NCT04387357

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

May 7, 2020

Last Update Submit

May 12, 2020

Conditions

Mild Cognitive ImpairmentDementiaDisorientationOlder AdultsMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Spatial disorientation

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

    Up to 3 years from start of the study

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Control

Neurologically healthy older adults above the age of 50

Experimental

Older adults above the age of 50 with Mild Cognitive Impairment or Dementia

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy older adults and older adults with mild cognitive impairment or dementia

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock

Rostock, Mecklenburg-Vorpommern, 18147, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31362286BACKGROUND

  • 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.

    PMID: 25180158BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionDementiaConfusion

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan J. Teipel, Prof. Dr.

    University Medical Center Rostock

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chimezie O Amaefule, M.Sc

CONTACT

0049-381-494-9478chimezie.amaefule@dzne.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 13, 2020

Study Start

October 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 30, 2021

Last Updated

May 13, 2020

Record last verified: 2020-05

Locations

DE(1)