Mild Cognitive ImpairmentIntuitionNCT05058950

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

An observational study of Mild Cognitive Impairment and Normal Aging, run by Biogen at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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… Read more about this study

Who is it for?: Ages 21 to 86 yearsHealthy volunteers can take part
Conditions the study is for: Mild Cognitive Impairment, Normal Aging
How many people: 22,720 participants
Where: 1 siteUnited States
Study dates: 20 Sep 2021to 19 Sep 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 86 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: The study population include participants with or without mild cognitive impairment.

Who may be able to join

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:

Show all 12Show fewer

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).

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Virtual App-Based Study
Cambridge, Massachusetts, 02142

Other trials in United States

About this study

Conditions: Mild Cognitive Impairment, Normal Aging
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05058950
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to Month 23
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.
Measured: Up to Month 23

Secondary outcomes (1)

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.
Measured: Up to Month 23

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 202119 Sep 2023

First posted28 Sep 2021
Study start20 Sep 2021
Primary completion19 Sep 2023
Study completion19 Sep 2023

Why it stopped: Study was terminated early as part of Biogen's ongoing research and development portfolio management efforts.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by BiogenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 22,720 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05058950
Sponsor's protocol ID: 285PI401
Acronym: Intuition
Status last verified: Sep 2023
First submitted: 17 Sep 2021
Last updated: 21 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com

Publications

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.
PubMed 40038507

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging
ClinicalTrials.gov ID: NCT05058950
Acronym / sponsor ID: Intuition / 285PI401
Conditions: Mild Cognitive Impairment, Normal Aging
Study type: Observational
Recruitment status: TerminatedReason stopped: Study was terminated early as part of Biogen's ongoing research and development portfolio management efforts.
Enrolment: 22,720 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Collaborators: Apple Inc.
Study start: 20 Sep 2021 (actual)
Primary completion: 19 Sep 2023 (actual)
Study completion: 19 Sep 2023 (actual)
First posted: 28 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 8

Arm	Type	Receives
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.

Who may qualify

Ages: 21 to 86 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: The study population include participants with or without mild cognitive impairment.

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.

1 secondary outcome

Sensitivity and Specificity of the Classifier in Predicting Between Individuals Who Do and Do Not Develop MCI
Time frame: Up to Month 23

Results and safety

The study was stopped early (reason given: Study was terminated early as part of Biogen's ongoing research and development portfolio management efforts.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Derived from this study: PubMed 40038507Butler 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.
For additional information about the study: https://www.intuitionstudy.com/Link provided by the sponsor.
To download the app: https://apps.apple.com/us/app/intuition-brain-health-study/id1574756244?form=MY01SV\&OCID=MY01SVLink provided by the sponsor.
Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com

Related trials for Mild Cognitive Impairment

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Biogen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Cognitive Impairment and Normal Aging, run by Biogen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and Specificity of the Classifier in Distinguishing Between Individuals With and Without MCI (time frame: Up to Month 23). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05058950, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.