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

Mild Cognitive Impairment Clinical Trial

— Intuition  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05058950
• Other study ID #: 285PI401
• Status: Terminated
• Start date: September 20, 2021
• Est. completion date: September 19, 2023

Study information

• Verified date: September 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22720
• Est. completion date: September 19, 2023
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 86 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Normal Aging

Locations

Country	Name	City	State
United States	Virtual App-Based Study	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Apple Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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

External 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