Cardiac Amyloid Deposits and Heart Dysfunction in Alzheimer's Disease

NCT ID: NCT07154394

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-15

Study Completion Date

2025-09-14

Brief Summary

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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.

Detailed Description

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Conditions

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Dementia, Alzheimer Type Mild Cognitive Impairment Cardiac Amyloidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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David Kersting, MD PhD

Role: CONTACT

+49-201-723-2073

Stephan Settelmeier, MD

Role: CONTACT

Facility Contacts

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David Kersting, MD PhD

Role: primary

+49-201-723-2073

Other Identifiers

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20-9291-BO

Identifier Type: -

Identifier Source: org_study_id

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