An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Biogen
- Enrollment
- 22720
- Locations
- 1
- Primary Endpoint
- Sensitivity and Specificity of the Classifier in Distinguishing Between Individuals With and Without MCI
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Sensitivity and Specificity of the Classifier in Distinguishing Between Individuals With and Without MCI
Time Frame: 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
Time Frame: 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 Outcomes
- Sensitivity and Specificity of the Classifier in Predicting Between Individuals Who Do and Do Not Develop MCI(Up to Month 23)