This blog series shares what’s happening day-to-day in our Innovation Lab. VeraSci created the Innovation Lab to pair scientific knowledge with cutting-edge technology to improve the tools and measurements available for clinical trials. We originally presented these results at the Clinical Trials on Alzheimer’s Disease (CTAD) Digital Event. Click here to download the poster.

Measurements from validated wearable technologies have the potential to revolutionize clinical trials by facilitating site-less clinical trial designs. However, for this to become a reality, endpoints collected using wearables must undergo the same clinical and technological validation processes required by currently accepted tools. VeraSci’s Innovation Lab has been conducting an NIH-funded study examining the relationship between real-time measurements of gait and actigraphy collected by industry-grade wearables and established cognitive and functional endpoints that are sensitive to decline early in the Alzheimer’s disease continuum.

The preliminary data presented at CTAD and summarized below suggest correlations between remotely captured actigraphy and gait measures and established assessments of cognition and function, suggesting wearables can provide meaningful information regarding cognitive health and may ultimately contribute to continuous assessment of cognition and function in clinical trials.

About the Study

The study has enrolled 38 older adults (55+), including 26 healthy controls and 12 age-matched individuals with subjective cognitive decline. Participants attended two in-person study visits separated by one week of passive data collection using two wearable devices. At the first visit, participants completed well-established motor, cognitive, and functional assessments, including the Computerized Finger Tapping Test (CTAP), Timed 25-Foot Walk Test (T25-FW), Timed “Up and Go” (TUG), VeraSci’s Brief Assessment of Cognition (BAC), and the Virtual Reality Functional Capacity Assessment Tool (VRFCAT). At the second visit, participants repeated a portion of the in-office walking assessments.

The two wearable devices used by participants were the Empatica E2 wristband and the Moticon Science Insoles. The Empatica E2 wristband provided continuous measurement of motor activity (i.e., actigraphy), galvanic skin response, skin temperature, and sleep. The Moticon Science Insoles passively collect gait and movement data. The insoles characterize the subject’s gait across a gait cycle and within a specific phase of a gait cycle (see figure below).

phases of the gait cycle

Results

Participants with subjective cognitive decline performed significantly worse than the healthy controls on the BAC and the VRFCAT, indicating objective impairments in the subject cognitive decline sample.

Cognitive scores by group
VRFCAT scores by group

Participants with subjective cognitive decline performed worse on a portion of motor functioning assessments administered at the first visit. They were significantly slower than the healthy control group at completing the TUG. On the CTAP, individuals with subjective cognitive decline produced significantly fewer button presses with their non-dominant hand and using both hands, but the difference for the dominant hand was not significant.

For the Empatica E2 device, compliance rates during the at-home portion of the study were significantly lower for individuals with subjective cognitive decline than the healthy control group. Correlational analyses across the combined sample indicated several associations between E2 endpoints and cognition (see table below). There was a strong positive correlation between cognition/function and daily activity/movement. The average waking activity level was positively correlated with BAC verbal fluency, verbal list learning, symbol coding, and VRFCAT completion time.

The Moticon Science Insoles revealed that participants with subjective cognitive decline exhibit different gait parameters than healthy control subjects. Correlational analyses across the combined sample revealed associations of gait measures with functional capacity and cognitive endpoints (see table below). These results suggest that lower gait efficiency is associated with reduced functional capacity.

correlation between empatica and cognitive measures

Conclusions

These preliminary findings highlight the challenges of integrating wearable technologies into clinical trials for participants with even mild cognitive defects.

Despite compliance issues, preliminary data indicate moderate correlations between remotely captured actigraphy and gait measures and established assessments of cognition and function, suggesting wearables can provide meaningful information regarding cognitive health and may ultimately contribute to continuous assessment of cognition and function in clinical trials.

Learn more about VeraSci’s experience in Alzheimer’s clinical trials.