Mild Cognitive ImpairmentNCT04262674
Non-invasive, Wearable Multi-parameter System for the Early Prediction of Cognitive Decline and Dementia in Older Adults
A study testing Cognitive-motor training in people with Mild Cognitive Impairment and Healthy Aging, run by Empa, Swiss Federal Laboratories for Materials Science and Technology at 1 site in Switzerland.
Trial summary
This project develops an innovative screening system and prediction model to detect preclinical symptoms of cognitive impairment and predict the potential development of mild cognitive impairments and dementia in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Healthy Aging
- What is being tested?
- Cognitive-motor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Sep 2019to Jul 2021
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- participants have to be older than 65 years of age
- cognitively healthy or diagnosed with MCI
- able to walk at least 8 minutes for gait analysis, with or without walking aids
- live independently or in a retirement home (classified 0, 1, or 2 within the Swiss classification system for health-care requirements BESA-levels [German abbreviation for: Bewohner-Einstufungs- und Abrechnungs-System; level 0 meaning the person does not need care or treatment; level 1 to 2 meaning, the person only needs little care or treatment])
- sign informed consent
Who cannot join
- previously diagnosed dementia, e.g. Alzheimer's disease
- recent head injury
- judgment by the participant's primary care physician will be required in the case of acute or instable chronic diseases (e.g. stroke, diabetes) and rapidly progressing or terminal illnesses
- Additional exclusion criteria for the subgroup of 15 participants who would agree to take the telemetric gastrointestinal temperature pill:
- history of operations and/or disease related to the gastrointestinal tract within last 5 years
- implanted medical device
- planned MRI examination
- nausea, vomiting, constipation or abdominal pain within 1 months prior to the day of planned measurement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Innovative, Non-invasive, Wearable Multi-parameter System for the Early Prediction of Cognitive Decline and Dementia in Older Adults
This project develops an innovative screening system and prediction model to detect preclinical symptoms of cognitive impairment and predict the potential development of mild cognitive impairments and dementia in older adults. The earliest possible detection of preclinical symptoms is prerequisite to improve the efficacy of subsequent preventative non-pharmacological, life-style and exercise related, personalized treatment interventions.
Read the detailed description
BACKGROUND: Early detection of preclinical symptoms and prediction of potential development of mild cognitive impairment (MCI) and Alzheimer's disease (AD) could improve non-pharmacologic, life-style and exercise related preventative interventions' efficacy and slow-down disease progression. To achieve this goal, discriminating the earliest preclinical stage of MCI/AD from healthy state would be necessary. However, this is still challenging and current clinical methods are not feasible for preventative screening in larger populations of older adults, as they involve invasive sampling of molecular blood or cerebrospinal fluid biomarkers, as well as expensive brain imaging and extensive neuropsychological testing. Recently, several non-invasive alternative measures, including electroencephalography (EEG), gait analysis, heart rate variability (HRV), and core body temperature (Tc), were shown to be associated with preclinical symptoms of MCI/AD and to predict disease progression.
AIM: The investigators aim to combine these measures in a novel non-invasive multi-parameter prediction model, which better reflects multimodal symptomatology compared to currently used methods and, therefore, allows discriminating healthy persons from MCI state with adequate sensitivity (i.e. >80%).
METHODS: A cohort of 85 older adults, ≥65 years of age, including healthy persons and patients with MCI, will be recruited. Assessments will be performed at baseline, after 2 months (within these two 2 months one group will follow a cognitive-motor training intervention, while the other serves as passive control), and at 12-month follow-up. Assessments include EEG, gait analysis, HRV, and Tc at rest and during walking, and will be compared to reference measures of MCI status, including neuropsychological tests, to develop the prediction model and evaluate its sensitivity.
- Conditions
- Mild Cognitive Impairment, Healthy Aging
- Being tested
- Cognitive-motor training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-motor trainingOther
Also called Exergame, Step Mania
Simultaneous cognitive-motor training and strength training
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-motor training | Experimental | Simultaneous cognitive-motor training (i.e. exergame) and strength training Receives: Other: Cognitive-motor training |
| Control | No intervention | Passive control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography (EEG)
EEG frequency bands (Hz) will be assessed during 10 minutes at rest in a seated position (5 min eyes closed, 5 min eyes open) and will be recorded using a wearable system covering the frontal, parietal, temporal, and occipital cortex and integrating 20 gel-pad electrode channels. The assessment will be continued during the subsequent gait protocol which consists of 8 minutes of walking back and forth at preferred speed on a 20 m track.
Measured: 30 minutes
Gait speed analysis with inertial sensors
The gait protocol consists of 8 minutes of walking back and forth at preferred speed on a 20 m track. Thereby, walking speed (m/s) will be assessed using inertial sensors attached to the feet.
Measured: 15 minutes
Gait variability analysis with inertial sensors
The gait protocol consists of 8 minutes of walking back and forth at preferred speed on a 20 m track. Thereby, step length variability (%) and step time variability (%) will be assessed using inertial sensors attached to the feet.
Measured: 15 minutes
Heart rate variability (HRV) indices SDNN and RMSSD with two-lead electrocardiogram chest belt
The HRV indices SDNN (ms) and RMSSD (ms) will be assessed during 10 minutes in a seated position, using a two-lead electrocardiogram chest belt.
Measured: 10 minutes
Heart rate variability (HRV) index HF power with two-lead electrocardiogram chest belt
The HRV index HF power (ms^2) will be assessed during 10 minutes in a seated position, using a two-lead electrocardiogram chest belt.
Measured: 10 minutes
Body temperature (T) with temperature sensors (thermistors)
T will be assessed under controlled climatic conditions (22°C/40% relative humidity) measuring skin T (°C) at the scapula and the the ribs (lateral) using temperature sensors (thermistors) during 10 minutes sitting and 8 minutes walking as described above.
Measured: 30 minutes
Secondary outcomes (2)
Cognitive performance with neuropsychological tests
Neuropsychological tests will be performed to assess general cognitive performance (Quick Mild Cognitive Impairment screen), episodic memory (associative memory, Face-Name Associative Memory Exam, FNAME-12 test), semantic verbal fluency (category and letter fluency test), and executive functions (Trail Making Tests A/B, Stroop Test). The score of each test will be standardized and added up into a combined score of cognitive performance (z-score).
Measured: 1 hour
Core body temperature (Tc) with telemetric gastrointestinal temperature pill
In a subgroup of 15 participants, Tc (°C) will be recorded with a telemetric gastrointestinal temperature pill over a period of 16 hours.
Measured: 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start23 Sep 2019
- Primary completionMay 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Empa, Swiss Federal Laboratories for Materials Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Geriatrische Klinik St. Gallen, ETH Zurich
- Responsible party
- Principal investigator, Patrick Eggenberger, Empa, Swiss Federal Laboratories for Materials Science and Technology
- Investigators
- Patrick Eggenberger, Dr., Principal investigator, Empa, Swiss Federal Laboratories for Materials Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262674
- Sponsor's protocol ID
- 5213.00187
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Innovative, Non-invasive, Wearable Multi-parameter System for the Early Prediction of Cognitive Decline and Dementia in Older Adults
- ClinicalTrials.gov ID
- NCT04262674
- Acronym / sponsor ID
- 5213.00187
- Conditions
- Mild Cognitive Impairment, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Empa, Swiss Federal Laboratories for Materials Science and TechnologyUniversity, hospital or other
- Collaborators
- Geriatrische Klinik St. Gallen, ETH Zurich
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 10 Feb 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.
This project develops an innovative screening system and prediction model to detect preclinical symptoms of cognitive impairment and predict the potential development of mild cognitive impairments and dementia in older adults. The earliest possible detection of preclinical symptoms is prerequisite to improve the efficacy of subsequent preventative non-pharmacological, life-style and exercise related, personalized treatment interventions.
Detailed description
BACKGROUND: Early detection of preclinical symptoms and prediction of potential development of mild cognitive impairment (MCI) and Alzheimer's disease (AD) could improve non-pharmacologic, life-style and exercise related preventative interventions' efficacy and slow-down disease progression. To achieve this goal, discriminating the earliest preclinical stage of MCI/AD from healthy state would be necessary. However, this is still challenging and current clinical methods are not feasible for preventative screening in larger populations of older adults, as they involve invasive sampling of molecular blood or cerebrospinal fluid biomarkers, as well as expensive brain imaging and extensive neuropsychological testing. Recently, several non-invasive alternative measures, including electroencephalography (EEG), gait analysis, heart rate variability (HRV), and core body temperature (Tc), were shown to be associated with preclinical symptoms of MCI/AD and to predict disease progression.
AIM: The investigators aim to combine these measures in a novel non-invasive multi-parameter prediction model, which better reflects multimodal symptomatology compared to currently used methods and, therefore, allows discriminating healthy persons from MCI state with adequate sensitivity (i.e. >80%).
METHODS: A cohort of 85 older adults, ≥65 years of age, including healthy persons and patients with MCI, will be recruited. Assessments will be performed at baseline, after 2 months (within these two 2 months one group will follow a cognitive-motor training intervention, while the other serves as passive control), and at 12-month follow-up. Assessments include EEG, gait analysis, HRV, and Tc at rest and during walking, and will be compared to reference measures of MCI status, including neuropsychological tests, to develop the prediction model and evaluate its sensitivity.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-motor training | Experimental | Other: Cognitive-motor trainingSimultaneous cognitive-motor training (i.e. exergame) and strength training |
| Control | No intervention | –Passive control group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- participants have to be older than 65 years of age
- cognitively healthy or diagnosed with MCI
- able to walk at least 8 minutes for gait analysis, with or without walking aids
- live independently or in a retirement home (classified 0, 1, or 2 within the Swiss classification system for health-care requirements BESA-levels [German abbreviation for: Bewohner-Einstufungs- und Abrechnungs-System; level 0 meaning the person does not need care or treatment; level 1 to 2 meaning, the person only needs little care or treatment])
- sign informed consent
Key exclusion criteria (8 listed)
- previously diagnosed dementia, e.g. Alzheimer's disease
- recent head injury
- judgment by the participant's primary care physician will be required in the case of acute or instable chronic diseases (e.g. stroke, diabetes) and rapidly progressing or terminal illnesses
- Additional exclusion criteria for the subgroup of 15 participants who would agree to take the telemetric gastrointestinal temperature pill:
- history of operations and/or disease related to the gastrointestinal tract within last 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-motor trainingAlso: Exergame, Step ManiaSimultaneous cognitive-motor training and strength training | Other | Cognitive-motor training |
Primary outcome
Electroencephalography (EEG)
Time frame: 30 minutes
EEG frequency bands (Hz) will be assessed during 10 minutes at rest in a seated position (5 min eyes closed, 5 min eyes open) and will be recorded using a wearable system covering the frontal, parietal, temporal, and occipital cortex and integrating 20 gel-pad electrode channels. The assessment will be continued during the subsequent gait protocol which consists of 8 minutes of walking back and forth at preferred speed on a 20 m track.
Gait speed analysis with inertial sensors
Time frame: 15 minutes
The gait protocol consists of 8 minutes of walking back and forth at preferred speed on a 20 m track. Thereby, walking speed (m/s) will be assessed using inertial sensors attached to the feet.
Gait variability analysis with inertial sensors
Time frame: 15 minutes
The gait protocol consists of 8 minutes of walking back and forth at preferred speed on a 20 m track. Thereby, step length variability (%) and step time variability (%) will be assessed using inertial sensors attached to the feet.
Heart rate variability (HRV) indices SDNN and RMSSD with two-lead electrocardiogram chest belt
Time frame: 10 minutes
The HRV indices SDNN (ms) and RMSSD (ms) will be assessed during 10 minutes in a seated position, using a two-lead electrocardiogram chest belt.
Heart rate variability (HRV) index HF power with two-lead electrocardiogram chest belt
Time frame: 10 minutes
The HRV index HF power (ms^2) will be assessed during 10 minutes in a seated position, using a two-lead electrocardiogram chest belt.
Body temperature (T) with temperature sensors (thermistors)
Time frame: 30 minutes
T will be assessed under controlled climatic conditions (22°C/40% relative humidity) measuring skin T (°C) at the scapula and the the ribs (lateral) using temperature sensors (thermistors) during 10 minutes sitting and 8 minutes walking as described above.
2 secondary outcomes
Cognitive performance with neuropsychological tests
Time frame: 1 hour
Core body temperature (Tc) with telemetric gastrointestinal temperature pill
Time frame: 16 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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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.
Patrick Eggenberger, Dr. principal investigator
Empa, Swiss Federal Laboratories for Materials Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-motor training in people with Mild Cognitive Impairment and Healthy Aging, run by Empa, Swiss Federal Laboratories for Materials Science and Technology at 1 site in Switzerland.
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 5 inclusion and 8 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 4 Feb 2021. 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 Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography (EEG) (time frame: 30 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2021.