Longitudinal Quantitative Susceptibility Mapping (QSM) in Alzheimer 's Disease

NCT ID: NCT02752750

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2025-05-31

Brief Summary

In this explorative longitudinal study 50 patients with Alzheimer's disease (AD) and 50 age-matched control subjects will be recruited for their 2 years follow-ups and undergo extensive cognitive testing and quantitative 3 Tesla magnetic resonance imaging (MRI). Regional differences of susceptibility and R2* relaxation rates in deep gray matter and the neocortex will be evaluated in AD patients and controls and related to the patients´ cognitive status at baseline.

Detailed Description

Abnormally increased brain iron accumulation in deep gray matter is a common finding in Alzheimer's disease (AD) and amyloid protein precursor and tau proteins were linked to disrupted iron homeostasis. Validation studies showed that brain iron can be measured precisely by the novel magnetic resonance imaging (MRI) technique quantitative susceptibility mapping (QSM) in vivo, thus, enabling reliable and precise longitudinal investigations.

It is hypothesized that pathologic brain iron accumulation can be assessed with higher sensitivity with QSM than with current MRI techniques such as R2* relaxation rate mapping and that regional QSM is a predictor for cognitive decline and disability.

This explorative longitudinal study is including 50 patients with AD and age-matched control subjects which will be recruited for their 2 years follow-ups and undergo extensive cognitive testing and quantitative 3 Tesla MRI. Regional differences of susceptibility and R2* in deep gray matter and the neocortex will be evaluated in AD patients and controls and related to the patients´ cognitive status at baseline. Follow-up MRI and clinical data with multivariate regression analysis serve to investigate the dynamics of AD-related changes of susceptibility, and their relation to cognitive functioning.

In conclusion, this explorative longitudinal study in a patient cohort aims to clarify whether regional QSM changes are potential biomarkers for AD progression.

Conditions

Alzheimer's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AD_GROUP

Patients with Alzheimer's disease

MRI

Intervention Type: OTHER

MR imaging (MRI) at 3 Tesla

HC_GROUP

Healthy controls

MRI

Intervention Type: OTHER

MR imaging (MRI) at 3 Tesla

Interventions

MRI

MR imaging (MRI) at 3 Tesla

Intervention Type: OTHER

Other Intervention Names

Magnetic resonance imaging

Eligibility Criteria

Inclusion Criteria

• diagnosis of dementia according to DSM-IV and NINCDS-ADRDA criteria
• the patient lives either with the family or has less than 40h/week of external care
• the patients is able to understand the role in this study and is willing to participate
• the physician in charge of this study confirms that the patients understands the study and its aims according to cognitive and clinical testing

Exclusion Criteria

• are other disorders
• participation in a clinical drug trial (phase 1-3)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Langkammer, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Other Identifiers

QSM AD

Identifier Type: -

Identifier Source: org_study_id