NCT04427436

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

May 14, 2020

Last Update Submit

June 10, 2020

Conditions

Alzheimer Disease, Early Onset

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

Patients

Mild Cognitive Impairment (clinical determination)

Other: No Intervention

Control

Healthy Elderly

Other: No Intervention

Interventions

No InterventionOTHER

No Intervention

ControlPatients

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Clinically diagnosed MCI patients and matched healthy controls

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34035103DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. Notger Müller

Study Record Dates

First Submitted

May 14, 2020

First Posted

June 11, 2020

Study Start

July 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

June 11, 2020

Record last verified: 2020-06