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

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.

Study Overview

• Status: Terminated
• Conditions: Mild Cognitive Impairment; Normal Aging

• Study Type: Observational
• Enrollment (Actual): 22720

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02142
      • Virtual App-Based Study

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population include participants with or without mild cognitive impairment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
Phenotyped in Research Objectively: Cognitively Normal; Participants with age ≥50 years and with a label of "cognitively normal" or its equivalent based on a clinical or research evaluation in the past 24 months will be enrolled virtually.
Phenotyped in Research Objectively: MCI; Participants with age ≥50 years, with a label of "MCI" or its equivalent based on a clinical or research evaluation in the past 24 months will be enrolled virtually.
Phenotyped in Research Objectively: Exploratory Biomarker; Participants with age ≥50 years, with documented positive result for an Alzheimer's disease biomarker, and with a label of "subjective cognitive complaints" or "cognitively normal" or its equivalent based on a clinical or research evaluation in the past 24 months will be enrolled virtually.
Aging Across Adulthood: MCI; Participants with age ≥50 years, with a diagnosis of MCI, mild neurocognitive disorder (MND), or cognitively impaired, not demented (CIND) will be enrolled virtually from the community.
Aging Across Adulthood: Subjective Cognitive Complaint; Participants with age ≥50 years and positive screen result from Cognitive Function Instrument (CFI) will be enrolled virtually from the community.
Aging Across Adulthood: Cognitively Normal With Risk Factor For Dementia; Participants with age ≥60 years and self-reported history of a minimum of 2-4 risk factors for cognitive decline will be enrolled virtually from the community.
Aging Across Adulthood: Cognitively Normal Without Risk Factors For Dementia; Participants with age ≥60 years having missing descriptor of minimal risk factors for cognitive decline will be enrolled virtually from the community.
Aging Across Adulthood: Cognitively Normal; Participants with age 21 to 59 years will be enrolled virtually from the community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of the Classifier in Distinguishing Between Individuals With and Without MCI	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.	Up to Month 23
Correlation Between the Cognitive Wellness Score and the Neuropsychological Testing Battery Score	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.	Up to Month 23

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of the Classifier in Predicting Between Individuals Who Do and Do Not Develop MCI	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.	Up to Month 23

Collaborators and Investigators

• Sponsor: Biogen
• Collaborators: Apple Inc.
• Investigators: Study Director: Medical Director, Biogen

Publications and helpful links

Helpful Links

• For additional information about the study: https://www.intuitionstudy.com/
• To download the app: https://apps.apple.com/us/app/intuition-brain-health-study/id1574756244?form=MY01SV&OCID=MY01SV

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): September 19, 2023
• Study Completion (Actual): September 19, 2023

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 285PI401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No