Use of Wearables for Identifying Factors Associated With Mild Cognitive Impairment and Early-Stage Alzheimer's Disease

Summary

Cognitive decline affects millions of older adults worldwide and has a profound impact on individuals, families, and healthcare systems. Mild Cognitive Impairment (MCI) is often an early stage of Alzheimer's disease (AD), a condition for which there is currently no cure. Identifying individuals at risk at the earliest possible stage remains a major challenge. Traditional diagnostic approaches, such as laboratory biomarkers, neuroimaging, and neuropsychological testing, are usually performed at a single point in time and may fail to detect subtle or early changes in brain function and daily behavior.

Recent advances in wearable technology, such as smartwatches and smart rings, allow continuous and noninvasive monitoring of physiological and behavioral patterns in daily life. These devices can capture data related to physical activity, sleep, heart rate, and other parameters that may change before clear cognitive symptoms become evident. When combined with clinical, laboratory, neuropsychological, neuroimaging, and electroencephalographic (EEG) information, these data may help identify early signs of cognitive decline.

The objective of this study is to develop and validate models capable of detecting early indicators of MCI and early-stage Alzheimer's disease by integrating multiple sources of data, including clinical assessments, blood tests, neuropsychological evaluations, brain imaging, EEG recordings, and continuous data obtained from wearable devices.

This is an observational, analytical, single-center, prospective cohort study that will include 150 participants of both sexes, aged 65 years or older. Participants will be recruited from the Dementia Outpatient Clinic of Getúlio Vargas University Hospital (HUGV), through referrals from external neurologists, or via study dissemination on social media. To achieve the target sample size, up to 250 individuals may be approached using a non-probabilistic, convenience-based recruitment strategy. After providing informed consent, participants will undergo a comprehensive medical evaluation, standardized and validated neuropsychological testing, laboratory and imaging examinations, and EEG recording. Participants will also receive training to use wearable devices for continuous monitoring in their daily routines. A control group of older adults without cognitive impairment will be included for comparison.

All collected data will be securely stored in a centralized database and used to develop and validate analytical models aimed at identifying patterns associated with cognitive decline. The results of this study may support earlier identification of individuals at risk for MCI and Alzheimer's disease, help guide timely interventions, and potentially delay disease progression and early institutionalization, contributing to improved quality of life for older adults and their families.

Conditions

• Mild Cognitive Impairment
• Alzheimer's Disease
• Alzheimer's Disease Dementia

Sponsors & Collaborators

• Universidade Federal do Amazonas

  collaborator OTHER

• Samsung Eletrônica da Amazônia Ltda

  collaborator UNKNOWN

• Getúlio Vargas University Hospital

  lead OTHER_GOV

Principal Investigators

• Robson Luís Oliveira de Amorim · Getúlio Vargas University Hospital

• Eliana Brasil Alves · Getúlio Vargas University Hospital

• Marly Guimarães Fernandes Costa · Federal University of Amazonas

• Cícero Ferreira Fernandes Costa Filho · Federal University of Amazonas

• Caio Eduardo Rodrigues Falcão · Getúlio Vargas University Hospital

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2027-07-31

Completion

2027-12-31

Countries

• Brazil

Study Locations