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

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ClinicalTrials.gov Identifier: NCT02752750
Recruitment Status : Enrolling by invitation
First Posted : April 27, 2016
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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
Alzheimer's Disease 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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Quantitative Susceptibility Mapping (QSM) in Alzheimer 's Disease
Study Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
AD_GROUP
Patients with Alzheimer's disease
Other: MRI
MR imaging (MRI) at 3 Tesla
Other Name: Magnetic resonance imaging

HC_GROUP
Healthy controls
Other: MRI
MR imaging (MRI) at 3 Tesla
Other Name: Magnetic resonance imaging




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Alzheimer 's Disease
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752750


Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Christian Langkammer, PhD Medical University of Graz

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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02752750     History of Changes
Other Study ID Numbers: QSM AD
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders