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

September 19, 2023 updated by: Biogen
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22720

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to Month 23
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.
Up to Month 23

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to Month 23

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Apple Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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