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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

Tracking Information
First Submitted Date April 19, 2016
First Posted Date April 27, 2016
Last Update Posted Date August 14, 2019
Study Start Date May 2016
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 22, 2016)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02752750 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Longitudinal Quantitative Susceptibility Mapping (QSM) in Alzheimer 's Disease
Official Title Longitudinal Quantitative Susceptibility Mapping (QSM) in Alzheimer 's Disease
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Alzheimer 's Disease
Condition Alzheimer's Disease
Intervention Other: MRI
MR imaging (MRI) at 3 Tesla
Other Name: Magnetic resonance imaging
Study Groups/Cohorts
  • AD_GROUP
    Patients with Alzheimer's disease
    Intervention: Other: MRI
  • HC_GROUP
    Healthy controls
    Intervention: Other: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: April 22, 2016)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02752750
Other Study ID Numbers QSM AD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Medical University of Graz
Study Sponsor Medical University of Graz
Collaborators Not Provided
Investigators
Principal Investigator: Christian Langkammer, PhD Medical University of Graz
PRS Account Medical University of Graz
Verification Date August 2019