Michael Donohue

Michael Donohue

Professor of Neurology
ATR 9860 Mesa Rim Road Health Sciences Campus San Diego

Plasma Aß42/Aß40 and phospho-tau217 concentration ratios increase the accuracy of amyloid PET classification in preclinical Alzheimer's disease Alzheimers Dement. 2023 Nov 06. . View in PubMed

Ascertainment and Statistical Issues for Randomized Trials of Cardiovascular Interventions for Cognitive Impairment and Dementia: Dementia Series Hypertension. 2023 Sep 21. . View in PubMed

Trial of Solanezumab in Preclinical Alzheimer's Disease N Engl J Med. 2023 Sep 21; 389(12):1096-1107. . View in PubMed

Natural cubic splines for the analysis of Alzheimer's clinical trials Pharm Stat. 2023 May-Jun; 22(3):508-519. . View in PubMed

Safety and tolerability of lumbar puncture for the evaluation of Alzheimer's disease Alzheimers Dement (Amst). 2023 Apr-Jun; 15(2):e12431. . View in PubMed

Heterogeneity in Preclinical Alzheimer's Disease Trial Cohort Identified by Image-based Data-Driven Disease Progression Modelling medRxiv. 2023 Feb 10. . View in PubMed

The AHEAD 3-45 Study: Design of a prevention trial for Alzheimer's disease Alzheimers Dement. 2023 04; 19(4):1227-1233. . View in PubMed

Improving generalizability and study design of Alzheimer's disease cohort studies in the United States by including under-represented populations Alzheimers Dement. 2023 04; 19(4):1549-1557. . View in PubMed

Why a clinical trial is as good as its outcome measure: A framework for the selection and use of cognitive outcome measures for clinical trials of Alzheimer's disease Alzheimers Dement. 2023 02; 19(2):708-720. . View in PubMed

Evaluation of Blood-Based Plasma Biomarkers as Potential Markers of Amyloid Burden in Preclinical Alzheimer's Disease J Alzheimers Dis. 2023; 92(1):95-107. . View in PubMed

Tau positron emission tomography in preclinical Alzheimer's disease Brain. 2023 02 13; 146(2):700-711. . View in PubMed

Screening and enrollment of underrepresented ethnocultural and educational populations in the Alzheimer's Disease Neuroimaging Initiative (ADNI) Alzheimers Dement. 2022 Feb 25. . View in PubMed

Sensitivity of the Preclinical Alzheimer's Cognitive Composite (PACC), PACC5, and Repeatable Battery for Neuropsychological Status (RBANS) to Amyloid Status in Preclinical Alzheimer's Disease -Atabecestat Phase 2b/3 EARLY Clinical Trial J Prev Alzheimers Dis. 2022; 9(2):255-261. . View in PubMed

Amyloid-Related Imaging Abnormalities and Other MRI Findings in a Cognitively Unimpaired Population With and Without Cerebral Amyloid J Prev Alzheimers Dis. 2022; 9(4):617-624. . View in PubMed

Basal Infusion versus Automated Boluses and a Delayed Start Timer for "Continuous" Sciatic Nerve Blocks after Ambulatory Foot and Ankle Surgery: A Randomized Clinical Trial Anesthesiology. 2022 06 01; 136(6):970-982. . View in PubMed

Preoperative Ultrasound-guided Percutaneous Cryoneurolysis for the Treatment of Pain after Mastectomy: A Randomized, Participant- and Observer-masked, Sham-controlled Study Anesthesiology. 2022 11 01; 137(5):529-542. . View in PubMed

Serratus anterior plane versus paravertebral nerve blocks for postoperative analgesia after non-mastectomy breast surgery: a randomized controlled non-inferiority trial Reg Anesth Pain Med. 2021 09; 46(9):773-778. . View in PubMed

The Computerized Cognitive Composite (C3) in an Alzheimer's Disease Secondary Prevention Trial J Prev Alzheimers Dis. 2021; 8(1):59-67. . View in PubMed

Feasibility study for detection of retinal amyloid in clinical trials: The Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) trial Alzheimers Dement (Amst). 2021; 13(1):e12199. . View in PubMed

Time between milestone events in the Alzheimer's disease amyloid cascade Neuroimage. 2021 02 15; 227:117676. . View in PubMed

Item-Level Investigation of Participant and Study Partner Report on the Cognitive Function Index from the A4 Study Screening Data J Prev Alzheimers Dis. 2021; 8(3):257-262. . View in PubMed

Findings of Efficacy, Safety, and Biomarker Outcomes of Atabecestat in Preclinical Alzheimer Disease: A Truncated Randomized Phase 2b/3 Clinical Trial JAMA Neurol. 2021 03 01; 78(3):293-301. . View in PubMed

Predicting amyloid risk by machine learning algorithms based on the A4 screen data: Application to the Japanese Trial-Ready Cohort study Alzheimers Dement (N Y). 2021; 7(1):e12135. . View in PubMed

Response to: 'erector spinae plane and paravertebral blocks have similar opioid-sparing effects following breast surgery Reg Anesth Pain Med. 2020 Mar 26. . View in PubMed

Initiation of symptomatic medication in Alzheimer's disease clinical trials: Hypothetical versus treatment policy approach Alzheimers Dement. 2020 05; 16(5):797-803. . View in PubMed

The A4 study: ß-amyloid and cognition in 4432 cognitively unimpaired adults Ann Clin Transl Neurol. 2020 05; 7(5):776-785. . View in PubMed

Erector spinae plane versus paravertebral nerve blocks for postoperative analgesia after breast surgery: a randomized clinical trial Reg Anesth Pain Med. 2020 04; 45(4):260-266. . View in PubMed

Predicting Amyloid Burden to Accelerate Recruitment of Secondary Prevention Clinical Trials J Prev Alzheimers Dis. 2020; 7(4):213-218. . View in PubMed

Short-term Psychological Outcomes of Disclosing Amyloid Imaging Results to Research Participants Who Do Not Have Cognitive Impairment JAMA Neurol. 2020 12 01; 77(12):1504-1513. . View in PubMed

TRC-PAD: Accelerating Recruitment of AD Clinical Trials through Innovative Information Technology J Prev Alzheimers Dis. 2020; 7(4):226-233. . View in PubMed

The Trial-Ready Cohort for Preclinical/Prodromal Alzheimer's Disease (TRC-PAD) Project: An Overview J Prev Alzheimers Dis. 2020; 7(4):208-212. . View in PubMed

Effect of apolipoprotein E e4 allele on the progression of cognitive decline in the early stage of Alzheimer's disease Alzheimers Dement (N Y). 2020; 6(1):e12007. . View in PubMed

Instrumental activities of daily living, amyloid, and cognition in cognitively normal older adults screening for the A4 Study Alzheimers Dement (Amst). 2020; 12(1):e12118. . View in PubMed

Association of Factors With Elevated Amyloid Burden in Clinically Normal Older Individuals JAMA Neurol. 2020 06 01; 77(6):735-745. . View in PubMed

Neuroanatomical spread of amyloid ß and tau in Alzheimer's disease: implications for primary prevention Brain Commun. 2020; 2(1):fcaa007. . View in PubMed

Safety, Efficacy, and Feasibility of Intranasal Insulin for the Treatment of Mild Cognitive Impairment and Alzheimer Disease Dementia: A Randomized Clinical Trial JAMA Neurol. 2020 09 01; 77(9):1099-1109. . View in PubMed

Effect of AZD0530 on Cerebral Metabolic Decline in Alzheimer Disease: A Randomized Clinical Trial JAMA Neurol. 2019 Oct 01; 76(10):1219-1229. . View in PubMed

Predicting the course of Alzheimer's progression Brain Inform. 2019 Jun 28; 6(1):6. . View in PubMed

Continuous Popliteal-Sciatic Blocks for Postoperative Analgesia: Traditional Proximal Catheter Insertion Superficial to the Paraneural Sheath Versus a New Distal Insertion Site Deep to the Paraneural Sheath Anesth Analg. 2019 06; 128(6):e104-e108. . View in PubMed

A randomized clinical trial to evaluate home-based assessment of people over 75 years old Alzheimers Dement. 2019 05; 15(5):615-624. . View in PubMed

Predicting diagnosis and cognition with 18F-AV-1451 tau PET and structural MRI in Alzheimer's disease Alzheimers Dement. 2019 04; 15(4):570-580. . View in PubMed

Bayesian latent time joint mixed effect models for multicohort longitudinal data Stat Methods Med Res. 2019 03; 28(3):835-845. . View in PubMed

Plasma Neurofilament Light and Alzheimer's Disease Biomarkers in Down Syndrome: Results from the Down Syndrome Biomarker Initiative (DSBI) J Alzheimers Dis. 2019; 70(1):131-138. . View in PubMed

The relative efficiency of time-to-progression and continuous measures of cognition in presymptomatic Alzheimer's disease Alzheimers Dement (N Y). 2019; 5:308-318. . View in PubMed

Nonlinear Distributional Mapping (NoDiM) for harmonization across amyloid-PET radiotracers Neuroimage. 2019 02 01; 186:446-454. . View in PubMed

Participant satisfaction with dementia prevention research: Results from Home-Based Assessment trial Alzheimers Dement. 2018 11; 14(11):1397-1405. . View in PubMed

Sex, amyloid, and APOE e4 and risk of cognitive decline in preclinical Alzheimer's disease: Findings from three well-characterized cohorts Alzheimers Dement. 2018 09; 14(9):1193-1203. . View in PubMed

Response to Zywieck and Kirkby paper Neurobiol Aging. 2018 09; 69:298-299. . View in PubMed

Japanese and North American Alzheimer's Disease Neuroimaging Initiative studies: Harmonization for international trials Alzheimers Dement. 2018 08; 14(8):1077-1087. . View in PubMed

Anesth Analg. 2018 07; 127(1):240-246. . View in PubMed

Bayesian latent time joint mixed-effects model of progression in the Alzheimer's Disease Neuroimaging Initiative Alzheimers Dement (Amst). 2018; 10:657-668. . View in PubMed

Estimating the Evolution of Disease in the Parkinson's Progression Markers Initiative Neurodegener Dis. 2018; 18(4):173-190. . View in PubMed

Disease progression models for dominantly-inherited Alzheimer's disease Brain. 2018 05 01; 141(5):1244-1246. . View in PubMed

Defining the Optimal Target Population for Trials of Polyunsaturated Fatty Acid Supplementation Using the Erythrocyte Omega-3 Index: A Step Towards Personalized Prevention of Cognitive Decline? J Nutr Health Aging. 2018; 22(8):982-998.. View in PubMed

Early and late change on the preclinical Alzheimer's cognitive composite in clinically normal older individuals with elevated amyloid ß Alzheimers Dement. 2017 Sep; 13(9):1004-1012. . View in PubMed

Infection Rates of Electrical Leads Used for Percutaneous Neurostimulation of the Peripheral Nervous System Pain Pract. 2017 07; 17(6):753-762. . View in PubMed

Anesth Analg. 2017 04; 124(4):1298-1303. . View in PubMed

EU/US/CTAD Task Force: Lessons Learned from Recent and Current Alzheimer's Prevention Trials J Prev Alzheimers Dis. 2017; 4(2):116-124. . View in PubMed

Cross-validation of optimized composites for preclinical Alzheimer's disease Alzheimers Dement (N Y). 2017 Jan; 3(1):123-129. . View in PubMed

Elevated Brain Amyloid in Cognitively Normal Individuals-Reply JAMA. 2017 10 10; 318(14):1393-1394. . View in PubMed

Association Between Elevated Brain Amyloid and Subsequent Cognitive Decline Among Cognitively Normal Persons JAMA. 2017 06 13; 317(22):2305-2316. . View in PubMed

Anesth Analg. 2016 May; 122(5):1689-95. . View in PubMed

Cognitive and functional changes associated with Aß pathology and the progression to mild cognitive impairment Neurobiol Aging. 2016 12; 48:172-181. . View in PubMed

Using social and mobile tools for weight loss in overweight and obese young adults (Project SMART): a 2 year, parallel-group, randomised, controlled trial Lancet Diabetes Endocrinol. 2016 09; 4(9):747-755. . View in PubMed

Accelerating rates of cognitive decline and imaging markers associated with ß-amyloid pathology Neurology. 2016 05 17; 86(20):1887-96. . View in PubMed

Global Alzheimer's Platform Trial Ready Cohorts for the Prevention of Alzheimer's Dementia J Prev Alzheimers Dis. 2016; 3(4):185-187. . View in PubMed

The transitional association between ß-amyloid pathology and regional brain atrophy Alzheimers Dement. 2015 Oct; 11(10):1171-9. . View in PubMed

Longitudinal plasma amyloid beta in Alzheimer's disease clinical trials Alzheimers Dement. 2015 Sep; 11(9):1069-79. . View in PubMed

The Alzheimer's Disease Neuroimaging Initiative phase 2: Increasing the length, breadth, and depth of our understanding Alzheimers Dement. 2015 Jul; 11(7):823-31. . View in PubMed

Alzheimer's Disease Neuroimaging Initiative 2 Clinical Core: Progress and plans Alzheimers Dement. 2015 Jul; 11(7):734-9. . View in PubMed

Impact of the Alzheimer's Disease Neuroimaging Initiative, 2004 to 2014 Alzheimers Dement. 2015 Jul; 11(7):865-84. . View in PubMed

Predicting Reduction of Cerebrospinal Fluid ß-Amyloid 42 in Cognitively Healthy Controls JAMA Neurol. 2015 May; 72(5):554-60. . View in PubMed

Biomarkers and cognitive endpoints to optimize trials in Alzheimer's disease Ann Clin Transl Neurol. 2015 May; 2(5):534-47. . View in PubMed

Clinical trial management of participant recruitment, enrollment, engagement, and retention in the SMART study using a Marketing and Information Technology (MARKIT) model Contemp Clin Trials. 2015 May; 42:185-95. . View in PubMed

Tracking early decline in cognitive function in older individuals at risk for Alzheimer disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function Instrument JAMA Neurol. 2015 Apr; 72(4):446-54. . View in PubMed

Independent information from cerebrospinal fluid amyloid-ß and florbetapir imaging in Alzheimer's disease Brain. 2015 Mar; 138(Pt 3):772-83. . View in PubMed

A randomized, triple-masked, active-controlled investigation of the relative effects of dose, concentration, and infusion rate for continuous popliteal-sciatic nerve blocks in volunteers Br J Anaesth. 2015 Jan; 114(1):121-9. . View in PubMed

Impact of CRFR1 Ablation on Amyloid-ß Production and Accumulation in a Mouse Model of Alzheimer's Disease J Alzheimers Dis. 2015; 45(4):1175-84. . View in PubMed

The down syndrome biomarker initiative (DSBI) pilot: proof of concept for deep phenotyping of Alzheimer's disease biomarkers in down syndrome Front Behav Neurosci. 2015; 9:239. . View in PubMed

J Alzheimers Dis. 2015; 48(1):205-18. . View in PubMed

Estimating long-term multivariate progression from short-term data Alzheimers Dement. 2014 Oct; 10(5 Suppl):S400-10. . View in PubMed

Diagnostic accuracy of CSF Ab42 and florbetapir PET for Alzheimer's disease Ann Clin Transl Neurol. 2014 Aug; 1(8):534-43. . View in PubMed

The preclinical Alzheimer cognitive composite: measuring amyloid-related decline JAMA Neurol. 2014 Aug; 71(8):961-70. . View in PubMed

Emerging ß-amyloid pathology and accelerated cortical atrophy JAMA Neurol. 2014 Jun; 71(6):725-34. . View in PubMed

Association of brain amyloid-ß with cerebral perfusion and structure in Alzheimer's disease and mild cognitive impairment Brain. 2014 May; 137(Pt 5):1550-61. . View in PubMed

The A4 study: stopping AD before symptoms begin? Sci Transl Med. 2014 Mar 19; 6(228):228fs13.. View in PubMed

Design and implementation of a randomized controlled social and mobile weight loss trial for young adults (project SMART) Contemp Clin Trials. 2014 Jan; 37(1):10-8. . View in PubMed

Liposomal bupivacaine as a single-injection peripheral nerve block: a dose-response study Anesth Analg. 2013 Nov; 117(5):1248-56. . View in PubMed

Developing dementia prevention trials: baseline report of the Home-Based Assessment study Alzheimer Dis Assoc Disord. 2013 Oct-Dec; 27(4):356-62. . View in PubMed

Ultrasound-guided root/trunk (interscalene) block for hand and forearm anesthesia Reg Anesth Pain Med. 2013 May-Jun; 38(3):226-32. . View in PubMed

Tracking pathophysiological processes in Alzheimer's disease: an updated hypothetical model of dynamic biomarkers Lancet Neurol. 2013 Feb; 12(2):207-16. . View in PubMed

Continuous femoral nerve blocks: the impact of catheter tip location relative to the femoral nerve (anterior versus posterior) on quadriceps weakness and cutaneous sensory block Anesth Analg. 2012 Sep; 115(3):721-7. . View in PubMed

Modest alcohol consumption is associated with decreased prevalence of steatohepatitis in patients with non-alcoholic fatty liver disease (NAFLD) J Hepatol. 2012 Aug; 57(2):384-91. . View in PubMed

Interact J Med Res. 2012 Apr 04; 1(1):e1. . View in PubMed

Mixed model of repeated measures versus slope models in Alzheimer's disease clinical trials J Nutr Health Aging. 2012 Apr; 16(4):360-4. . View in PubMed

Alzheimer's disease therapeutic trials: EU/US Task Force report on recruitment, retention, and methodology J Nutr Health Aging. 2012 Apr; 16(4):339-45. . View in PubMed

Association of common genetic variants in GPCPD1 with scaling of visual cortical surface area in humans Proc Natl Acad Sci U S A. 2012 Mar 06; 109(10):3985-90. . View in PubMed

Continuous femoral nerve blocks: decreasing local anesthetic concentration to minimize quadriceps femoris weakness Anesthesiology. 2012 Mar; 116(3):665-72. . View in PubMed

Pioglitazone decreases hepatitis C viral load in overweight, treatment naïve, genotype 4 infected-patients: a pilot study PLoS One. 2012; 7(3):e31516. . View in PubMed

Continuous femoral versus posterior lumbar plexus nerve blocks for analgesia after hip arthroplasty: a randomized, controlled study Anesth Analg. 2011 Oct; 113(4):897-903. . View in PubMed

Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block Anesthesiology. 2011 Oct; 115(4):774-81. . View in PubMed

Conditional Akaike information under generalized linear and proportional hazards mixed models Biometrika. 2011 Sep; 98(3):685-700. . View in PubMed

The relative efficiency of time-to-threshold and rate of change in longitudinal data Contemp Clin Trials. 2011 Sep; 32(5):685-93. . View in PubMed

Predictors of response to an attention modification program in generalized social phobia J Consult Clin Psychol. 2011 Aug; 79(4):533-41. . View in PubMed

Pirfenidone for diabetic nephropathy J Am Soc Nephrol. 2011 Jun; 22(6):1144-51. . View in PubMed

Clinical evidence for predominance of delta-5 steroid production in women with polycystic ovary syndrome J Clin Endocrinol Metab. 2011 Apr; 96(4):1106-13. . View in PubMed

Requiring an amyloid-ß1-42 biomarker for prodromal Alzheimer's disease or mild cognitive impairment does not lead to more efficient clinical trials Alzheimers Dement. 2011 Mar; 7(2):245-6; author reply 247-9. . View in PubMed

Report of the task force on designing clinical trials in early (predementia) AD Neurology. 2011 Jan 18; 76(3):280-6. . View in PubMed

The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty Anesth Analg. 2010 Dec; 111(6):1552-4. . View in PubMed

Six-month atrophy in MTL structures is associated with subsequent memory decline in elderly controls Neuroimage. 2010 Dec; 53(4):1310-7. . View in PubMed

Adenovirus 36 and obesity in children and adolescents Pediatrics. 2010 Oct; 126(4):721-6. . View in PubMed

Enrichment through biomarkers in clinical trials of Alzheimer's drugs in patients with mild cognitive impairmentNeurobiol Aging. 2010 Aug; 31(8):1443-511451. e1. . View in PubMed

Pilot study to show the feasibility of a multicenter trial of home-based assessment of people over 75 years old Alzheimer Dis Assoc Disord. 2010 Jul-Sep; 24(3):256-63. . View in PubMed

Clinical Core of the Alzheimer's Disease Neuroimaging Initiative: progress and plans Alzheimers Dement. 2010 May; 6(3):239-46. . View in PubMed

The Alzheimer's Disease Neuroimaging Initiative: Annual change in biomarkers and clinical outcomes Alzheimers Dement. 2010 May; 6(3):257-64. . View in PubMed

Continuous peripheral nerve blocks: is local anesthetic dose the only factor, or do concentration and volume influence infusion effects as well? Anesthesiology. 2010 Feb; 112(2):347-54.. View in PubMed

Alzheimer's Disease Neuroimaging Initiative (ADNI): clinical characterization Neurology. 2010 Jan 19; 74(3):201-9. . View in PubMed

Comparison of inhibin B and estradiol responses to intravenous FSH in women with polycystic ovary syndrome and normal women Hum Reprod. 2010 Jan; 25(1):198-203. . View in PubMed

rTMS for suppressing neuropathic pain: a meta-analysis J Pain. 2009 Dec; 10(12):1205-16. . View in PubMed

Modular psychotherapy for anxiety in older primary care patients Am J Geriatr Psychiatry. 2009 Jun; 17(6):483-92. . View in PubMed

Pediatricians' weight assessment and obesity management practices BMC Pediatr. 2009 Mar 05; 9:19. . View in PubMed

Applications of neuroimaging to disease-modification trials in Alzheimer's disease Behav Neurol. 2009; 21(1):129-36. . View in PubMed

Peripheral blood progenitor cell mobilization with intermediate-dose cyclophosphamide, sequential granulocyte-macrophage-colony-stimulating factor and granulocyte-colony-stimulating factor, and scheduled commencement of leukapheresis in 225 patients undergoing autologous transplantation Transfusion. 2007 Nov; 47(11):2153-60. . View in PubMed

EUS-guided FNA diagnostic yield of malignancy in solid pancreatic masses: a benchmark for quality performance measurement Gastrointest Endosc. 2007 Aug; 66(2):277-82. . View in PubMed

Parental ability to discriminate the weight status of children: results of a survey Pediatrics. 2007 Jul; 120(1):e112-9. . View in PubMed

Anopheles gambiae pilot gene discovery project: identification of mosquito innate immunity genes from expressed sequence tags generated from immune-competent cell lines Proc Natl Acad Sci U S A. 2000 Jun 06; 97(12):6619-24. . View in PubMed

High-dose cisplatin-related peripheral neuropathy Cancer Nurs. 1988 Feb; 11(1):23-32. . View in PubMed

Altered disc compression in children with idiopathic low back pain: an upright magnetic resonance imaging backpack study Spine (Phila Pa 1976). 2014 Feb 01; 39(3):243-8. . View in PubMed

Michael Donohue, PhD is an Associate Professor of Neurology, Associate Director of Biostatistics at the Alzheimer's Therapeutic Research Institute (ATRI), and Co-Lead of the Biostatistics Unit of the Alzheimer's Clinical Trial Consortium (ACTC).

Since obtaining his PhD in Mathematics in 2005, Dr. Donohue has worked on Alzheimer’s clinical trials and observational studies, such as the Alzheimer’s Disease Neuroimaging Initiative (ADNI). His primary area of interest is applying novel statistical methods to data from ADNI to better understand the multivariate course of markers of Alzheimer’s progression, and design innovative clinical trials to prevent or slow the progression of disease. He has studied the risk of cognitive decline associated with elevated brain amyloid in cognitively normal individuals; and helped design the first intervention in asymptomatic Alzheimer’s, the Anti-Amyloid Treatment for Asymptomatic Alzheimer’s (the A4 Study; in collaboration with Eli Lilly), and its primary outcome measure, the Preclinical Alzheimer Cognitive Composite. He has been awarded grants to develop innovative statistical approaches for Alzheimer’s from the National Institute on Aging; the Alzheimer's Association, Michael J. Fox Foundation, and W. Garfield Weston Foundation; and the Clinical and Translation Research Institute of University of California, San Diego
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