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

Sponsor
Medical University of Graz (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02752750
Collaborator
(none)
50
84

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MRI

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Longitudinal Quantitative Susceptibility Mapping (QSM) in Alzheimer 's Disease
Study Start Date :
May 1, 2016
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Quantitative magnetic susceptibility (QSM) in the human brain [2 years]

      Reveal the dynamics of disease related brain iron deposition (by QSM in ppm) and its relation to disease progression and cognition.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT02752750
    Other Study ID Numbers:
    • QSM AD
    First Posted:
    Apr 27, 2016
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022