A Biomarker Database to Investigate Blood-Based and Digital Biomarkers in Participants Screened for Alzheimer's Disease (Bio-Hermes)

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ClinicalTrials.gov Identifier: NCT04733989

Recruitment Status : Completed

First Posted : February 2, 2021

Last Update Posted : February 9, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

GAP Innovations, PBC

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Completed
Actual Primary Completion Date :	November 11, 2022
Actual Study Completion Date :	November 11, 2022

Publications:

Baek MJ, Kim K, Park YH, Kim S. The Validity and Reliability of the Mini-Mental State Examination-2 for Detecting Mild Cognitive Impairment and Alzheimer's Disease in a Korean Population. PLoS One. 2016 Sep 26;11(9):e0163792. doi: 10.1371/journal.pone.0163792. eCollection 2016.

Berry CC. A tutorial on confidence intervals for proportions in diagnostic radiology. AJR Am J Roentgenol. 1990 Mar;154(3):477-80. doi: 10.2214/ajr.154.3.2106207. No abstract available.

Cahn-Hidalgo D, Estes PW, Benabou R. Validity, reliability, and psychometric properties of a computerized, cognitive assessment test (Cognivue(R)). World J Psychiatry. 2020 Jan 19;10(1):1-11. doi: 10.5498/wjp.v10.i1.1. eCollection 2020 Jan 19.

Chetelat G, La Joie R, Villain N, Perrotin A, de La Sayette V, Eustache F, Vandenberghe R. Amyloid imaging in cognitively normal individuals, at-risk populations and preclinical Alzheimer's disease. Neuroimage Clin. 2013 Mar 5;2:356-65. doi: 10.1016/j.nicl.2013.02.006. eCollection 2013.

Giri M, Zhang M, Lu Y. Genes associated with Alzheimer's disease: an overview and current status. Clin Interv Aging. 2016 May 17;11:665-81. doi: 10.2147/CIA.S105769. eCollection 2016.

Howell JC, Watts KD, Parker MW, Wu J, Kollhoff A, Wingo TS, Dorbin CD, Qiu D, Hu WT. Race modifies the relationship between cognition and Alzheimer's disease cerebrospinal fluid biomarkers. Alzheimers Res Ther. 2017 Nov 2;9(1):88. doi: 10.1186/s13195-017-0315-1.

Ingelfinger, JA, Mosteller, R, Thibodeau, LA, Ware, JA. Biostatistics in Clinical Medicine. 3rd ed. New York, N.Y.: McGraw-Hill, New York; 1994.

Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.

Kantarci K. Molecular imaging of Alzheimer disease pathology. AJNR Am J Neuroradiol. 2014 Jun;35(6 Suppl):S12-7. doi: 10.3174/ajnr.A3847. Epub 2014 Feb 6.

Malzbender K, Lavin-Mena L, Hughes L, Bose N, Goldman D, Patel D. White Paper on Key Barriers to Clinical Trials for Alzheimer's Disease. USC Schaeffer Center for Health Policy & Economics and Gates Ventures. August 2020. https://healthpolicy.usc.edu/wp-content/uploads/2020/08/Key-Barriers-to-Clinical-Trials-for-Alzheimer%E2%80%99s-Disease_FINAL.pdf. Accessed December 01, 2020.

Morris JC, Schindler SE, McCue LM, Moulder KL, Benzinger TLS, Cruchaga C, Fagan AM, Grant E, Gordon BA, Holtzman DM, Xiong C. Assessment of Racial Disparities in Biomarkers for Alzheimer Disease. JAMA Neurol. 2019 Mar 1;76(3):264-273. doi: 10.1001/jamaneurol.2018.4249.

Niemantsverdriet E, Valckx S, Bjerke M, Engelborghs S. Alzheimer's disease CSF biomarkers: clinical indications and rational use. Acta Neurol Belg. 2017 Sep;117(3):591-602. doi: 10.1007/s13760-017-0816-5. Epub 2017 Jul 27.

O'Bryant SE, Humphreys JD, Smith GE, Ivnik RJ, Graff-Radford NR, Petersen RC, Lucas JA. Detecting dementia with the mini-mental state examination in highly educated individuals. Arch Neurol. 2008 Jul;65(7):963-7. doi: 10.1001/archneur.65.7.963.

US Food and Drug Administration. De Novo Classification Request For Cognivue. De Novo Summary (DEN130033). www.accessdata.fda.gov/cdrh_docs/reviews/DEN130033.pdf. Accessed December 7, 2020.

Weiner MW, Veitch DP, Aisen PS, Beckett LA, Cairns NJ, Green RC, Harvey D, Jack CR Jr, Jagust W, Morris JC, Petersen RC, Saykin AJ, Shaw LM, Toga AW, Trojanowski JQ; Alzheimer's Disease Neuroimaging Initiative. Recent publications from the Alzheimer's Disease Neuroimaging Initiative: Reviewing progress toward improved AD clinical trials. Alzheimers Dement. 2017 Apr;13(4):e1-e85. doi: 10.1016/j.jalz.2016.11.007. Epub 2017 Mar 22.

Zhang J, Zhou W, Cassidy RM, Su H, Su Y, Zhang X; Alzheimer's Disease Neuroimaging Initiative. Risk factors for amyloid positivity in older people reporting significant memory concern. Compr Psychiatry. 2018 Jan;80:126-131. doi: 10.1016/j.comppsych.2017.09.015. Epub 2017 Oct 6.

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