Dementia, Alzheimer TypeNCT07154394
Cardiac Amyloid Deposits and Heart Dysfunction in Alzheimer's Disease
An observational study of Dementia, Alzheimer Type and Mild Cognitive Impairment, run by University Hospital, Essen at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Alzheimer Type, Mild Cognitive Impairment, Cardiac Amyloidosis
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2022to 14 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients who have been clinically referred for a cerebral amyloid PET examination to clarify a diagnosis of Alzheimer's disease. The study aims to recruit a diverse group of patients, aged 50-90 years, with a minimum of 7 years of education and good knowledge of the German language. Patients will be accompanied by a companion during the study. Excluded from the study will be patients with vascular dementia or other confirmed causes of dementia, such as stroke, vitamin deficiency, thyroid insufficiency, or toxic causes like alcohol. Additionally, patients with pronounced cardiac preconditions, pregnant women, and breastfeeding women will be excluded. The study population will be recruited from a clinical setting, where patients are undergoing routine diagnostic tests for Alzheimer's disease.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stephan Settelmeier, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Essen
Essen, North Rhine-Westphalia, 45147
David Kersting, MD PhD, +49-201-723-2073, david.kersting@uk-essen.de
About this study
Official title: 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)
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.
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for cerebral amyloid PET to clarify Alzheimer's disease | The study population consists of patients who have been clinically referred for a cerebral amyloid PET examination to clarify a diagnosis of Alzheimer's disease. The study population will undergo a comprehensive diagnostic evaluation, which includes: * An extension of the amyloid PET examination to include cardiac PET/MRI imaging. No additional substances are applied and there is no additional radiation exposure. * A transthoracic echocardiogram, including strain analysis * A 12-lead electrocardiogram (EKG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of occurrence of cardiac amyloid deposits in patients with a diagnosis of Alzheimer's disease (overall)
Measured: through study completion, an average of 1 year
Frequency of occurrence of cardiac amyloid deposits in relation to different disease manifestations (subdivided, for example, by clinical assessment of disease stage)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start15 Aug 2022
- Primary completion14 Aug 2023
- Study completion14 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, Alzheimer TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154394
- Sponsor's protocol ID
- 20-9291-BO
- Status last verified
- Dec 2024
- First submitted
- 20 May 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07154394
- Acronym / sponsor ID
- 20-9291-BO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Sep 2025 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred for cerebral amyloid PET to clarify Alzheimer's disease | – | –The study population consists of patients who have been clinically referred for a cerebral amyloid PET examination to clarify a diagnosis of Alzheimer's disease. The study population will undergo a comprehensive diagnostic evaluation, which includes: * An extension of the amyloid PET examination to include cardiac PET/MRI imaging. No additional substances are applied and there is no additional radiation exposure. * A transthoracic echocardiogram, including strain analysis * A 12-lead electrocardiogram (EKG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients who have been clinically referred for a cerebral amyloid PET examination to clarify a diagnosis of Alzheimer's disease. The study aims to recruit a diverse group of patients, aged 50-90 years, with a minimum of 7 years of education and good knowledge of the German language. Patients will be accompanied by a companion during the study. Excluded from the study will be patients with vascular dementia or other confirmed causes of dementia, such as stroke, vitamin deficiency, thyroid insufficiency, or toxic causes like alcohol. Additionally, patients with pronounced cardiac preconditions, pregnant women, and breastfeeding women will be excluded. The study population will be recruited from a clinical setting, where patients are undergoing routine diagnostic tests for Alzheimer's disease.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of occurrence of cardiac amyloid deposits in patients with a diagnosis of Alzheimer's disease (overall)
Time frame: through study completion, an average of 1 year
Frequency of occurrence of cardiac amyloid deposits in relation to different disease manifestations (subdivided, for example, by clinical assessment of disease stage)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephan Settelmeier, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, Alzheimer Type and Mild Cognitive Impairment, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Kersting, MD PhD (+49-201-723-2073, david.kersting@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of occurrence of cardiac amyloid deposits in patients with a diagnosis of Alzheimer's disease (overall) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.