Mild Cognitive Impairment (MCI)NCT07780162
Wearable Sensor for Early Detection and Monitoring of Cognitive Decline
An observational study of Mild Cognitive Impairment (MCI) and Older Adults With Cognitive Decline, run by BioSensics at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Older Adults With Cognitive Decline, Older Adults
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2026to 30 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Adult, Older adult
Study population: Adults 55 years or older with mild cognitive impairement, and non-cognitively impaired.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCLA Center for Advanced Surgical & Interventional Technology (CASIT)
Los Angeles, California, 90095
Bijan Najafi, PhD, (424) 467-7127, bnajafi@mednet.ucla.edu
Bijan Najafi, PhD
About this study
Official title: 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).
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.
- Keywords
- digital health, wearable sensors, mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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+
Measured: 12 months
Montreal Cognitive Assessment (MoCA)
This is a brief global cognitive screening assessment. Scores range from 0 to 30 where 0 represents a worse outcome.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start15 Dec 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSensics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780162
- Sponsor's protocol ID
- PAMSys Voice Phase II
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Modal Wearable Sensor for Early Detection of Cognitive Decline and Remote Monitoring of Cognitive-Motor Decline Over Time
- ClinicalTrials.gov ID
- NCT07780162
- Acronym / sponsor ID
- PAMSys Voice Phase II
- Keywords
- digital health, wearable sensors, mild cognitive impairment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BioSensicsIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, National Institutes of Health (NIH)
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults 55 years or older with mild cognitive impairement, and non-cognitively impaired.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dual Task physical activities changes from Baseline to 12 months
Time frame: 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+
Montreal Cognitive Assessment (MoCA)
Time frame: 12 months
This is a brief global cognitive screening assessment. Scores range from 0 to 30 where 0 represents a worse outcome.
3 secondary outcomes
Gait performance
Time frame: 12 months
Mobility performance
Time frame: 12 months
Lawton Instrumental Activities of Daily Living (IADL)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment (MCI) and Older Adults With Cognitive Decline, run by BioSensics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashkan Vaziri, PhD (888-589-6213, ashkan.vaziri@biosensics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual Task physical activities changes from Baseline to 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.