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

Biogen

Status: Terminated

Conditions: Mild Cognitive Impairment; Normal Aging

Study type: Observational

Funder types: Industry

Identifiers

NCT05058950

285PI401

Details and patient eligibility

About

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.

Enrollment: 22,720 patients

Sex: All

Ages: 21 to 86 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

22,720 participants in 8 patient groups

Phenotyped in Research Objectively: Cognitively Normal

Description:

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

Description:

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

Description:

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

Description:

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

Description:

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

Description:

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

Description:

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

Description:

Participants with age 21 to 59 years will be enrolled virtually from the community.