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Clinical Trials/NCT04387357
NCT04387357
Unknown
Not Applicable

Multimodal Imaging in Alzheimer's Disease and Other Neurodegenerative Diseases

University Medical Center Rostock1 site in 1 country50 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
University Medical Center Rostock
Enrollment
50
Locations
1
Primary Endpoint
Spatial disorientation
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to investigate whether markers of brain structure and function from MRI are associated with different levels of spatial orientation and gait parameters in people with mild cognitive impairment or dementia due to Alzheimer's disease when walking through a real world environment.

Detailed Description

This is an experimental cross-sectional study which primarily aims at identifying characteristic features of spatial disorientation among people with mild cognitive impairment and dementia. The features of interest are motion and physiological related changes that occur during instances of spatial disorientation, which will be derived from wearable sensors. Additionally, brain structure and functional connectivity changes associated with different levels of spatial orientation and gait parameters will also be investigated through resting-state functional imaging.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
June 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Medical Center Rostock
Responsible Party
Principal Investigator
Principal Investigator

Stefan Teipel

Prof. Dr. med

University Medical Center Rostock

Eligibility Criteria

Inclusion Criteria

  • 50 years and above
  • Mini mental state examination (MMSE) ≥ 12 \< 28 points for experimental group
  • Mini mental state examination (MMSE) ≥ 28 points for control group
  • Sufficient knowledge of German to understand participant information, declaration of consent and questionnaires
  • Dated and signed declaration of consent
  • Sufficient mobility and motivation to participate in the study

Exclusion Criteria

  • Less than 50 years
  • Significantly impaired vision or hearing
  • Severely reduced mobility: cannot move around independently (even with aids)

Outcomes

Primary Outcomes

Spatial disorientation

Time Frame: Up to 3 years from start of the study

Incidences of disorientation will be annotated in real-time using a customized annotation scheme in the pocket observer software

Secondary Outcomes

  • Heart rate variability(Up to 3 years from start of the study)
  • Skin conductance(Up to 3 years from start of the study)
  • Accelerometry(Up to 3 years from start of the study)
  • Grey matter volume(Up to 3 years from start of the study)
  • White matter integrity(Up to 3 years from start of the study)
  • Resting-state functional connectivity(Up to 3 years from start of the study)
  • Interview responses(Up to 3 years from start of the study)

Study Sites (1)

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