An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging
NCT ID: NCT05058950
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
22720 participants
OBSERVATIONAL
2021-09-20
2023-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Aging Across Adulthood: Cognitively Normal
Participants with age 21 to 59 years will be enrolled virtually from the community.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
21 Years
86 Years
ALL
Yes
Sponsors
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Apple Inc.
INDUSTRY
Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Virtual App-Based Study
Cambridge, Massachusetts, United States
Countries
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References
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Butler PM, Yang J, Brown R, Hobbs M, Becker A, Penalver-Andres J, Syz P, Muller S, Cosne G, Juraver A, Song HH, Saha-Chaudhuri P, Roggen D, Scotland A, Silveira N, Demircioglu G, Gabelle A, Hughes R, Erkkinen MG, Langbaum JB, Lingler JH, Price P, Quiroz YT, Sha SJ, Sliwinski M, Porsteinsson AP, Au R, Bianchi MT, Lenyoun H, Pham H, Patel M, Belachew S. Smartwatch- and smartphone-based remote assessment of brain health and detection of mild cognitive impairment. Nat Med. 2025 Mar;31(3):829-839. doi: 10.1038/s41591-024-03475-9. Epub 2025 Mar 4.
Related Links
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For additional information about the study: https://www.intuitionstudy.com/
Other Identifiers
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285PI401
Identifier Type: -
Identifier Source: org_study_id
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