Neuroinflammation and Alzheimer's Pathology in POCD

NCT05378659 | Unknown

• 1 other identifier: 4790
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to investigate the role of both neural inflammation and pre-existing neurodegenerative pathology in the risk and pathogenesis of post-operative cognitive dysfunction (POCD). To achieve this goal, the investigators will combine blood and cerebrospinal fluid (CSF) sampling, standardized cognitive tests, and dynamic neurophysiological markers of cortical network dysfunction in the form of event-related potentials (ERPs), to assess the link between neurodegeneration and neuroinflammation in the pathogenesis of POCD.

Conditions

Post-Operative Confusion; Neuroinflammatory Response; Alzheimer Disease

Keywords

POCD; Neuroinflammation

Outcome Measures

Primary Outcomes (42)

• Blood Interleukin-1 beta (IL-1β)

  A proinflammatory cytokine that activates astrocytes and micro ganglia

  Baseline

• Blood Interleukin-1 beta (IL-1β)

  A proinflammatory cytokine that activates astrocytes and micro ganglia

  Pre-op (pre-operation) -Visit 2- Day of surgery

• Blood Interleukin-1 beta (IL-1β)

  A proinflammatory cytokine that activates astrocytes and micro ganglia

  Post-op Visit 2- In recovery room up to 12 hours post surgery

• Blood Interleukin-1 beta (IL-1β)

  A proinflammatory cytokine that activates astrocytes and micro ganglia

  2 Week Post-op -Visit 4

• Blood Interleukin-1 beta (IL-1β)

  A proinflammatory cytokine that activates astrocytes and micro ganglia

  6 Week Post-op -Visit 5

• Blood Tumor necrosis factor alpha (TNF- α)

  A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases

  Baseline

• Blood Tumor necrosis factor alpha (TNF- α)

  A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases

  Pre-op- Visit 2- Day of surgery

• Blood Tumor necrosis factor alpha (TNF- α)

  A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases

  Post-op Visit 2- In recovery room up to 12 hours post surgery

• Blood Tumor necrosis factor alpha (TNF- α)

  A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases

  2-week Post-op Visit 4

• Blood Tumor necrosis factor alpha (TNF- α)

  A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases

  6-week Post-op Visit 5

• Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha)

  A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease

  Baseline

• Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha)

  A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease

  Pre-op Visit 2- Day of surgery

• Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha)

  A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease

  Post-op Visit 2- In recovery room up to 12 hours post surgery

• Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha)

  A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease

  2-week Post-op Visit 4

• Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha)

  A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease

  6- week Post-op Visit 5

• Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2)

  A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages

  Baseline

• Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2)

  A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages

  Pre-op Visit 2- Day of surgery

• Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2)

  A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages

  Post-op Visit 2- In recovery room up to 12 hours post surgery

• Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2)

  A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages

  2 week Post-op Visit 4

• Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2)

  A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages

  6 week- Post-op Visit 5

• Cerebral Spinal Fluid Phosphorylated Tau Protein

  A helical protein known to be a biomarker in the cerebral spinal fluid in brains with Alzheimer's Disease

  Pre-op Visit 2-Day of surgery

• ERP response amplitude

  Measurement of event related potentials in the brain

  6 Week post-op visit 5

• ERP response latency

  Measurement of event related potentials in the brain

  6 Week post-op visit 5

• ERP response amplitude

  Measurement of event related potentials in the brain

  6 Month post-op visit 6

• ERP response latency

  Measurement of event related potentials in the brain

  6 Month post-op visit 6

• Stroop Test

  A neurocognitive test used to assess cognitive interference. T-Scores are computed with scores above 40 being "normal."

  Baseline

• Stroop Test

  A neurocognitive test used to assess cognitive interference. T-Scores are computed with scores above 40 being "normal."

  Pre-op Visit 2- Day of surgery

• Stroop Test

  A neurocognitive test used to assess cognitive interference. T-Scores are computed with scores above 40 being "normal."

  2 Week post-op Visit 4

• Montreal Cognitive Assessment

  A neurocognitive test used to assess cognitive function across multiple domains. Scoring is on a scale from 0-30 with a score \>26 being normal.

  Baseline

• Montreal Cognitive Assessment

  A neurocognitive test used to assess cognitive function across multiple domains. Scoring is on a scale from 0-30 with a score \>26 being normal.

  Pre-op Visit 2- Day of surgery

• Blind Montreal Cognitive Assessment

  A neurocognitive test used to assess cognitive function across multiple domains. Scoring is on a scale from 0-22 with a score \>18 being normal.

  48 Hours post-op- Visit 3

• Montreal Cognitive Assessment

  A neurocognitive test used to assess cognitive function across multiple domains. Scoring is on a scale from 0-30 with a score \>26 being normal.

  2 Week post-op- Visit 4

• Oral Trail Making Test

  A neurocognitive test used to assess cognitive executive function with times for trail A \> 78 seconds and trail B \>273 seconds being deficient.

  Baseline

• Oral Trail Making Test

  A neurocognitive test used to assess cognitive executive function with times for trail A \> 78 seconds and trail B \>273 seconds being deficient.

  Pre-op Visit 2- Day of surgery

• Oral Trail Making Test

  A neurocognitive test used to assess cognitive executive function with times for trail A \> 78 seconds and trail B \>273 seconds being deficient.

  48 Hours post-op Visit 3

• Oral Trail Making Test

  A neurocognitive test used to assess cognitive executive function with times for trail A \> 78 seconds and trail B \>273 seconds being deficient.

  2- Week post-op Visit 4

• Symbol Digit Test

  A neurocognitive test used to assess for cerebral dysfunction scored through statistical methods with a higher score meaning higher cognitive vitality.

  Baseline

• Symbol Digit Test

  A neurocognitive test used to assess for cerebral dysfunction scored through statistical methods with a higher score meaning higher cognitive vitality.

  Pre-op Visit 2- Day of surgery

• Symbol Digit Test

  A neurocognitive test used to assess for cerebral dysfunction scored through statistical methods with a higher score meaning higher cognitive vitality.

  2- Week post-op Visit 4

• 4 AT Delirium Screening

  Bedside screening to detect delirium with a score of 4 or more indicating delirium +/- cognitive impairment, and a score of 1-3 indicating possible cognitive impairment.

  Post-op Visit 2- In recovery room up to 12 hours post surgery

• Grooved Pegboard Test

  A neurocognitive test consisting of varying key shapes and matching holes used to test visual motor coordination with a higher score indicating less or no impairment based on the individual's age and sex.

  6 month post-op Visit 6

• National Alzheimer's Coordinating Center Cognitive Battery

  Cognitive assessment to test for deficits across multiple domains with a score of 95/995 =physical problem; 96/996 = cognitive/behavioral problem

  6 month post-op Visit 6

Study Arms (2)

With Post-Operative Cognitive Dysfunction

Subjects determined to have post-operative cognitive dysfunction based on the results of: 1. 4AT Delirium Test 2. Scoring on : 1. Montreal Cognitive Assessment 2. Oral Trails Test 3. Stroop Test 4. Symbol Digit Modalities Test All subjects will undergo: 1. Blood sample collection 2. Cerebral spinal fluid collection 3. ERP testing 4. NACC Cognitive Battery 5. Grooved Pegboard testing

Behavioral: Montreal Cognitive Assessment; Behavioral: Stroop Test; Diagnostic Test: 4AT Delirium; Behavioral: Grooved Pegboard; Behavioral: NACC Cognitive Battery; Diagnostic Test: ERP Testing; Diagnostic Test: Blood Plasma and Serum sampling; Diagnostic Test: Cerebral Spinal Fluid Sample

Without Post-Operative Cognitive Dysfunction

Subjects determined to not have post-operative cognitive dysfunction based on the results of: 1. 4AT Delirium Test 2. Scoring on : 1. Montreal Cognitive Assessment 2. Oral Trails Test 3. Stroop Test 4. Symbol Digit Modalities Test All subjects will undergo: 1. Blood sample collection 2. Cerebral spinal fluid collection 3. ERP testing 4. NACC Cognitive Battery 5. Grooved Pegboard testing

Behavioral: Montreal Cognitive Assessment; Behavioral: Stroop Test; Diagnostic Test: 4AT Delirium; Behavioral: Grooved Pegboard; Behavioral: NACC Cognitive Battery; Diagnostic Test: ERP Testing; Diagnostic Test: Blood Plasma and Serum sampling; Diagnostic Test: Cerebral Spinal Fluid Sample

Interventions

Montreal Cognitive Assessment BEHAVIORAL

Cognitive evaluation of short term memory, visuospatial abilities, executive functioning, attention, concentration, working memory, language, and orientation to time and place

Also known as: MOCA

With Post-Operative Cognitive Dysfunction; Without Post-Operative Cognitive Dysfunction

Stroop Test BEHAVIORAL

Evaluates Processing Speed and Executive Control

With Post-Operative Cognitive Dysfunction; Without Post-Operative Cognitive Dysfunction

4AT Delirium DIAGNOSTIC_TEST

Screening tool to test for delirium post surgery

With Post-Operative Cognitive Dysfunction; Without Post-Operative Cognitive Dysfunction

Grooved Pegboard BEHAVIORAL

Evaluation testing for dominant and non dominant sensory-motor speed

With Post-Operative Cognitive Dysfunction; Without Post-Operative Cognitive Dysfunction

NACC Cognitive Battery BEHAVIORAL

A series of tests that evaluate attention, concentration, immediate verbal memory, immediate visual memory, discrimination, processing/motor speed, and validity and effort.

With Post-Operative Cognitive Dysfunction; Without Post-Operative Cognitive Dysfunction

ERP Testing DIAGNOSTIC_TEST

An event-related potential ( ERP) is the measured brain response that is the direct result of a specific sensory, cognitive, or motor event. More formally, it is any stereotyped electrophysiological response to a stimulus. The study of the brain in this way provides a noninvasive means of evaluating brain functioning.

With Post-Operative Cognitive Dysfunction; Without Post-Operative Cognitive Dysfunction

Blood Plasma and Serum sampling DIAGNOSTIC_TEST

Up to six 4 ml samples of both serum and plasma will be obtained to assess for inflammatory markers.

With Post-Operative Cognitive Dysfunction; Without Post-Operative Cognitive Dysfunction

Cerebral Spinal Fluid Sample DIAGNOSTIC_TEST

At the time the spinal is placed for anesthetic purposes, 2ml of cerebral spinal fluid will be obtained to assess for inflammatory markers.

With Post-Operative Cognitive Dysfunction; Without Post-Operative Cognitive Dysfunction

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No one ethnic group is either targeted or excluded in the proposed study. The investigators aim to target a sample of individuals ages 60 and older who will all undergo total knee arthroplasty. This selection of participants is based upon the aims of the current study. Due to the nature of the study, the investigators will include individuals with who are considered elderly. This population is necessary due to the increased prevalence of POCD within this group.

You may qualify if:

• Males and females 60 years or older in age
• Subjects scheduled to undergo TKA
• Fluent and literate in English
• Able to give consent for themselves based upon the MacArthur Competence Assessment Tool for Clinical Research
• Able to have a subarachnoid block with only intravenous sedation

You may not qualify if:

• Less than 60 years of age
• Cognitively impaired to the point where they are unable to give consent for themselves
• Blindness or partial blindness
• Pre-existing neurodegenerative conditions
• Contraindication for subarachnoid block and/or requiring general anesthesia

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead
• Alzheimer's Association: collaborator

Study Sites (1)

Robert M Craft

Knoxville, Tennessee, 37920, United States

RECRUITING

Related Publications (28)

• Daiello LA, Racine AM, Yun Gou R, Marcantonio ER, Xie Z, Kunze LJ, Vlassakov KV, Inouye SK, Jones RN, Alsop D, Travison T, Arnold S, Cooper Z, Dickerson B, Fong T, Metzger E, Pascual-Leone A, Schmitt EM, Shafi M, Cavallari M, Dai W, Dillon ST, McElhaney J, Guttmann C, Hshieh T, Kuchel G, Libermann T, Ngo L, Press D, Saczynski J, Vasunilashorn S, O'Connor M, Kimchi E, Strauss J, Wong B, Belkin M, Ayres D, Callery M, Pomposelli F, Wright J, Schermerhorn M, Abrantes T, Albuquerque A, Bertrand S, Brown A, Callahan A, D'Aquila M, Dowal S, Fox M, Gallagher J, Anna Gersten R, Hodara A, Helfand B, Inloes J, Kettell J, Kuczmarska A, Nee J, Nemeth E, Ochsner L, Palihnich K, Parisi K, Puelle M, Rastegar S, Vella M, Xu G, Bryan M, Guess J, Enghorn D, Gross A, Gou Y, Habtemariam D, Isaza I, Kosar C, Rockett C, Tommet D, Gruen T, Ross M, Tasker K, Gee J, Kolanowski A, Pisani M, de Rooij S, Rogers S, Studenski S, Stern Y, Whittemore A, Gottlieb G, Orav J, Sperling R; SAGES Study Group*. Postoperative Delirium and Postoperative Cognitive Dysfunction: Overlap and Divergence. Anesthesiology. 2019 Sep;131(3):477-491. doi: 10.1097/ALN.0000000000002729.

  PMID: 31166241 BACKGROUND

• O' Brien H, Mohan H, Hare CO, Reynolds JV, Kenny RA. Mind Over Matter? The Hidden Epidemic of Cognitive Dysfunction in the Older Surgical Patient. Ann Surg. 2017 Apr;265(4):677-691. doi: 10.1097/SLA.0000000000001900.

  PMID: 27537541 BACKGROUND

• Chen MH, Liao Y, Rong PF, Hu R, Lin GX, Ouyang W. Hippocampal volume reduction in elderly patients at risk for postoperative cognitive dysfunction. J Anesth. 2013 Aug;27(4):487-92. doi: 10.1007/s00540-012-1548-6. Epub 2013 Jan 31.

  PMID: 23371369 BACKGROUND

• Pappa M, Theodosiadis N, Tsounis A, Sarafis P. Pathogenesis and treatment of post-operative cognitive dysfunction. Electron Physician. 2017 Feb 25;9(2):3768-3775. doi: 10.19082/3768. eCollection 2017 Feb.

  PMID: 28465805 BACKGROUND

• Xiao QX, Liu Q, Deng R, Gao ZW, Zhang Y. Postoperative cognitive dysfunction in elderly patients undergoing hip arthroplasty. Psychogeriatrics. 2020 Jul;20(4):501-509. doi: 10.1111/psyg.12516. Epub 2020 Jan 24.

  PMID: 31976614 BACKGROUND

• Feinkohl I, Winterer G, Spies CD, Pischon T. Cognitive Reserve and the Risk of Postoperative Cognitive Dysfunction. Dtsch Arztebl Int. 2017 Feb 17;114(7):110-117. doi: 10.3238/arztebl.2017.0110.

  PMID: 28302254 BACKGROUND

• Evered L, Scott DA, Silbert B, Maruff P. Postoperative cognitive dysfunction is independent of type of surgery and anesthetic. Anesth Analg. 2011 May;112(5):1179-85. doi: 10.1213/ANE.0b013e318215217e. Epub 2011 Apr 7.

  PMID: 21474666 BACKGROUND

• Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22 Suppl 3:67-79. doi: 10.3233/JAD-2010-101086.

  PMID: 20858956 BACKGROUND

• Edipoglu IS, Celik F. The Associations Between Cognitive Dysfunction, Stress Biomarkers, and Administered Anesthesia Type in Total Knee Arthroplasties: Prospective, Randomized Trial. Pain Physician. 2019 Sep;22(5):495-507.

  PMID: 31561651 BACKGROUND

• Bekker A, Lee C, de Santi S, Pirraglia E, Zaslavsky A, Farber S, Haile M, de Leon MJ. Does mild cognitive impairment increase the risk of developing postoperative cognitive dysfunction? Am J Surg. 2010 Jun;199(6):782-8. doi: 10.1016/j.amjsurg.2009.07.042.

  PMID: 20609722 BACKGROUND

• Silbert B, Evered L, Scott DA, McMahon S, Choong P, Ames D, Maruff P, Jamrozik K. Preexisting cognitive impairment is associated with postoperative cognitive dysfunction after hip joint replacement surgery. Anesthesiology. 2015 Jun;122(6):1224-34. doi: 10.1097/ALN.0000000000000671.

  PMID: 25859906 BACKGROUND

• Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.

  PMID: 9525362 BACKGROUND

• Luo A, Yan J, Tang X, Zhao Y, Zhou B, Li S. Postoperative cognitive dysfunction in the aged: the collision of neuroinflammaging with perioperative neuroinflammation. Inflammopharmacology. 2019 Feb;27(1):27-37. doi: 10.1007/s10787-018-00559-0. Epub 2019 Jan 3.

  PMID: 30607668 BACKGROUND

• Simen AA, Bordner KA, Martin MP, Moy LA, Barry LC. Cognitive dysfunction with aging and the role of inflammation. Ther Adv Chronic Dis. 2011 May;2(3):175-95. doi: 10.1177/2040622311399145.

  PMID: 23251749 BACKGROUND

• Ortega-Gomez A, Perretti M, Soehnlein O. Resolution of inflammation: an integrated view. EMBO Mol Med. 2013 May;5(5):661-74. doi: 10.1002/emmm.201202382. Epub 2013 Apr 17.

  PMID: 23592557 BACKGROUND

• Ferretti MT, Cuello AC. Does a pro-inflammatory process precede Alzheimer's disease and mild cognitive impairment? Curr Alzheimer Res. 2011 Mar;8(2):164-74. doi: 10.2174/156720511795255982.

  PMID: 21345170 BACKGROUND

• Meraz-Rios MA, Toral-Rios D, Franco-Bocanegra D, Villeda-Hernandez J, Campos-Pena V. Inflammatory process in Alzheimer's Disease. Front Integr Neurosci. 2013 Aug 13;7:59. doi: 10.3389/fnint.2013.00059. eCollection 2013.

  PMID: 23964211 BACKGROUND

• Hu Z, Ou Y, Duan K, Jiang X. Inflammation: a bridge between postoperative cognitive dysfunction and Alzheimer's disease. Med Hypotheses. 2010 Apr;74(4):722-4. doi: 10.1016/j.mehy.2009.10.040. Epub 2009 Nov 26.

  PMID: 19944539 BACKGROUND

• Andreasen N, Hesse C, Davidsson P, Minthon L, Wallin A, Winblad B, Vanderstichele H, Vanmechelen E, Blennow K. Cerebrospinal fluid beta-amyloid(1-42) in Alzheimer disease: differences between early- and late-onset Alzheimer disease and stability during the course of disease. Arch Neurol. 1999 Jun;56(6):673-80. doi: 10.1001/archneur.56.6.673.

  PMID: 10369305 BACKGROUND

• Evered L, Silbert B, Scott DA, Ames D, Maruff P, Blennow K. Cerebrospinal Fluid Biomarker for Alzheimer Disease Predicts Postoperative Cognitive Dysfunction. Anesthesiology. 2016 Feb;124(2):353-61. doi: 10.1097/ALN.0000000000000953.

  PMID: 26580833 BACKGROUND

• Wu Z, Zhang M, Zhang Z, Dong W, Wang Q, Ren J. Ratio of beta-amyloid protein (Abeta) and Tau predicts the postoperative cognitive dysfunction on patients undergoing total hip/knee replacement surgery. Exp Ther Med. 2018 Jan;15(1):878-884. doi: 10.3892/etm.2017.5480. Epub 2017 Nov 10.

  PMID: 29399093 BACKGROUND

• Xie Z, McAuliffe S, Swain CA, Ward SA, Crosby CA, Zheng H, Sherman J, Dong Y, Zhang Y, Sunder N, Burke D, Washicosky KJ, Tanzi RE, Marcantonio ER. Cerebrospinal fluid abeta to tau ratio and postoperative cognitive change. Ann Surg. 2013 Aug;258(2):364-9. doi: 10.1097/SLA.0b013e318298b077.

  PMID: 23732272 BACKGROUND

• Shi HJ, Xue XH, Wang YL, Zhang WS, Wang ZS, Yu AL. Effects of different anesthesia methods on cognitive dysfunction after hip replacement operation in elder patients. Int J Clin Exp Med. 2015 Mar 15;8(3):3883-8. eCollection 2015.

  PMID: 26064288 BACKGROUND

• Gaetani L, Blennow K, Calabresi P, Di Filippo M, Parnetti L, Zetterberg H. Neurofilament light chain as a biomarker in neurological disorders. J Neurol Neurosurg Psychiatry. 2019 Aug;90(8):870-881. doi: 10.1136/jnnp-2018-320106. Epub 2019 Apr 9.

  PMID: 30967444 BACKGROUND

• Niikado M, Chrem-Mendez P, Itzcovich T, Barbieri-Kennedy M, Calandri I, Martinetto H, Serra M, Calvar J, Campos J, Russo MJ, Pertierra L, Allegri R, Sevlever G, Surace EI. Evaluation of Cerebrospinal Fluid Neurofilament Light Chain as a Routine Biomarker in a Memory Clinic. J Gerontol A Biol Sci Med Sci. 2019 Mar 14;74(4):442-445. doi: 10.1093/gerona/gly179.

  PMID: 30107413 BACKGROUND

• Frisoni GB, Fox NC, Jack CR Jr, Scheltens P, Thompson PM. The clinical use of structural MRI in Alzheimer disease. Nat Rev Neurol. 2010 Feb;6(2):67-77. doi: 10.1038/nrneurol.2009.215.

  PMID: 20139996 BACKGROUND

• Galvao-Carmona A, Gonzalez-Rosa JJ, Hidalgo-Munoz AR, Paramo D, Benitez ML, Izquierdo G, Vazquez-Marrufo M. Disentangling the attention network test: behavioral, event related potentials, and neural source analyses. Front Hum Neurosci. 2014 Oct 13;8:813. doi: 10.3389/fnhum.2014.00813. eCollection 2014.

  PMID: 25352800 BACKGROUND

• McMackin R, Bede P, Pender N, Hardiman O, Nasseroleslami B. Neurophysiological markers of network dysfunction in neurodegenerative diseases. Neuroimage Clin. 2019;22:101706. doi: 10.1016/j.nicl.2019.101706. Epub 2019 Feb 2.

  PMID: 30738372 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and cerebrospinal fluid.

MeSH Terms

Conditions

Alzheimer Disease; Neuroinflammatory Diseases

Interventions

Mental Status and Dementia Tests; Stroop Test

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Robert M Craft, MD

  University of Tennessee Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Department of Anesthesiology Chair

CONTACT

8653059220; rcraft@utmck.edu

Aimee Pehrson, MPH

CONTACT

8653055432; apehrson@utmck.edu

Study Design

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

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 18, 2022
• Study Start: November 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators who proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

US (1)