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
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.
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.
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 →328 of the 1,418 studies in Cognitive Dysfunction with a site in United States are open now.
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 →
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.
The full table on the hub →1,418 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 125 · Phase 2 233 · Phase 3 54 · Phase 4 58
First in 1993; this study’s year is marked. 94 started in 2026.
Median enrollment 58 across the 1,143 interventional studies, 150 across the 270 observational. Of the 885 that completed or were terminated, 377 (43%) have results posted.
209 of 1,418 have an industry lead sponsor. The 10 most frequent:
BioSensics is the lead sponsor of 12 studies on the registry; 8 are open to participants now.
BioSensics has 1 study filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
176 of the studies in Cognitive Dysfunction with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03860857Phase 3University of California, IrvineBiomarker Exploration in Aging, Cognition and Neurodegeneration | 2026-12-22 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT06191965Phase 3Mclean HospitalMitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction | 2027-01-31 |
| NCT06950190Phase 3Ellis MedicineEvaluating Cognitive Changes on Patients in Chemotherapy (ECCPC) | 2027-02-20 |
| NCT03560960Boston UniversityMulti-Center Development of a Novel Diagnostic Test for Alzheimer's Disease | 2026-11 |
Among the 1,418 studies in Cognitive Dysfunction with a site in United States, from their registry updates:
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).
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.
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.
Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with mild cognitive impairment diagnosis or a MoCA scoring of 25 or lower.
Adults without mild cognitive impairment diagnosis and MoCA scoring of 26 or higher
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
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
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
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
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
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.
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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