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)

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 Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Dementia, Alzheimer Type; Cardiac Amyloidosis

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: David Kersting, MD PhD; Phone Number: +49-201-723-2073; Email: david.kersting@uk-essen.de
• Study Contact Backup: Name: Stephan Settelmeier, MD

Study Locations

• Germany
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45147
      • Recruiting
      • University Hospital Essen
      • Contact: David Kersting, MD PhD; Phone Number: +49-201-723-2073; Email: david.kersting@uk-essen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of occurrence of cardiac amyloid deposits in patients with a diagnosis of Alzheimer's disease (overall)	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)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Essen

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): August 14, 2023
• Study Completion (Estimated): September 14, 2025

Study Registration Dates

• First Submitted: May 20, 2025
• First Submitted That Met QC Criteria: August 26, 2025
• First Posted (Estimated): September 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neuromuscular Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Peripheral Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Proteostasis Deficiencies; Amyloid Neuropathies; Amyloidosis, Familial; Amyloidosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Cognitive Dysfunction; Alzheimer Disease; Amyloid Neuropathies, Familial
• Other Study ID Numbers: 20-9291-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No