Clinical trial NCT04387357: Multimodal Imaging in the Study of Disorientation in the Hospital
Official title: Multimodal Imaging in Alzheimer's Disease and Other Neurodegenerative Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Dementia
Disorientation
Older Adults
Magnetic Resonance Imaging
Lead sponsor: University of Rostock
Sponsor class: OTHER
Collaborators: name: German Center for Neurodegenerative Diseases (DZNE)
First posted: 2020-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy older adults and older adults with mild cognitive impairment or dementia

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.

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)

Primary outcomes:
measure: Spatial disorientation
timeFrame: Up to 3 years from start of the study
Secondary outcomes:
measure: Heart rate variability
timeFrame: Up to 3 years from start of the study
measure: Skin conductance
timeFrame: Up to 3 years from start of the study
measure: Accelerometry
timeFrame: Up to 3 years from start of the study
measure: Grey matter volume
timeFrame: Up to 3 years from start of the study
measure: White matter integrity
timeFrame: Up to 3 years from start of the study
measure: Resting-state functional connectivity
timeFrame: Up to 3 years from start of the study
measure: Interview responses
timeFrame: Up to 3 years from start of the study
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock
state: Mecklenburg-Western Pomerania
Study officials:
affiliation: University Medical Center Rostock
name: Stefan J. Teipel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schaat S, Koldrack P, Yordanova K, Kirste T, Teipel S. Real-Time Detection of Spatial Disorientation in Persons with Mild Cognitive Impairment and Dementia. Gerontology. 2020;66(1):85-94. doi: 10.1159/000500971. Epub 2019 Jul 30.
citation: Ranasinghe KG, Hinkley LB, Beagle AJ, Mizuiri D, Dowling AF, Honma SM, Finucane MM, Scherling C, Miller BL, Nagarajan SS, Vossel KA. Regional functional connectivity predicts distinct cognitive impairments in Alzheimer's disease spectrum. Neuroimage Clin. 2014 Jul 23;5:385-95. doi: 10.1016/j.nicl.2014.07.006. eCollection 2014.