Cardiac Amyloid Deposits and Heart Dysfunction in Alzheimer's Disease

NCT07154394 | Recruiting

• 1 other identifier: 20-9291-BO
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dementia, Alzheimer Type; Mild Cognitive Impairment; Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Heredodegenerative Disorders, Nervous System; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Central Study Contacts

David Kersting, MD PhD

CONTACT

+49-201-723-2073; david.kersting@uk-essen.de

Stephan Settelmeier, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: September 4, 2025
• Study Start: August 15, 2022
• Primary Completion: August 14, 2023
• Study Completion: September 14, 2025
• Last Updated: September 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)