ClinicalTrials.gg
Not yet recruitingNCT07780162Updated Sep 2, 2026

Wearable Sensor for Early Detection and Monitoring of Cognitive Decline

An observational study in Mild Cognitive Impairment (MCI), Older Adults With Cognitive Decline and Older Adults, sponsored by BioSensics. Not yet recruiting at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by BioSensics · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
55 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,418 studies in Cognitive Dysfunction with a site in United States — 328 open to participants now, 432 under way, 13 of them phase 3. Cognitive Dysfunction · United States.

Planned enrollment
157th of 270
100 · median 150
Started
2026
with 93 others
Observational
270 of 1,418
67 open now
Primary completion
2029-12
later than 398 of 431 live
Registered
1,403rd of 1,418
by date

Among the 1,418 studies in Cognitive Dysfunction with a site in United States, this one is the 157th largest by planned enrollment of the 270 observational ones that give a count, is one of 94 that started in 2026, is one of 270 observational ones, reaches primary completion later than 398 of the 431 other live ones, and was the 1,403rd registered.

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 100 is below the median of 150 across 997 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Open to participants now

328 of the 1,418 studies in Cognitive Dysfunction with a site in United States are open now.

All 328 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.

This study: 55 Years and older · all sexes.

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02

Study summary

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).

Read the 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.

03

Conditions studied

  • Mild Cognitive Impairment (MCI)
  • Older Adults With Cognitive Decline
  • Older Adults

Keywords

  • digital health
  • wearable sensors
  • mild cognitive impairment
04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults age 55 years or older
  • Ambulatory (able to walk 40 feet with or without walking assistance)
  • Willing and able to provide .
  • Individuals in the cognitive impairment group, should either have a diagnosis of cognitive impairment, a 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

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 ( 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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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+

    Time frame: 12 months

  2. Montreal Cognitive Assessment (MoCA)

    This is a brief global cognitive screening assessment. Scores range from 0 to 30 where 0 represents a worse outcome.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. 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)

    Time frame: 12 months

  3. 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.

    Time frame: 12 months

07

Study locations

1 site
  • UCLA Center for Advanced Surgical & Interventional Technology (CASIT)
    Los Angeles, California 90095, United States
    • Bijan Najafi, PhD · Contactbnajafi@mednet.ucla.edu · (424) 467-7127
    • Bijan Najafi, PhD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2029, 36 months later.

Of 543 observational studies under Cognitive Dysfunction, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 118. This study's planned 36 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Aug 21, 2026
StartEst.
Dec 15, 2026
Primary completionEst.
Dec 31, 2029
CompletionEst.
Mar 30, 2030
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07780162
Lead sponsor
BioSensics
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Dec 15, 2026 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Mar 30, 2030 (estimated)
Last update
Sep 2, 2026

Study contacts

Ashkan Vaziri, PhD
Contact
ashkan.vaziri@biosensics.com
888-589-6213
Ana Enriquez, BS
Contact
ana.enriquez@biosensics.com
888-589-6213

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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