ClinicalTrials.gov record NCT07154394
Cardiac Amyloid Deposits and Heart Dysfunction in Alzheimer's Disease
Investigation of Cardiac Amyloid Deposits as a Cause of Cardiac Dysfunction in Alzheimer's Disease (Untersuchung Von Kardialen Amyloidablagerungen Als Ursache Einer Funktionseinschränkung Des Herzens Bei Alzheimer Demenz)
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study adds cardiac PET/MRI imaging to the cerebral amyloid PET scans that patients are already having to clarify Alzheimer's disease. Participants also receive an echocardiogram (heart ultrasound), a 12‑lead ECG, and a clinical dementia assessment. Researchers follow participants for about one year to record how often heart amyloid deposits occur and how they relate to heart function and disease stage.
What it is studying. The study is testing whether amyloid deposits can be detected in the heart of people who are being evaluated with cerebral amyloid PET, and whether presence of cardiac amyloid is associated with measures of heart dysfunction or with different clinical stages of Alzheimer's disease.
What the researchers hope to learn. To determine how often cardiac amyloid deposits occur in people evaluated for Alzheimer's disease and to examine their relationship to heart function and clinical disease stage. Results aim to inform diagnostic understanding of cardiac amyloidosis and Alzheimer's disease.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This study seeks to explore the possible common pathogenesis of both cardiac amyloidosis and Alzheimer's disease, which can both be associated with amyloid deposits. Using Positron Emission Tomography (PET) scans with amyloid tracers - a conventional tool for non-invasively imaging amyloid deposits in Alzheimer's disease - the research will extend this imaging methodology to the heart. The study will conduct additional PET/MRI scans of the heart in patients undergoing amyloid tracer PET scans for Alzheimer's evaluations. Each participant will also undergo an echocardiogram and a clinical examination of dementia. This could potentially enhance diagnostic practices in both cardiac amyloidosis and Alzheimer's disease.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patients undergoing cerebral amyloid PET examination for clinical indication to clarify Alzheimer's disease
- No contraindications to undergo an MRI examination
- No contraindications to undergo an Amyloid PET scan
Exclusion criteria
- Patients with vascular dementia and confirmed other causes of dementia (e.g. stroke, vitamin deficiency, thyroid insufficiency, toxic causes such as alcohol)
- Patients with pronounced cardiac preconditions
- Pregnant and breastfeeding women
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will have their planned cerebral amyloid PET extended to include cardiac PET/MRI imaging; the record states no additional tracer is given and no extra radiation exposure occurs. They will also receive a transthoracic echocardiogram including strain analysis, a 12‑lead electrocardiogram (ECG), and a clinical dementia examination. A companion is expected to attend with the participant for study visits. The record does not specify exact visit numbers, timing, or other routine tests.
How the study is structured. A prospective observational cohort study: people referred for cerebral amyloid PET have the amyloid imaging extended to include cardiac PET/MRI, plus an echocardiogram and ECG. Researchers record presence of cardiac amyloid and compare it with heart function and clinical dementia assessments over roughly one year.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Dementia, Alzheimer Type; Mild Cognitive Impairment; Cardiac Amyloidosis. Does it apply to my diagnosis?
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
This trial is also listed on this site under ATTRv amyloidosis.
Important dates
- Study start
- Aug 15, 2022
- Primary completion
- Aug 14, 2023
- Study completion
- Sep 14, 2025 (estimated)
- Target enrollment
- 15 participants (estimated)
- Last updated on registry
- Sep 4, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University Hospital, Essen
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- David Kersting, MD PhD 📞 +49-201-723-2073 ✉ david.kersting@uk-essen.de
- Stephan Settelmeier, MD
Participating sites (1)
- University Hospital EssenRecruiting
Essen, North Rhine-Westphalia, 45147 · Germany
- David Kersting, MD PhD · +49-201-723-2073 · david.kersting@uk-essen.de
Terms used on this page · explanations by MedicalUpdates.ai
- Positron Emission Tomography
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- echocardiogram
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- contraindications
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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