An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging

Terminated

• Conditions: Mild Cognitive Impairment; Normal Aging

• Registration Number: NCT05058950
• Lead Sponsor: Biogen

Brief Summary

The primary objectives are to develop and validate a classifier using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage to distinguish individuals with normal cognition from those with mild cognitive impairment (MCI) and to develop and validate a cognitive wellness score that tracks fluctuations in cognitive performance over time using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-17
• Study Start: 2021-09-20
• Study First Posted: 2021-09-28
• Status Verified: 2023-09
• Primary Completion: 2023-09-19
• Study Completion: 2023-09-19
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22720

Inclusion Criteria

• Fluent in spoken and written English
• Minimum 8 years of education or 8th grade equivalent.
• Willing to authorize the use of confidential health information in accordance with applicable privacy regulations.
• Willing to wear an Apple Watch for daily use for the duration of the study.
• Willing to use their personal iPhone for routine daily use for the duration of the study.
• Technical requirements:

iPhone models: iPhone 8 or newer iOS versions: current publicly available iOS version

• Access to one of the following personal computing devices. Microsoft Windows based personal computers (laptops and desktops) Mac personal computers (laptops and desktops) Apple iPad tablets
• Access to WiFi or hardwired internet access in participant's place of residence.
• Active email address for enrollment account creation and for use in relaying study information.
• Active mobile telephone number for use in relaying study information when appropriate.
• Primary address within the United States (50 states and Washington, DC; not a post office (PO) box).

Key

Exclusion Criteria

• Inability to comply with study requirements.
• Any self-reported medical history of dementia (such as Alzheimer's disease, frontotemporal dementia, dementia with Lewy body, vascular dementia, rapidly progressive dementia, or Parkinson's disease dementia).
• Self-reported dependence on others to perform core activities of daily living, including feeding, dressing, bathing, toileting, or grooming.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of the Classifier in Distinguishing Between Individuals With and Without MCI	Up to Month 23	A classifier is a mathematical function that uses collected data to calculate the probability that an individual belongs in a given category. The reference standard for the classifier is clinical diagnosis of MCI in normal clinical care or in a research cohort.
Correlation Between the Cognitive Wellness Score and the Neuropsychological Testing Battery Score	Up to Month 23	To develop and validate a cognitive wellness score that tracks fluctuations in cognitive performance over time using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of the Classifier in Predicting Between Individuals Who Do and Do Not Develop MCI	Up to Month 23	A classifier is a mathematical function that uses collected data to calculate the probability that an individual belongs in a given category. The reference standard for the classifier is clinical diagnosis of MCI in normal clinical care or in a research cohort.

Trial Locations

Locations (1)

Virtual App-Based Study; 🇺🇸 Cambridge, Massachusetts, United States