Clinical trial NCT02752750: Longitudinal Quantitative Susceptibility Mapping (QSM) in Alzheimer 's Disease
Official title: Longitudinal Quantitative Susceptibility Mapping (QSM) in Alzheimer 's Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Alzheimer's Disease
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with 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.

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)

Primary outcomes:
measure: Quantitative magnetic susceptibility (QSM) in the human brain
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Graz
name: Christian Langkammer, PhD
role: PRINCIPAL_INVESTIGATOR
References: