Novel Dementia Biomarkers

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

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.

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease, Early Onset
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 50 and 80 years will be recruited from the memory clinic at the Department of Neurology of the Otto von Guericke University Clinic, Magdeburg, Germany. The diagnosis of MCI/AD will be established by experienced neurologists of the memory clinic according to standardised criteria. Control participants will be matched by education, age and gender. These will be recruited through advertisement.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Mild Cognitive Impairment (clinical determination)	Other: No Intervention; No Intervention
Control; Healthy Elderly	Other: No Intervention; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locus Coeruleus (LC) Intensity	LC-intensity can be assesed with specific MRI sequences (TSE MRI-Sequence (see Dordevic et al, 2017))	15 minutes
Volume of brain regions	VBM (voxel-based morphometry)	30 minutes
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
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
Heart Rate Variability (HRV)	ECG-based variability measures in R-R intervals, both in rest abd during tasks	1 hour
Score on CERAD-Plus	Cognitive performance measure in points, with a higher score meaning better performance	30 minutes
Error-rate on Stroop-test	Test of executive functions, higher error-rate means worse performance	10 minutes
Error-rate on N-Back-test	Working memory test, higher error-rate means worse performance	10 minutes
Performance on verbal fluency test	Test of verbal fluency, more words spoken means a better score	10 minutes

Collaborators and Investigators

• Sponsor: German Center for Neurodegenerative Diseases (DZNE)
• Collaborators: Otto-von-Guericke University Magdeburg

Publications and helpful links

General Publications

• Grassler B, Herold F, Dordevic M, Gujar TA, Darius S, Bockelmann I, Muller NG, Hokelmann A. Multimodal measurement approach to identify individuals with mild cognitive impairment: study protocol for a cross-sectional trial. BMJ Open. 2021 May 25;11(5):e046879. doi: 10.1136/bmjopen-2020-046879.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: MD070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No