Mild Cognitive ImpairmentNCT04387357
Multimodal Imaging in the Study of Disorientation in the Hospital
An observational study of Mild Cognitive Impairment and Dementia, run by University Medical Center Rostock at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Dementia, Disorientation
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy older adults and older adults with mild cognitive impairment or dementia
Who may be able to join
- 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
Who cannot join
- Less than 50 years
- Significantly impaired vision or hearing
- Severely reduced mobility: cannot move around independently (even with aids)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Clinic and Polyclinic for Psychosomatics and Psychotherapeutic Medicine, University Medical Center Rostock
Rostock, Mecklenburg-Vorpommern, 18147
Stefan J. Teipel, Prof. Dr., 0049-381-494-9471, stefan.teipel@med.uni-rostock.de
Stefan J. Teipel, Prof. Dr.
About this study
Official title: Multimodal Imaging in Alzheimer's Disease and Other Neurodegenerative Diseases
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Dementia, Disorientation, Older Adults, Magnetic Resonance Imaging
- Medical subject headings
- Cognitive Dysfunction, Dementia, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Neurologically healthy older adults above the age of 50 | |
| Experimental | Older adults above the age of 50 with Mild Cognitive Impairment or Dementia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial disorientation
Incidences of disorientation will be annotated in real-time using a customized annotation scheme in the pocket observer software
Measured: Up to 3 years from start of the study
Secondary outcomes (7)
Heart rate variability
Rate of change in heart rate will be measured using a wearable Photoplethysmography sensor
Measured: Up to 3 years from start of the study
Skin conductance
Rate of change in electrodermal response will be measured using a wearable electrodermal activity sensor
Measured: Up to 3 years from start of the study
Accelerometry
Incidences of change in movement behaviour and activity level will be measured using accelerometers
Measured: Up to 3 years from start of the study
Grey matter volume
Rate of change in brain structural volume will be measured using a 3-Tesla scanner
Measured: Up to 3 years from start of the study
White matter integrity
Rate of change in structural connectivity of brain white matter will be measured using a 3-Tesla scanner
Measured: Up to 3 years from start of the study
Resting-state functional connectivity
Rate of change in functional connectivity of resting-state brain networks will be measured using a 3-Tesla scanner
Measured: Up to 3 years from start of the study
Interview responses
Participants assessments of their sense of orientation are obtained using a structured interview.
Measured: Up to 3 years from start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Oct 2019
- Primary completionJun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Neurodegenerative Diseases (DZNE)
- Responsible party
- Principal investigator, Stefan Teipel, University Medical Center Rostock
- Investigators
- Stefan J. Teipel, Prof. Dr., Principal investigator, University Medical Center Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387357
- Sponsor's protocol ID
- A-2012-0083
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31362286Ranasinghe 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.
PubMed 25180158
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging in Alzheimer's Disease and Other Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT04387357
- Acronym / sponsor ID
- A-2012-0083
- Conditions
- Mild Cognitive Impairment, Dementia, Disorientation, Older Adults, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center RostockUniversity, hospital or other
- Collaborators
- German Center for Neurodegenerative Diseases (DZNE)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Neurologically healthy older adults above the age of 50 |
| Experimental | – | –Older adults above the age of 50 with Mild Cognitive Impairment or Dementia |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy older adults and older adults with mild cognitive impairment or dementia
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Less than 50 years
- Significantly impaired vision or hearing
- Severely reduced mobility: cannot move around independently (even with aids)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Heart rate variability
Time frame: Up to 3 years from start of the study
Skin conductance
Time frame: Up to 3 years from start of the study
Accelerometry
Time frame: Up to 3 years from start of the study
Grey matter volume
Time frame: Up to 3 years from start of the study
White matter integrity
Time frame: Up to 3 years from start of the study
Resting-state functional connectivity
Time frame: Up to 3 years from start of the study
Interview responses
Time frame: Up to 3 years from start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Background: PubMed 31362286Schaat 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.
- Background: PubMed 25180158Ranasinghe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan J. Teipel, Prof. Dr. principal investigator
University Medical Center Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Dementia, run by University Medical Center Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chimezie O Amaefule, M.Sc (0049-381-494-9478, chimezie.amaefule@dzne.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial disorientation (time frame: Up to 3 years from start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04387357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.