Novel Dementia Biomarkers

Alzheimer Disease, Early Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04427436
• Other study ID #: MD070
• Status: Not yet recruiting
• Start date: July 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: German Center for Neurodegenerative Diseases (DZNE)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset
• Dementia

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
German Center for Neurodegenerative Diseases (DZNE)	Otto-von-Guericke University Magdeburg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locus Coeruleus (LC) Intensity	LC-intensity can be assesed with specific MRI sequences (TSE MRI-Sequence (see Dordevic et al, 2017))	15 minutes
Primary	Volume of brain regions	VBM (voxel-based morphometry)	30 minutes
Primary	fNIRS-based change in oxyhemoglobin and deoxyhemoglobin	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.	1 hour
Primary	Event-related-potential (ERP) waveforms: negative deflections (N100, N300) and positive deflections (P100, P300)	Voltages generated in the brain structures in response to specific events (Event-related potentials (ERPs))	1 hour
Primary	Heart Rate Variability (HRV)	ECG-based variability measures in R-R intervals, both in rest abd during tasks	1 hour
Primary	Score on CERAD-Plus	Cognitive performance measure in points, with a higher score meaning better performance	30 minutes
Primary	Error-rate on Stroop-test	Test of executive functions, higher error-rate means worse performance	10 minutes
Primary	Error-rate on N-Back-test	Working memory test, higher error-rate means worse performance	10 minutes
Primary	Performance on verbal fluency test	Test of verbal fluency, more words spoken means a better score	10 minutes