US 12,405,268 B2
Lymphocyte-based morphometric test for alzheimer's disease
Florin Valentin Chirila, Morgantown, WV (US); and Daniel L. Alkon, Chevy Chase, MD (US)
Assigned to NeuroDiagnostics LLC, Rockville, MD (US)
Filed by NeuroDiagnostics LLC, Rockville, MD (US)
Filed on Jul. 26, 2022, as Appl. No. 17/873,344.
Application 17/873,344 is a continuation of application No. 15/939,948, filed on Mar. 29, 2018, granted, now 11,415,574.
Claims priority of provisional application 62/479,630, filed on Mar. 31, 2017.
Prior Publication US 2022/0357315 A1, Nov. 10, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/50 (2006.01); G01N 33/68 (2006.01)
CPC G01N 33/5091 (2013.01) [G01N 33/5032 (2013.01); G01N 33/5052 (2013.01); G01N 2800/2821 (2013.01); G01N 2800/50 (2013.01)] 14 Claims
 
1. A method for diagnosing Alzheimer's disease in a symptomatic human subject comprising the steps of (a) culturing B lymphocytes from the subject with a suitable basement membrane matrix for a duration and under conditions sufficient to permit the lymphocytes to aggregate; (b) measuring the percent aggregate area of the resulting lymphocyte aggregation; and (c) comparing the measurement of step (b) with a suitable control, thereby determining whether the subject is afflicted with Alzheimer's disease, wherein (i) the culturing step (a) comprises seeding the lymphocytes at a density between 125 cells/μl and 250 cells/μl, and (ii) the duration sufficient to permit the lymphocytes to aggregate is selected from the group consisting of between 30 minutes and two hours, between 30 minutes and four hours, between 30 minutes and eight hours, between 30 minutes and 12 hours, between 30 minutes and 24 hours, between two hours and four hours, between two hours and eight hours, between two hours and 12 hours, between two hours and 24 hours, between two hours and 48 hours, between four hours and eight hours, between four hours and 12 hours, between four hours and 24 hours, between four hours and 48 hours, between eight hours and 12 hours, between eight hours and 24 hours, between eight hours and 48 hours, between 12 hours and 24 hours, between 12 hours and 48 hours, and between 24 hours and 48 hours.