Wearable Sensor for Early Detection and Monitoring of Cognitive Decline

A Multi-Modal Wearable Sensor for Early Detection of Cognitive Decline and Remote Monitoring of Cognitive-Motor Decline Over Time

This observational study will enroll approximately 100 participants evenly split by cognitive status (Cognitively Impaired vs Non-Cognitively Impaired), and involves four clinic visits over one year (at baseline, 3, 6, and 12 months), each followed by 7 days of remote monitoring to assess the long-term feasibility of PAMSys+ (Physical Activity Monitoring System).

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment (MCI); Older Adults; Older Adults With Cognitive Decline

Detailed Description

Understanding someone's language abilities through analyzing their speech using digital tools can be a new, relevant way to find early signs of dementia. Past research shows that changes in a person's speech can accurately reflect the severity of dementia and could even predict cognitive decline before a clinical diagnosis of Alzheimer's disease (AD) is made. Clinical trials have shown that changes in speech can be more noticeable than using traditional screening methods, like the MMSE. Moreover, recent findings suggest that speech changes related to cognitive decline over time aren't influenced by practice or learning effects. Separately, our own research has found that observing people while they're doing two things at once, like walking and talking (known as dual-tasking), can help identify people with mild cognitive impairment, which is an early stage of AD. So, with the support of the studies mentioned above, the goal of this study is to better detect early signs of dementia using everyday behaviors, such as dual-task activities and speech patterns, like how long a person talks while walk at the same time. Investigators intend to create a cheap, simple-to-use pendant device that tracks these behaviors, allowing us to predict small changes in cognitive and motor functions over time.

This is an observational, minimally invasive study. There are four clinic visits (baseline, 3, 6, and 12 months) each followed by 7 days of monitoring. Research staff will supervise tests for all assessments to minimize the risk associated tests such as gait and balance assessments. All in-clinic visits will be conducted at UCLA Health sites.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ashkan Vaziri, PhD; Phone Number: 888-589-6213; Email: ashkan.vaziri@biosensics.com
• Study Contact Backup: Name: Ana Enriquez, BS; Phone Number: 888-589-6213; Email: ana.enriquez@biosensics.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Center for Advanced Surgical & Interventional Technology (CASIT)
      • Principal Investigator: Bijan Najafi, PhD
      • Contact: Bijan Najafi, PhD; Phone Number: (424) 467-7127; Email: bnajafi@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adults 55 years or older with mild cognitive impairement, and non-cognitively impaired.

Description

Inclusion Criteria:

• Adults age 55 years or older
• Ambulatory (able to walk 40 feet with or without walking assistance)
• Willing and able to provide informed consent.
• Individuals in the cognitive impairment group, should either have a diagnosis of cognitive impairment, a MoCA score of 25 or lower, or be confirmation of cognitive impairment by the Principal Investigator or clinical collaborators based on self-reported memory problems and relevant patient history. Individuals in the non-cognitively impaired group must have a MoCA score of 26 or higher.

Exclusion Criteria:

• Children and younger adults: We exclude children and younger adults (younger than 55 years old) as dementia and cognitive-motor impairment is anticipated to be lower among those younger than 55.
• Immobility or major mobility disorder: We will exclude those who were bedbound or unable to stand or ambulate with or without walking assistance (e.g., cane, walker) that prohibit them from performing the 40-foot walking test needed for the Fried Frailty Criteria.
• Pre-existing acute conditions: We will exclude those with acute or unstable conditions (e.g., fractures) that may significantly affect gait and balance, according to the judgement of clinical investigators. In addition, we will exclude those with any significant medical or psychiatric condition that, in the judgment of the investigators, would potentially interfere with the ability to participate in the study.
• Medication: Changes in medication regime unrelated to dementia or those taken temporarily that may affect balance and/or gait (e.g., narcotic, anxiety medication) based on judgement of our clinical investigators.
• Severe vision, aphasia, or healing problems: We will exclude those with major hearing, aphasia, or visual problems, which may limit their ability to complete patient-reported outcomes, complete the cognitive screening assessments, and may impact Dual Task physical activities. Those with corrected vision or hearing problems (e.g., using prescription glasses, hearing aids, etc.) will be included.
• Ongoing treatment: We will exclude those receiving active therapy (e.g., undergoing active chemotherapy or radiotherapy).
• Lack of capacity to consent.
• Other exclusion criteria include the inability to use telemedicine (e.g., no internet at home, severe visual or hearing problem, lack of caregiver support, etc.); inability or unwillingness to participate in scheduled in clinic visits (e.g., living farther than 30 miles from the clinic, unavailability of caregivers). We will also exclude those with significant cognitive impairment (MoCA score<16), severe dementia, severe apathy, severe aphasia or speaking problems, severe depression, those who are on hospice care or palliative care, those with severe pain, and with history of drug or alcohol abuse over the last six months. Finally, we will exclude those who are unable to communicate in English or are unlikely to fully comply with the follow-up protocol (e.g., long travel distance).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cognitively Impaired; Adults with mild cognitive impairment diagnosis or a MoCA scoring of 25 or lower.
Non-Cognitively Impaired; Adults without mild cognitive impairment diagnosis and MoCA scoring of 26 or higher

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	This is a brief global cognitive screening assessment. Scores range from 0 to 30 where 0 represents a worse outcome.	12 months
Dual Task physical activities changes from Baseline to 12 months	Changes in Dual Task physical activities such as gait duration, frequency, cadence, and step variability. Likewise, speech phenotypes such as speech duration, rate, and pause during Dual Task as measured by PAMSys+	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait performance	At each site visits participants will wear LEGSys wearable sensors to collect 15-meter walk at habitual speed, fast speed, and dual task walking (walking while counting backward) The stride velocity unit is m/s.	12 months
Mobility performance	Mobility performance will be collected for duration of one week at each study visit using PAMSys+ to collect: posture duration (e.g., sitting, lying, standing, and walking), daily walking performance (e.g., step count, walking bout count), and postural transition (e.g., total number of sit-to-stand transition, average duration of sit-to-stand postural transition)	12 months
Lawton Instrumental Activities of Daily Living (IADL)	The Lawton Instrumental Activities of Daily Living (IADL) Scale is an 8-item questionnaire that evaluates an individual's ability to live independently. The questionnaire is scored from 0 to 8, where 0 represents a worse outcome.	12 months

Collaborators and Investigators

• Sponsor: BioSensics
• Collaborators: University of California, Los Angeles; National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 30, 2030

Study Registration Dates

• First Submitted: August 19, 2026
• First Submitted That Met QC Criteria: August 19, 2026
• First Posted (Actual): August 21, 2026

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: mild cognitive impairment; digital health; wearable sensors
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: PAMSys Voice Phase II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No