Biomarkers for Cognitive Decline in Intracerebral Hemorrhage

NCT06836141 | Recruiting

• 2 other identifiers: 230224011R01NS135614-01A1
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to see if silent brain infarcts (SBIs), or stroke-like symptoms detectable during brain imaging, are a possible contributor to cognitive decline for patients diagnosed with spontaneous intracerebral hemorrhage (sICH), or blood clot in the brain. The main questions it aims to answer are

• if SBIs in sICH are associated with a lower cognitive level and more rapid cognitive decline
• if SBIs in sICH are associated with certain findings on brain imaging
• if SBIs in sICH are associated with higher inflammation measured by certain blood tests Participants will undergo
• cognitive testing during hospitalization, and at 3, 6 and 12 months after the sICH
• Magnetic Resonance Imaging (MRI) of the brain during hospitalization and 12 months after the sICH
• blood draws during hospitalization and at 3, 6 and 12 months after the sICH

Conditions

Primary Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (9)

• Global Cognition

  Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery

  From date of randomization and assessed throughout the during hospitalization for qualifying ICH event up to 12 months

• Global Cognition

  Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery

  3 months after hospitalization

• Global Cognition

  Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery

  6 months after hospitalization

• Global Cognition

  Assessed via the the Late Onset Alzheimer's Disease Family Study Cognitive Battery

  12 months after hospitalization

• Absolute volumetric change in White Matter Hyperintensity (WMH)

  Uses a novel imaging analysis algorithm on serial 3-Tesla brain MRI

  from MRI at hospitalization to MRI at 12 months

• Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels

  compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative groups

  From date of consent and assessed during hospitalization for qualifying ICH event up to 12 months

• Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels

  compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative

  3 months after hospital discharge

• Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels

  compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative

  6 months after hospital discharge

• Serum soluble urokinase-type plasminogen activator receptor (suPAR) levels

  compare SuPAR levels between the silent brain infarct (SBI) positive and the SBI negative

  12 months after hospital discharge

Interventions

MRI DIAGNOSTIC_TEST

MRI during hospitalization and at 12 months post sICH

Blood Draw DIAGNOSTIC_TEST

Will occur during hospitalization and at 3, 6 and 12 months post sICH

Cognitive Test DIAGNOSTIC_TEST

Cognitive testing will occur during hospitalization and at 3, 6 and 12 months post sICH

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to Rush University Medical Center with an intracerebral hemorrhage.

You may qualify if:

• Primary Intracerebral Hemorrhage
• Age ≥ 18 and \< 80 years

You may not qualify if:

• ICH score \> 2
• Pre-existing dementia
• Prior history of stroke
• Neurosurgical evacuation of hematoma

Sponsors & Collaborators

• Rush University Medical Center: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60614, United States

RECRUITING

Related Publications (52)

• Greenberg SM, Ziai WC, Cordonnier C, Dowlatshahi D, Francis B, Goldstein JN, Hemphill JC 3rd, Johnson R, Keigher KM, Mack WJ, Mocco J, Newton EJ, Ruff IM, Sansing LH, Schulman S, Selim MH, Sheth KN, Sprigg N, Sunnerhagen KS; American Heart Association/American Stroke Association. 2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2022 Jul;53(7):e282-e361. doi: 10.1161/STR.0000000000000407. Epub 2022 May 17. No abstract available.

  PMID: 35579034 BACKGROUND

• Hemorrhagic Stroke Academia Industry (HEADS) Roundtable Participants; Second HEADS Roundtable Participants. Recommendations for Clinical Trials in ICH: The Second Hemorrhagic Stroke Academia Industry Roundtable. Stroke. 2020 Apr;51(4):1333-1338. doi: 10.1161/STROKEAHA.119.027882. Epub 2020 Feb 10. No abstract available.

  PMID: 32078490 BACKGROUND

• Hwang DY, Kim KS, Muehlschlegel S, Wartenberg KE, Rajajee V, Alexander SA, Busl KM, Creutzfeldt CJ, Fontaine GV, Hocker SE, Madzar D, Mahanes D, Mainali S, Sakowitz OW, Varelas PN, Weimar C, Westermaier T, Meixensberger J. Guidelines for Neuroprognostication in Critically Ill Adults with Intracerebral Hemorrhage. Neurocrit Care. 2024 Apr;40(2):395-414. doi: 10.1007/s12028-023-01854-7. Epub 2023 Nov 3.

  PMID: 37923968 BACKGROUND

• Smith HW, Marshall CJ. Regulation of cell signalling by uPAR. Nat Rev Mol Cell Biol. 2010 Jan;11(1):23-36. doi: 10.1038/nrm2821.

  PMID: 20027185 BACKGROUND

• Nikorowitsch J, Borchardt T, Appelbaum S, Ojeda F, Lackner KJ, Schnabel RB, Blankenberg S, Zeller T, Karakas M. Cardio-Renal Biomarker Soluble Urokinase-Type Plasminogen Activator Receptor Is Associated With Cardiovascular Death and Myocardial Infarction in Patients With Coronary Artery Disease Independent of Troponin, C-Reactive Protein, and Renal Function. J Am Heart Assoc. 2020 Apr 21;9(8):e015452. doi: 10.1161/JAHA.119.015452. Epub 2020 Apr 17.

  PMID: 32299288 BACKGROUND

• Wilson RS, Yu L, Lamar M, Schneider JA, Boyle PA, Bennett DA. Education and cognitive reserve in old age. Neurology. 2019 Mar 5;92(10):e1041-e1050. doi: 10.1212/WNL.0000000000007036. Epub 2019 Feb 6.

  PMID: 30728309 BACKGROUND

• Garg RK, Khan J, Dawe RJ, Conners J, John S, Prabhakaran S, Kocak M, Bhabad S, Simpson SL, Ouyang B, Jhaveri M, Bleck TP. The Influence of Diffusion Weighted Imaging Lesions on Outcomes in Patients with Acute Spontaneous Intracerebral Hemorrhage. Neurocrit Care. 2020 Oct;33(2):552-564. doi: 10.1007/s12028-020-00933-3.

  PMID: 32072457 BACKGROUND

• Grosu S, Rospleszcz S, Hartmann F, Habes M, Bamberg F, Schlett CL, Galie F, Lorbeer R, Auweter S, Selder S, Buelow R, Heier M, Rathmann W, Mueller-Peltzer K, Ladwig KH, Grabe HJ, Peters A, Ertl-Wagner BB, Stoecklein S. Associated factors of white matter hyperintensity volume: a machine-learning approach. Sci Rep. 2021 Jan 27;11(1):2325. doi: 10.1038/s41598-021-81883-4.

  PMID: 33504924 BACKGROUND

• Greenberg SM, O'Donnell HC, Schaefer PW, Kraft E. MRI detection of new hemorrhages: potential marker of progression in cerebral amyloid angiopathy. Neurology. 1999 Sep 22;53(5):1135-8. doi: 10.1212/wnl.53.5.1135.

  PMID: 10496283 BACKGROUND

• Maclullich AM, Wardlaw JM, Ferguson KJ, Starr JM, Seckl JR, Deary IJ. Enlarged perivascular spaces are associated with cognitive function in healthy elderly men. J Neurol Neurosurg Psychiatry. 2004 Nov;75(11):1519-23. doi: 10.1136/jnnp.2003.030858.

  PMID: 15489380 BACKGROUND

• Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.

  PMID: 19414839 BACKGROUND

• Chew-Harris J, Appleby S, Richards AM, Troughton RW, Pemberton CJ. Analytical, biochemical and clearance considerations of soluble urokinase plasminogen activator receptor (suPAR) in healthy individuals. Clin Biochem. 2019 Jul;69:36-44. doi: 10.1016/j.clinbiochem.2019.05.010. Epub 2019 May 23.

  PMID: 31129182 BACKGROUND

• Eugen-Olsen J, Ladelund S, Sorensen LT. Plasma suPAR is lowered by smoking cessation: a randomized controlled study. Eur J Clin Invest. 2016 Apr;46(4):305-11. doi: 10.1111/eci.12593. Epub 2016 Feb 19.

  PMID: 26799247 BACKGROUND

• Haupt TH, Kallemose T, Ladelund S, Rasmussen LJ, Thorball CW, Andersen O, Pisinger C, Eugen-Olsen J. Risk factors associated with serum levels of the inflammatory biomarker soluble urokinase plasminogen activator receptor in a general population. Biomark Insights. 2014 Dec 16;9:91-100. doi: 10.4137/BMI.S19876. eCollection 2014.

  PMID: 25574132 BACKGROUND

• Mehta A, Desai SR, Ko YA, Liu C, Dhindsa DS, Nayak A, Hooda A, Martini MA, Ejaz K, Sperling LS, Reiser J, Hayek SS, Quyyumi AA. Sex Differences in Circulating Soluble Urokinase-Type Plasminogen Activator Receptor (suPAR) Levels and Adverse Outcomes in Coronary Artery Disease. J Am Heart Assoc. 2020 Mar 3;9(5):e015457. doi: 10.1161/JAHA.119.015457. Epub 2020 Feb 22.

  PMID: 32089048 BACKGROUND

• Chen X, Jin Y, Chen J, Chen X, Cao X, Yu L, Xu Y. Relationship between White Matter Hyperintensities and Hematoma Volume in Patients with Intracerebral Hematoma. Aging Dis. 2018 Dec 4;9(6):999-1009. doi: 10.14336/AD.2018.0108. eCollection 2018 Dec.

  PMID: 30574413 BACKGROUND

• Dickie DA, Ritchie SJ, Cox SR, Sakka E, Royle NA, Aribisala BS, Valdes Hernandez Mdel C, Maniega SM, Pattie A, Corley J, Starr JM, Bastin ME, Deary IJ, Wardlaw JM. Vascular risk factors and progression of white matter hyperintensities in the Lothian Birth Cohort 1936. Neurobiol Aging. 2016 Jun;42:116-23. doi: 10.1016/j.neurobiolaging.2016.03.011. Epub 2016 Mar 21.

  PMID: 27143428 BACKGROUND

• Zheng K, Wang Z, Chen X, Chen J, Fu Y, Chen Q. Analysis of Risk Factors for White Matter Hyperintensity in Older Adults without Stroke. Brain Sci. 2023 May 22;13(5):835. doi: 10.3390/brainsci13050835.

  PMID: 37239307 BACKGROUND

• Scharf EL, Graff-Radford J, Przybelski SA, Lesnick TG, Mielke MM, Knopman DS, Preboske GM, Schwarz CG, Senjem ML, Gunter JL, Machulda M, Kantarci K, Petersen RC, Jack CR Jr, Vemuri P. Cardiometabolic Health and Longitudinal Progression of White Matter Hyperintensity: The Mayo Clinic Study of Aging. Stroke. 2019 Nov;50(11):3037-3044. doi: 10.1161/STROKEAHA.119.025822. Epub 2019 Sep 12.

  PMID: 31510903 BACKGROUND

• Debette S, Seshadri S, Beiser A, Au R, Himali JJ, Palumbo C, Wolf PA, DeCarli C. Midlife vascular risk factor exposure accelerates structural brain aging and cognitive decline. Neurology. 2011 Aug 2;77(5):461-8. doi: 10.1212/WNL.0b013e318227b227.

  PMID: 21810696 BACKGROUND

• van Dijk EJ, Prins ND, Vrooman HA, Hofman A, Koudstaal PJ, Breteler MM. Progression of cerebral small vessel disease in relation to risk factors and cognitive consequences: Rotterdam Scan study. Stroke. 2008 Oct;39(10):2712-9. doi: 10.1161/STROKEAHA.107.513176. Epub 2008 Jul 17.

  PMID: 18635849 BACKGROUND

• Power MC, Deal JA, Sharrett AR, Jack CR Jr, Knopman D, Mosley TH, Gottesman RF. Smoking and white matter hyperintensity progression: the ARIC-MRI Study. Neurology. 2015 Feb 24;84(8):841-8. doi: 10.1212/WNL.0000000000001283. Epub 2015 Jan 28.

  PMID: 25632094 BACKGROUND

• Posener S, Hmeydia G, Benzakoun J, Oppenheim C, Baron JC, Turc G. Remote Diffusion-Weighted Imaging Lesions and Intracerebral Hemorrhage: A Systematic Review and Meta-Analysis. Stroke. 2023 Apr;54(4):e133-e137. doi: 10.1161/STROKEAHA.122.040689. Epub 2023 Mar 3.

  PMID: 36866676 BACKGROUND

• Bennett DA, De Jager PL, Leurgans SE, Schneider JA. Neuropathologic intermediate phenotypes enhance association to Alzheimer susceptibility alleles. Neurology. 2009 Apr 28;72(17):1495-503. doi: 10.1212/WNL.0b013e3181a2e87d.

  PMID: 19398704 BACKGROUND

• Gong L, Gu Y, Yu Q, Wang H, Zhu X, Dong Q, Xu R, Zhao Y, Liu X. Prognostic Factors for Cognitive Recovery Beyond Early Poststroke Cognitive Impairment (PSCI): A Prospective Cohort Study of Spontaneous Intracerebral Hemorrhage. Front Neurol. 2020 Apr 28;11:278. doi: 10.3389/fneur.2020.00278. eCollection 2020.

  PMID: 32411073 BACKGROUND

• Case NF, Charlton A, Zwiers A, Batool S, McCreary CR, Hogan DB, Ismail Z, Zerna C, Coutts SB, Frayne R, Goodyear B, Haffenden A, Smith EE. Cerebral Amyloid Angiopathy Is Associated With Executive Dysfunction and Mild Cognitive Impairment. Stroke. 2016 Aug;47(8):2010-6. doi: 10.1161/STROKEAHA.116.012999. Epub 2016 Jun 23.

  PMID: 27338926 BACKGROUND

• Schmidt FA, Liotta EM, Prabhakaran S, Naidech AM, Maas MB. Assessment and comparison of the max-ICH score and ICH score by external validation. Neurology. 2018 Sep 4;91(10):e939-e946. doi: 10.1212/WNL.0000000000006117. Epub 2018 Aug 1.

  PMID: 30068631 BACKGROUND

• Hemphill JC 3rd, Bonovich DC, Besmertis L, Manley GT, Johnston SC. The ICH score: a simple, reliable grading scale for intracerebral hemorrhage. Stroke. 2001 Apr;32(4):891-7. doi: 10.1161/01.str.32.4.891.

  PMID: 11283388 BACKGROUND

• Pisani MA, Inouye SK, McNicoll L, Redlich CA. Screening for preexisting cognitive impairment in older intensive care unit patients: use of proxy assessment. J Am Geriatr Soc. 2003 May;51(5):689-93. doi: 10.1034/j.1600-0579.2003.00215.x.

  PMID: 12752846 BACKGROUND

• Prabhakaran S, Gupta R, Ouyang B, John S, Temes RE, Mohammad Y, Lee VH, Bleck TP. Acute brain infarcts after spontaneous intracerebral hemorrhage: a diffusion-weighted imaging study. Stroke. 2010 Jan;41(1):89-94. doi: 10.1161/STROKEAHA.109.566257. Epub 2009 Nov 5.

  PMID: 19892994 BACKGROUND

• Gupta A, Giambrone AE, Gialdini G, Finn C, Delgado D, Gutierrez J, Wright C, Beiser AS, Seshadri S, Pandya A, Kamel H. Silent Brain Infarction and Risk of Future Stroke: A Systematic Review and Meta-Analysis. Stroke. 2016 Mar;47(3):719-25. doi: 10.1161/STROKEAHA.115.011889.

  PMID: 26888534 BACKGROUND

• Charidimou A, Boulouis G, Frosch MP, Baron JC, Pasi M, Albucher JF, Banerjee G, Barbato C, Bonneville F, Brandner S, Calviere L, Caparros F, Casolla B, Cordonnier C, Delisle MB, Deramecourt V, Dichgans M, Gokcal E, Herms J, Hernandez-Guillamon M, Jager HR, Jaunmuktane Z, Linn J, Martinez-Ramirez S, Martinez-Saez E, Mawrin C, Montaner J, Moulin S, Olivot JM, Piazza F, Puy L, Raposo N, Rodrigues MA, Roeber S, Romero JR, Samarasekera N, Schneider JA, Schreiber S, Schreiber F, Schwall C, Smith C, Szalardy L, Varlet P, Viguier A, Wardlaw JM, Warren A, Wollenweber FA, Zedde M, van Buchem MA, Gurol ME, Viswanathan A, Al-Shahi Salman R, Smith EE, Werring DJ, Greenberg SM. The Boston criteria version 2.0 for cerebral amyloid angiopathy: a multicentre, retrospective, MRI-neuropathology diagnostic accuracy study. Lancet Neurol. 2022 Aug;21(8):714-725. doi: 10.1016/S1474-4422(22)00208-3.

  PMID: 35841910 BACKGROUND

• Jones WJ, Williams LS, Meschia JF. Validating the Questionnaire for Verifying Stroke-Free Status (QVSFS) by neurological history and examination. Stroke. 2001 Oct;32(10):2232-6. doi: 10.1161/hs1001.096191.

  PMID: 11588306 BACKGROUND

• Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2.

  PMID: 34022170 BACKGROUND

• Wei C, El Hindi S, Li J, Fornoni A, Goes N, Sageshima J, Maiguel D, Karumanchi SA, Yap HK, Saleem M, Zhang Q, Nikolic B, Chaudhuri A, Daftarian P, Salido E, Torres A, Salifu M, Sarwal MM, Schaefer F, Morath C, Schwenger V, Zeier M, Gupta V, Roth D, Rastaldi MP, Burke G, Ruiz P, Reiser J. Circulating urokinase receptor as a cause of focal segmental glomerulosclerosis. Nat Med. 2011 Jul 31;17(8):952-60. doi: 10.1038/nm.2411.

  PMID: 21804539 BACKGROUND

• Bifulco K, Longanesi-Cattani I, Gargiulo L, Maglio O, Cataldi M, De Rosa M, Stoppelli MP, Pavone V, Carriero MV. An urokinase receptor antagonist that inhibits cell migration by blocking the formyl peptide receptor. FEBS Lett. 2008 Apr 2;582(7):1141-6. doi: 10.1016/j.febslet.2008.03.001. Epub 2008 Mar 11.

  PMID: 18339322 BACKGROUND

• Azam TU, Shadid HR, Blakely P, O'Hayer P, Berlin H, Pan M, Zhao P, Zhao L, Pennathur S, Pop-Busui R, Altintas I, Tingleff J, Stauning MA, Andersen O, Adami ME, Solomonidi N, Tsilika M, Tober-Lau P, Arnaoutoglou E, Keitel V, Tacke F, Chalkias A, Loosen SH, Giamarellos-Bourboulis EJ, Eugen-Olsen J, Reiser J, Hayek SS; International Study of Inflammation in COVID-19. Soluble Urokinase Receptor (SuPAR) in COVID-19-Related AKI. J Am Soc Nephrol. 2020 Nov;31(11):2725-2735. doi: 10.1681/ASN.2020060829. Epub 2020 Sep 22.

  PMID: 32963090 BACKGROUND

• Botha S, Fourie CMT, Schutte R, Eugen-Olsen J, Pretorius R, Schutte AE. Soluble urokinase plasminogen activator receptor as a prognostic marker of all-cause and cardiovascular mortality in a black population. Int J Cardiol. 2015 Apr 1;184:631-636. doi: 10.1016/j.ijcard.2015.03.041. Epub 2015 Mar 4.

  PMID: 25771228 BACKGROUND

• Persson M, Ostling G, Smith G, Hamrefors V, Melander O, Hedblad B, Engstrom G. Soluble urokinase plasminogen activator receptor: a risk factor for carotid plaque, stroke, and coronary artery disease. Stroke. 2014 Jan;45(1):18-23. doi: 10.1161/STROKEAHA.113.003305. Epub 2013 Nov 19.

  PMID: 24253546 BACKGROUND

• Hayek SS, Leaf DE, Samman Tahhan A, Raad M, Sharma S, Waikar SS, Sever S, Camacho A, Wang X, Dande RR, Ibrahim NE, Baron RM, Altintas MM, Wei C, Sheikh-Hamad D, Pan JS, Holliday MW Jr, Januzzi JL, Weisbord SD, Quyyumi AA, Reiser J. Soluble Urokinase Receptor and Acute Kidney Injury. N Engl J Med. 2020 Jan 30;382(5):416-426. doi: 10.1056/NEJMoa1911481.

  PMID: 31995687 BACKGROUND

• Hayek SS, Sever S, Ko YA, Trachtman H, Awad M, Wadhwani S, Altintas MM, Wei C, Hotton AL, French AL, Sperling LS, Lerakis S, Quyyumi AA, Reiser J. Soluble Urokinase Receptor and Chronic Kidney Disease. N Engl J Med. 2015 Nov 12;373(20):1916-25. doi: 10.1056/NEJMoa1506362. Epub 2015 Nov 5.

  PMID: 26539835 BACKGROUND

• Timmermans K, Vaneker M, Scheffer GJ, Maassen P, Janssen S, Kox M, Pickkers P. Soluble urokinase-type plasminogen activator levels are related to plasma cytokine levels but have low predictive value for mortality in trauma patients. J Crit Care. 2015 Jun;30(3):476-80. doi: 10.1016/j.jcrc.2015.01.006. Epub 2015 Jan 9.

  PMID: 25721031 BACKGROUND

• Lyngbaek S, Marott JL, Moller DV, Christiansen M, Iversen KK, Clemmensen PM, Eugen-Olsen J, Jeppesen JL, Hansen PR. Usefulness of soluble urokinase plasminogen activator receptor to predict repeat myocardial infarction and mortality in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous intervention. Am J Cardiol. 2012 Dec 15;110(12):1756-63. doi: 10.1016/j.amjcard.2012.08.008. Epub 2012 Sep 13.

  PMID: 22981263 BACKGROUND

• Langkilde A, Jakobsen TL, Bandholm TQ, Eugen-Olsen J, Blauenfeldt T, Petersen J, Andersen O. Inflammation and post-operative recovery in patients undergoing total knee arthroplasty-secondary analysis of a randomized controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1265-1273. doi: 10.1016/j.joca.2017.03.008. Epub 2017 Mar 16.

  PMID: 28323139 BACKGROUND

• Llinas P, Le Du MH, Gardsvoll H, Dano K, Ploug M, Gilquin B, Stura EA, Menez A. Crystal structure of the human urokinase plasminogen activator receptor bound to an antagonist peptide. EMBO J. 2005 May 4;24(9):1655-63. doi: 10.1038/sj.emboj.7600635. Epub 2005 Apr 7.

  PMID: 15861141 BACKGROUND

• Biffi A, Bailey D, Anderson CD, Ayres AM, Gurol EM, Greenberg SM, Rosand J, Viswanathan A. Risk Factors Associated With Early vs Delayed Dementia After Intracerebral Hemorrhage. JAMA Neurol. 2016 Aug 1;73(8):969-76. doi: 10.1001/jamaneurol.2016.0955.

  PMID: 27295605 BACKGROUND

• Moulin S, Labreuche J, Bombois S, Rossi C, Boulouis G, Henon H, Duhamel A, Leys D, Cordonnier C. Dementia risk after spontaneous intracerebral haemorrhage: a prospective cohort study. Lancet Neurol. 2016 Jul;15(8):820-829. doi: 10.1016/S1474-4422(16)00130-7. Epub 2016 Apr 28.

  PMID: 27133238 BACKGROUND

• Schneider JA, Arvanitakis Z, Leurgans SE, Bennett DA. The neuropathology of probable Alzheimer disease and mild cognitive impairment. Ann Neurol. 2009 Aug;66(2):200-8. doi: 10.1002/ana.21706.

  PMID: 19743450 BACKGROUND

• Schneider JA, Arvanitakis Z, Bang W, Bennett DA. Mixed brain pathologies account for most dementia cases in community-dwelling older persons. Neurology. 2007 Dec 11;69(24):2197-204. doi: 10.1212/01.wnl.0000271090.28148.24. Epub 2007 Jun 13.

  PMID: 17568013 BACKGROUND

• Iadecola C, Duering M, Hachinski V, Joutel A, Pendlebury ST, Schneider JA, Dichgans M. Vascular Cognitive Impairment and Dementia: JACC Scientific Expert Panel. J Am Coll Cardiol. 2019 Jul 2;73(25):3326-3344. doi: 10.1016/j.jacc.2019.04.034.

  PMID: 31248555 BACKGROUND

• Zlokovic BV, Gottesman RF, Bernstein KE, Seshadri S, McKee A, Snyder H, Greenberg SM, Yaffe K, Schaffer CB, Yuan C, Hughes TM, Daemen MJ, Williamson JD, Gonzalez HM, Schneider J, Wellington CL, Katusic ZS, Stoeckel L, Koenig JI, Corriveau RA, Fine L, Galis ZS, Reis J, Wright JD, Chen J. Vascular contributions to cognitive impairment and dementia (VCID): A report from the 2018 National Heart, Lung, and Blood Institute and National Institute of Neurological Disorders and Stroke Workshop. Alzheimers Dement. 2020 Dec;16(12):1714-1733. doi: 10.1002/alz.12157. Epub 2020 Oct 8.

  PMID: 33030307 BACKGROUND

• Wilson RS, Leurgans SE, Foroud TM, Sweet RA, Graff-Radford N, Mayeux R, Bennett DA; National Institute on Aging Late-Onset Alzheimer's Disease Family Study Group. Telephone assessment of cognitive function in the late-onset Alzheimer's disease family study. Arch Neurol. 2010 Jul;67(7):855-61. doi: 10.1001/archneurol.2010.129.

  PMID: 20625093 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rajeev Garg, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Sremac, BS

CONTACT

312-942-0593; Amanda_C_Sremac@rush.edu

Rajeev Garg, MD

CONTACT

Rajeev_Garg@rush.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 20, 2025
• Study Start: August 2, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)