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Trial record 1 of 1 for:    NCT05058950
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An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging (Intuition)

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ClinicalTrials.gov Identifier: NCT05058950
Recruitment Status : Terminated (Study was terminated early as part of Biogen's ongoing research and development portfolio management efforts.)
First Posted : September 28, 2021
Last Update Posted : September 21, 2023
Sponsor:
Collaborator:
Apple Inc.
Information provided by (Responsible Party):
Biogen

Study Description
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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.

Condition or disease
Mild Cognitive Impairment Normal Aging

Study Design
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Study Type : Observational
Actual Enrollment : 22720 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging
Actual Study Start Date : September 20, 2021
Actual Primary Completion Date : September 19, 2023
Actual Study Completion Date : September 19, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Sensitivity and Specificity of the Classifier in Predicting Between Individuals Who Do and Do Not Develop 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population include participants with or without mild cognitive impairment.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058950


Locations
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United States, Massachusetts
Virtual App-Based Study
Cambridge, Massachusetts, United States, 02142
Sponsors and Collaborators
Biogen
Apple Inc.
Investigators
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Study Director: Medical Director Biogen
More Information
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Additional Information:

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT05058950    
Other Study ID Numbers: 285PI401
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders