitive functions and motor skills. It progresses with symptoms such as memory loss, impaired judgment, and difficulty with movement.

Vascular dementia of acute onset – This type of dementia occurs suddenly following a major stroke or series of strokes. It progresses with symptoms like confusion, disorientation, and difficulties with speech and movement.

Unspecified dementia – This category includes dementia cases where the specific cause is not identified. It progresses with a general decline in cognitive abilities, affecting memory, communication, and daily activities.

Dementia in Creutzfeldt-Jakob disease – This rare and rapidly progressing form of dementia is caused by prion disease, leading to severe cognitive decline. It progresses with symptoms such as memory loss, personality changes, and impaired coordination.

Other vascular dementia – This category includes various forms of dementia caused by vascular issues not specified elsewhere. It progresses with cognitive decline, affecting memory, reasoning, and the ability to perform daily tasks.

Trial ID:
2023-503705-10-00
Protocol code:
PETAD01
Trial Phase:
Therapeutic confirmatory (Phase III)

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