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

September 18, 2023 updated by: Medical University of Graz
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Alzheimer 's Disease

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AD_GROUP
Patients with Alzheimer's disease
Other: MRI
MR imaging (MRI) at 3 Tesla
Other Names:
  • Magnetic resonance imaging
HC_GROUP
Healthy controls
Other: MRI
MR imaging (MRI) at 3 Tesla
Other Names:
  • Magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative magnetic susceptibility (QSM) in the human brain
Time Frame: 2 years
Reveal the dynamics of disease related brain iron deposition (by QSM in ppm) and its relation to disease progression and cognition.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Christian Langkammer, PhD, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimated)

April 27, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QSM AD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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