The ADNI4 Digital Study: A novel approach to recruitment, screening, and assessment of participants for AD clinical research

Melanie J Miller^{1

2

3}, Adam Diaz^{1

2

3}, Catherine Conti^{1

2

3}, Bruce Albala^{4

5

6

7}, Derek Flenniken^{1

2

3}, Juliet Fockler^{2

3}, Winnie Kwang^{2

3}, Diana Truran Sacrey^{1

2

3}, Miriam T Ashford^{1

2

3}, Caroline Skirrow⁸, Jack Weston⁸, Emil Fristed⁸, Sarah Tomaszewski Farias⁹, Magda Korecka¹⁰, Yang Wan¹⁰, Paul S Aisen¹¹, Laurel Beckett¹², Danielle Harvey¹², Edward B Lee¹⁰, Ronald C Petersen¹³, Leslie M Shaw¹⁰, Ozioma C Okonkwo¹⁴, Monica Rivera Mindt^{15

16}, Michael W Weiner^{1

2

3}, Rachel L Nosheny^{1

2

3

17}; Alzheimer's Disease Neuroimaging Initiative

Affiliations

¹ Northern California Institute for Research and Education (NCIRE), San Francisco, California, USA.
² VA Advanced Imaging Research Center, Department of Veterans Affairs Medical Center, San Francisco, California, USA.
³ Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, California, USA.
⁴ Department Environmental & Occupational Health, Public Health, University of California Irvine, Irvine, California, USA.
⁵ Department of Neurology, University of California Irvine School of Medicine, Irvine, California, USA.
⁶ Department of Pharmaceutical Sciences, University of California Irvine School of Pharmacy & Pharmaceutical Sciences, Irvine, California, USA.
⁷ Research Service, Veterans Administration Long Beach Healthcare System, Long Beach, California, USA.
⁸ Novoic Ltd., London, UK.
⁹ Department of Neurology, University of California, Davis, Davis, California, USA.
¹⁰ Department of Pathology and Laboratory Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
¹¹ Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego, California, USA.
¹² Department of Public Health Sciences, University of California, Davis, California, USA.
¹³ Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.
¹⁴ Wisconsin Alzheimer's Disease Research Center, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin, USA.
¹⁵ Departments of Psychology, Latin American Latinx Studies Institute, and African and African American Studies, Fordham University, New York, New York, USA.
¹⁶ Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
¹⁷ Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, California, USA.

PMID: 39219153
PMCID: PMC11485063
DOI: 10.1002/alz.14234

The ADNI4 Digital Study: A novel approach to recruitment, screening, and assessment of participants for AD clinical research

Melanie J Miller et al. Alzheimers Dement. 2024 Oct.

. 2024 Oct;20(10):7232-7247.

doi: 10.1002/alz.14234. Epub 2024 Sep 1.

Authors

Affiliations

¹ Northern California Institute for Research and Education (NCIRE), San Francisco, California, USA.
² VA Advanced Imaging Research Center, Department of Veterans Affairs Medical Center, San Francisco, California, USA.
³ Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, California, USA.
⁴ Department Environmental & Occupational Health, Public Health, University of California Irvine, Irvine, California, USA.
⁵ Department of Neurology, University of California Irvine School of Medicine, Irvine, California, USA.
⁶ Department of Pharmaceutical Sciences, University of California Irvine School of Pharmacy & Pharmaceutical Sciences, Irvine, California, USA.
⁷ Research Service, Veterans Administration Long Beach Healthcare System, Long Beach, California, USA.
⁸ Novoic Ltd., London, UK.
⁹ Department of Neurology, University of California, Davis, Davis, California, USA.
¹⁰ Department of Pathology and Laboratory Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
¹¹ Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego, California, USA.
¹² Department of Public Health Sciences, University of California, Davis, California, USA.
¹³ Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.
¹⁴ Wisconsin Alzheimer's Disease Research Center, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin, USA.
¹⁵ Departments of Psychology, Latin American Latinx Studies Institute, and African and African American Studies, Fordham University, New York, New York, USA.
¹⁶ Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
¹⁷ Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, California, USA.

PMID: 39219153
PMCID: PMC11485063
DOI: 10.1002/alz.14234

Abstract

Introduction: We evaluated preliminary feasibility of a digital, culturally-informed approach to recruit and screen participants for the Alzheimer's Disease Neuroimaging Initiative (ADNI4).

Methods: Participants were recruited using digital advertising and completed digital surveys (e.g., demographics, medical exclusion criteria, 12-item Everyday Cognition Scale [ECog-12]), Novoic Storyteller speech-based cognitive test). Completion rates and assessment performance were compared between underrepresented populations (URPs: individuals from ethnoculturally minoritized or low education backgrounds) and non-URPs.

Results: Of 3099 participants who provided contact information, 654 enrolled in the cohort, and 595 completed at least one assessment. Two hundred forty-seven participants were from URPs. Of those enrolled, 465 met ADNI4 inclusion criteria and 237 evidenced possible cognitive impairment from ECog-12 or Storyteller performance. URPs had lower ECog and Storyteller completion rates. Scores varied by ethnocultural group and educational level.

Discussion: Preliminary results demonstrate digital recruitment and screening assessment of an older diverse cohort, including those with possible cognitive impairment, are feasible. Improving engagement and achieving educational diversity are key challenges.

Highlights: A total of 654 participants enrolled in a digital cohort to facilitate ADNI4 recruitment. Culturally-informed digital ads aided enrollment of underrepresented populations. From those enrolled, 42% were from underrepresented ethnocultural and educational groups. Digital screening tools indicate > 50% of participants likely cognitively impaired. Completion rates and assessment performance vary by ethnocultural group and education.

Keywords: Alzheimer's Disease Neuroimaging Initiative (ADNI); Alzheimer's disease (AD); Alzheimer's disease clinical trials; digital assessment; digital recruitment; participant screening; underrepresented populations.

PubMed Disclaimer

Conflict of interest statement

Dr. Miller, Mr. Diaz, and Ms. Conti report no disclosures other than supported by the ADNI4 grant. Dr. Albala, Mr. Flenniken, Ms. Fockler, Ms. Kwang, Ms. Truran Sacery, Dr. Korecka, and Mr. Wan report no disclosures other than supported in part by the ADNI4 grant. Dr. Ashford reports a grant to institution from NIH. Dr. Skirrow is an employee of Novoic Ltd. and is a Novoic option‐holder or shareholder. Dr. Weston is the co‐director of Novoic Ltd. and is a Novoic option‐holder or shareholder. Mr. Fristed is the co‐director of Novoic Ltd. and is a Novoic option‐holder or shareholder. Dr. Tomaszewski Farias reports no disclosures. Dr. Aisen has research grants from Lilly and Eisai, and consults with Merck, Roche, Genentech, Abbvie, Biogen, ImmunoBrain Checkpoint and Arrowhead. Dr. Beckett receives support from NIH (ADNI grant), no conflicts to disclose. Dr. Harvey receives support in the form of grants to University of California, Davis from NIH and serves as a Statistical Advisor for PLOS ONE. Dr. Lee receives support from the NIH and the Delaware Community Foundation. Dr. Petersen has consulted for Roche, Inc., Merck, Inc., Biogen, Inc., Eisai, Inc., Nestle, Inc., and Genentech, Inc. Dr. Shaw receives support from Roche (IIS and in‐kind reagents and instrumentation support for CSF AD biomarkers). He has also received honoraria from Roche, Biogen, and Fujirebio for participation in teaching programs and served on Advisory Boards for Roche and Biogen. Dr. Okonkwo is supported by NIH grants to the University of Wisconsin‐Madison. Dr. Rivera Mindt receives support in the form of grants to Fordham University or the Icahn School of Medicine at Mount Sinai from NIH/NIA, The Alzheimer's Association, and Genentech Inc. Charitable Foundation. Dr. Weiner serves on editorial boards for Alzheimer's Dement, MRI and TMRI. He has served on advisory boards for Acumen Pharmaceutical, ADNI, Alzheon, Inc., Biogen, Brain Health Registry, Cerecin, Dolby Family Ventures, Eli Lilly, Merck Sharp & Dohme Corp., National Institute on Aging (NIA), Nestle/Nestec, PCORI/PPRN, Roche, University of Southern California (USC), NervGen. He has provided consulting to Baird Equity Capital, BioClinica, Cerecin, Inc., Cytox, Dolby Family Ventures, Duke University, Eisai, FUJIFILM‐Toyama Chemical (Japan), Garfield Weston, Genentech, Guidepoint Global, Indiana University, Japanese Organization for Medical Device Development, Inc. (JOMDD), Medscape, Nestle/Nestec, NIH, Peerview Internal Medicine, Roche, T3D Therapeutics, University of Southern California (USC), and Vida Ventures. He has acted as a speaker/lecturer to The Buck Institute for Research on Aging, China Association for Alzheimer's Disease (CAAD), Japan Society for Dementia Research, and Korean Dementia Society. He holds stock options with Alzheon, Inc., Alzeca, and Anven. The following entities have provided funding for academic travel: University of Southern California (USC), NervGen, ASFNR, and CTAD Congress. Dr. Rachel L. Nosheny reports grants to institution from NIH, California Department of Public Health, and Genentech, Inc. Author disclosures are available in the supporting information.

Figures

**FIGURE 1**
Consort diagram of participants included in the ADNI4 Remote Digital Cohort. ADNI, Alzheimer's Disease Neuroimaging Initiative; ECog‐12, Everyday Cognition 12‐item questionnaire.

**FIGURE 2**
Association between demographic and cognitive characteristics and completion of Novoic Storyteller assessment. Results of logistic regression with completion of Novoic Storyteller as the dependent variable. Odds ratios and 95% confidence intervals for each independent variable are displayed.

**FIGURE 3**
Score distributions and correlation between Novoic Storyteller and Self‐Report ECog‐12. Score distributions for Self‐Report ECog‐12 and Novoic Storyteller, with a scatter plot of assessment scores. Spearmans *rho* = −0.27. ECog‐12, Everyday Cognition 12‐item questionnaire.

**FIGURE 4**
Evidence for cognitive impairment indicated by Novoic Storyteller and Self‐Report ECog‐12 scores. Scatter plot of Novoic Storyteller and Self‐Report ECog‐12 scores, with cut offs for likely impairment (49.4 for Novoic Storyteller G‐match, 1.36 for total Self‐Report ECog‐12 score) indicated by black lines. Points are color coded according to whether the participant indicated additional evidence for cognitive impairment (self‐report of MCI, dementia, or AD and/or taking a medication for cognitive impairment). AD, Alzheimer's disease; ECog‐12, Everyday Cognition 12‐item questionnaire; MCI, mild cognitive impairment.

See this image and copyright information in PMC

References

1. Dementia As . 2023 Alzheimer's disease facts and figures. Alzheimer's Dement. 2023;19:1598‐1695. - PubMed
1. Cummings J, Zhou Y, Lee G, Zhong K, Fonseca J, Cheng F. Alzheimer's disease drug development pipeline: 2023. Alzheimer's Dement: Transl Res Clin Interventions. 2023;9:e12385. - PMC - PubMed
1. Weiner MW, Veitch DP, Miller MJ, et al. Increasing participant diversity in AD research: plans for digital screening, blood testing, and a community‐engaged approach in the Alzheimer's Disease Neuroimaging Initiative 4. Alzheimer's Dement. 2023;19:307‐317. - PMC - PubMed
1. Chen C, Zissimopoulos JM. Racial and ethnic differences in trends in dementia prevalence and risk factors in the United States. Alzheimer's Dement: Transl Res Clin Interventions. 2018;4:510‐520. - PMC - PubMed
1. Oh SS, Galanter J, Thakur N, et al. Diversity in clinical and biomedical research: a promise yet to be fulfilled. PLoS Med. 2015;12:e1001918. - PMC - PubMed

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Grants and funding

LinkOut - more resources

Full Text Sources
Medical
- MedlinePlus Health Information
Miscellaneous
- NCI CPTAC Assay Portal

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

The ADNI4 Digital Study: A novel approach to recruitment, screening, and assessment of participants for AD clinical research

Affiliations

The ADNI4 Digital Study: A novel approach to recruitment, screening, and assessment of participants for AD clinical research

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous