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Study was terminated early as part of Biogen's ongoing research and development portfolio management efforts.
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| Name | Class |
|---|---|
| Apple Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to Month 23 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Month 23 |
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Key Inclusion Criteria:
iPhone models: iPhone 8 or newer iOS versions: current publicly available iOS version
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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The study population include participants with or without mild cognitive impairment.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virtual App-Based Study | Cambridge | Massachusetts | 02142 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40038507 | Derived | 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. |
| Label | URL |
|---|---|
| For additional information about the study: https://www.intuitionstudy.com/ | View source |
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In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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. |