Health TrialsbyHealthPanel

Wearable Sensor for Early Detection and Monitoring of Cognitive Decline

ConditionsMild Cognitive Impairment (MCI)Older Adults With Cognitive DeclineOlder Adults
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorBioSensics

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Cognitively Impaired
Group B: Non-Cognitively Impaired

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioSensics

Lead sponsor

University of California, Los Angeles

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: