Clinical trial NCT04262674: Non-invasive, Wearable Multi-parameter System for the Early Prediction of Cognitive Decline and Dementia in Older Adults
Official title: Development of an Innovative, Non-invasive, Wearable Multi-parameter System for the Early Prediction of Cognitive Decline and Dementia in Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Healthy Aging
Lead sponsor: Empa, Swiss Federal Laboratories for Materials Science and Technology
Sponsor class: OTHER
Collaborators: name: Geriatrische Klinik St. Gallen
name: ETH Zurich
First posted: 2020-02-10
Enrollment: 82
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Electroencephalography (EEG)
timeFrame: 30 minutes
measure: Gait speed analysis with inertial sensors
timeFrame: 15 minutes
measure: Gait variability analysis with inertial sensors
timeFrame: 15 minutes
measure: Heart rate variability (HRV) indices SDNN and RMSSD with two-lead electrocardiogram chest belt
timeFrame: 10 minutes
measure: Heart rate variability (HRV) index HF power with two-lead electrocardiogram chest belt
timeFrame: 10 minutes
measure: Body temperature (T) with temperature sensors (thermistors)
timeFrame: 30 minutes
Secondary outcomes:
measure: Cognitive performance with neuropsychological tests
timeFrame: 1 hour
measure: Core body temperature (Tc) with telemetric gastrointestinal temperature pill
timeFrame: 16 hours
Other outcomes:
Locations:
city: St.Gallen
country: Switzerland
facility: Empa
state: SG
Study officials:
affiliation: Empa, Swiss Federal Laboratories for Materials Science and Technology
name: Patrick Eggenberger, Dr.
role: PRINCIPAL_INVESTIGATOR
References: