Clinical trial NCT05058950: An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging
Official title: An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mild Cognitive Impairment
Normal Aging
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Apple Inc.
First posted: 2021-09-28
Enrollment: 22720
Sex: ALL
Minimum age (years): 21
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population include participants with or without mild cognitive impairment.

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.


Eligibility criteria: Key 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.

Primary outcomes:
measure: Sensitivity and Specificity of the Classifier in Distinguishing Between Individuals With and Without MCI
timeFrame: Up to Month 23
measure: Correlation Between the Cognitive Wellness Score and the Neuropsychological Testing Battery Score
timeFrame: Up to Month 23
Secondary outcomes:
measure: Sensitivity and Specificity of the Classifier in Predicting Between Individuals Who Do and Do Not Develop MCI
timeFrame: Up to Month 23
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Virtual App-Based Study
state: Massachusetts
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: