Novel Dementia Biomarkers

• Conditions: Alzheimer Disease, Early Onset
• Interventions: Other: No Intervention

• Registration Number: NCT04427436
• Lead Sponsor: German Center for Neurodegenerative Diseases (DZNE)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-14
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-10
• Last Update Submitted: 2020-06-10
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11
• Study Start: 2020-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	No Intervention	Healthy Elderly
Patients	No Intervention	Mild Cognitive Impairment (clinical determination)

Primary Outcome Measures

Name	Time	Method
Performance on verbal fluency test	10 minutes	Test of verbal fluency, more words spoken means a better score
Heart Rate Variability (HRV)	1 hour	ECG-based variability measures in R-R intervals, both in rest abd during tasks
Locus Coeruleus (LC) Intensity	15 minutes	LC-intensity can be assesed with specific MRI sequences (TSE MRI-Sequence (see Dordevic et al, 2017))
Error-rate on Stroop-test	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)	1 hour	Voltages generated in the brain structures in response to specific events (Event-related potentials (ERPs))
Volume of brain regions	30 minutes	VBM (voxel-based morphometry)
fNIRS-based change in oxyhemoglobin and deoxyhemoglobin	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	30 minutes	Cognitive performance measure in points, with a higher score meaning better performance
Error-rate on N-Back-test	10 minutes	Working memory test, higher error-rate means worse performance