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Clinical Trials/NCT04427436
NCT04427436
Unknown
N/A

Investigating the Potential of Novel Dementia Biomarkers - an MRI, fNIRS and EEG Study

German Center for Neurodegenerative Diseases (DZNE)0 sites100 target enrollmentJuly 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer Disease, Early Onset
Sponsor
German Center for Neurodegenerative Diseases (DZNE)
Enrollment
100
Primary Endpoint
Performance on verbal fluency test
Last Updated
5 years ago

Overview

Brief Summary

The study will investigate structural and functional characteristics of the brain of dementia patients compared to healthy controls in order to get a better insight into importance of early biomarkers for the diagnosis of Alzheimer's dementia. The methods for obtaining biomarkers incude magnetic resonance imaging (MRI), near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), electrocardiography (ECG) and neurophyshological assessments. Special parameters are being studied that have already been shown to detect changes in the early stages of Alzheimer's dementia.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
German Center for Neurodegenerative Diseases (DZNE)
Responsible Party
Principal Investigator
Principal Investigator

Notger Müller

Professor Dr. Notger Müller

German Center for Neurodegenerative Diseases (DZNE)

Eligibility Criteria

Inclusion Criteria

  • Clinically diagnosed MCI patients and matched healthy controls

Exclusion Criteria

  • Metal in body and tatoos;
  • Other chronic systemic neurological, cardiologic, metabolic or musculo-skeletal diseases which have been proven to influence the outcome variables
  • Alcohol abuse
  • Colour blindness
  • Pregnancy
  • Surgery in the last 6 months
  • Uncorrected vision

Outcomes

Primary Outcomes

Performance on verbal fluency test

Time Frame: 10 minutes

Test of verbal fluency, more words spoken means a better score

Heart Rate Variability (HRV)

Time Frame: 1 hour

ECG-based variability measures in R-R intervals, both in rest abd during tasks

Locus Coeruleus (LC) Intensity

Time Frame: 15 minutes

LC-intensity can be assesed with specific MRI sequences (TSE MRI-Sequence (see Dordevic et al, 2017))

Error-rate on Stroop-test

Time Frame: 10 minutes

Test of executive functions, higher error-rate means worse performance

Event-related-potential (ERP) waveforms: negative deflections (N100, N300) and positive deflections (P100, P300)

Time Frame: 1 hour

Voltages generated in the brain structures in response to specific events (Event-related potentials (ERPs))

Volume of brain regions

Time Frame: 30 minutes

VBM (voxel-based morphometry)

fNIRS-based change in oxyhemoglobin and deoxyhemoglobin

Time Frame: 1 hour

In response to each task there is a hemodynamic response, which can be measured by fNIRS. In particular, fNIRS measures changes in blood oxy- and deoxy-hemoglobin.

Score on CERAD-Plus

Time Frame: 30 minutes

Cognitive performance measure in points, with a higher score meaning better performance

Error-rate on N-Back-test

Time Frame: 10 minutes

Working memory test, higher error-rate means worse performance

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