Non-invasive, Wearable Multi-parameter System for the Early Prediction of Cognitive Decline and Dementia in Older Adults

NCT ID: NCT04262674

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2021-07-31

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.

Conditions

Mild Cognitive Impairment; Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Cognitive-motor training

Simultaneous cognitive-motor training (i.e. exergame) and strength training

Group Type: EXPERIMENTAL

Cognitive-motor training

Intervention Type: OTHER

Simultaneous cognitive-motor training and strength training

Control

Passive control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive-motor training

Simultaneous cognitive-motor training and strength training

Intervention Type: OTHER

Other Intervention Names

Exergame; Step Mania

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

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geriatrische Klinik St. Gallen

OTHER

Sponsor Role: collaborator

ETH Zurich

OTHER

Sponsor Role: collaborator

Empa, Swiss Federal Laboratories for Materials Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Patrick Eggenberger

Principal Investigator, Postdoc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Eggenberger, Dr.

Role: PRINCIPAL_INVESTIGATOR

Empa, Swiss Federal Laboratories for Materials Science and Technology

Locations

Empa

Sankt Gallen, Canton of St. Gallen, Switzerland

Countries

Switzerland

Other Identifiers

5213.00187

Identifier Type: -

Identifier Source: org_study_id