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Novel Dementia Biomarkers

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04427436
Enrollment
100
Registered
2020-06-11
Start date
2020-07-01
Completion date
2021-12-31
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Early Onset

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.

Interventions

OTHERNo Intervention

No Intervention

Sponsors

Otto-von-Guericke University Magdeburg
CollaboratorOTHER
German Center for Neurodegenerative Diseases (DZNE)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Locus Coeruleus (LC) Intensity15 minutesLC-intensity can be assesed with specific MRI sequences (TSE MRI-Sequence (see Dordevic et al, 2017))
Volume of brain regions30 minutesVBM (voxel-based morphometry)
fNIRS-based change in oxyhemoglobin and deoxyhemoglobin1 hourIn 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.
Event-related-potential (ERP) waveforms: negative deflections (N100, N300) and positive deflections (P100, P300)1 hourVoltages generated in the brain structures in response to specific events (Event-related potentials (ERPs))
Heart Rate Variability (HRV)1 hourECG-based variability measures in R-R intervals, both in rest abd during tasks
Score on CERAD-Plus30 minutesCognitive performance measure in points, with a higher score meaning better performance
Error-rate on Stroop-test10 minutesTest of executive functions, higher error-rate means worse performance
Error-rate on N-Back-test10 minutesWorking memory test, higher error-rate means worse performance
Performance on verbal fluency test10 minutesTest of verbal fluency, more words spoken means a better score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026