Paul Aisen, MD

Paul Aisen, M.D., has been appointed founding director of USC ATRI. Aisen has been a leading figure in Alzheimer’s disease research for more than two decades, having developed novel methodologies as well as designed and directed many large therapeutic trials. He received his B.A. in biochemistry and molecular biology from Harvard and his medical degree from Columbia. He completed his residency at Case Western Reserve University in Cleveland and Mount Sinai Medical Center in New York, and then fellowship training in rheumatology at New York University. After serving as chief medical resident at Mount Sinai, he began a solo practice in internal medicine and rheumatology in New York. Aisen joined the faculty of Mount Sinai in 1994 and was recruited to Georgetown University in 1999 as a professor of neurology and medicine. That year, he founded the Memory Disorders Program, a clinical and research program for Alzheimer’s disease and related disorders. He continued basic research studies on therapeutic targets and biomarkers and designed and directed multicenter therapeutic trials. He became vice chair of the Department of Neurology at Georgetown in 2004. From 2007 through 2015, he was professor in the Department of Neurosciences at the University of California, San Diego and director of the Alzheimer’s Disease Cooperative Study.

• The Ante-Amyloid Treatment of Alzheimer's disease (A3) Trial and Alzheimer Plasma EXtension (APEX) Study
  NIH · R01AG095009 · Sep 1, 2025 – Aug 31, 2030 · Role: Co-Principal Investigator
• Life?s end Benefits of CannaBidiol and TetrahYdrocannabinol (LiBBY) Open-Label Extension (OLE) Study
  NIH · R01AG095004 · Aug 15, 2025 – Jul 31, 2028 · Role: Co-Principal Investigator
• Randomized Double Blind, Placebo Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease over 18 Months
  NIH · R01AG065248 · Jun 1, 2020 – May 31, 2027 · Role: Co-Principal Investigator
• Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Open-Label Extension Study
  NIH · R01AG063689 · May 15, 2019 – Dec 31, 2024 · Role: Co-Principal Investigator
• Combination anti-amyloid therapy for preclinical Alzheimer's disease
  NIH · R01AG061848 · Sep 30, 2018 – May 31, 2025 · Role: Principal Investigator
• API A4 Alzheimer's Prevention Trial
  NIH · R01AG058468 · Sep 1, 2018 – Nov 30, 2025 · Role: Co-Principal Investigator
• Alzheimer's Clinical Trials Consortium (ACTC)
  NIH · U24AG057437 · Dec 2, 2017 – Aug 31, 2028 · Role: Principal Investigator
• Global Alzheimer's Platform Trial-Ready Cohort for Preclinical/Prodromal Alzheimer's Disease
  NIH · R01AG053798 · May 1, 2017 – Apr 30, 2024 · Role: Principal Investigator
• The A3 Study: Ante-Amyloid Prevention of Alzheimer's disease
  NIH · R01AG054029 · Aug 15, 2016 – Apr 30, 2024 · Role: Co-Principal Investigator
• Long-Term Nicotine Treatment of Mild Cognitive Impairment
  NIH · R01AG047992 · Sep 15, 2015 – May 31, 2022 · Role: Co-Principal Investigator
• A Phase 2 Trial of AAV-NGF Gene Delivery in Alzheimer's Disease
  NIH · R01AG030048 · Aug 1, 2008 – Jun 30, 2015 · Role: Principal Investigator
• Pilot Study of Huperzine A in Alzheimer's Disease
  NIH · R01AG019268 · Sep 30, 2001 – Aug 31, 2007 · Role: Principal Investigator
• Alzheimer's Disease Cooperative Study
  NIH · U19AG010483 · Jul 1, 1997 – Feb 28, 2021 · Role: Co-Principal Investigator
• Alzheimer's Disease Cooperative Study (ADCS)
  NIH · U01AG010483 · Sep 30, 1991 – Nov 30, 2012 · Role: Principal Investigator

• Author Correction: Sleep chart of biological ageing clocks in middle and late life. Nature. 2026 Jul 30.. View in PubMed
• Effects of Omega-3 Fatty Acid Treatment on Risk for Atrial Fibrillation: An Updated Meta-Analysis of 35 Trials including 114 592 Individuals. Circ Arrhythm Electrophysiol. 2026 Jul 28.. View in PubMed
• Prognostic Value of Blood-Based P-Tau217 Levels for Progression to Cognitive Impairment. JAMA. 2026 Jul 14.. View in PubMed
• Relationships between longitudinal retinal amyloid imaging and amyloid PET in the A4 Trial. Alzheimers Dement (Amst). 2026 Jul-Sep; 18(3):e70422.. View in PubMed
• Relationships of CSF biomarkers to cortical atrophy in early-onset Alzheimer’s disease. Alzheimers Dement. 2026 Jul; 22(7):e71479.. View in PubMed
• Recent Cochrane review has serious flaws: A perspective of clinicians and researchers from around the world. Alzheimers Dement. 2026 Jul; 22(7):e71696.. View in PubMed
• Welcome to CTAD25 in San Diego! J Prev Alzheimers Dis. 2026 Jun 10; 13(7):100616. Aisen P . View in PubMed
• Contributions of the Alzheimer’s Disease Neuroimaging Initiative to advancing AD research: a targeted review of recent publications. Alzheimers Dement. 2026 Jun; 22(6):e71566.. View in PubMed
• Improving the clinical trial landscape for patients with atypical variants of Alzheimer’s disease: a call to action. Alzheimers Dement. 2026 Jun; 22(6):e71521.. View in PubMed
• Tau topography subtypes account for clinical heterogeneity and longitudinal trajectories in early-onset Alzheimer’s disease. Brain Commun. 2026; 8(3):fcag176.. View in PubMed
• Sleep chart of biological ageing clocks in middle and late life. Nature. 2026 May 13.. View in PubMed
• Criterion and convergent validity of plasma biomarkers in early-onset Alzheimer’s disease: Initial findings from LEADS. Alzheimers Dement (Amst). 2026 Apr-Jun; 18:e70342.. View in PubMed
• Cognitive dispersion profiles and prediction of cognitive change in early-onset dementias: Results from LEADS. Alzheimers Dement. 2026 May; 22(5):e71492.. View in PubMed
• Remote, unsupervised assessment of cognitive impairment and decline in Alzheimer’s disease using the Cogstate Brief Battery in ADNI-3. Alzheimers Dement. 2026 May; 22(5):e71357.. View in PubMed
• Late-life body mass index and amyloid interaction on cognitive decline in unimpaired older adults. J Prev Alzheimers Dis. 2026 May; 13(5):100543.. View in PubMed
• Divergent patterns of cognitive decline in preclinical Alzheimer’s disease: Implications for secondary prevention trials. Alzheimers Dement. 2026 Apr; 22(4):e71366.. View in PubMed
• Increase in healthcare utilization and Medicare payment with progression of preclinical Alzheimer’s disease. J Prev Alzheimers Dis. 2026 Jun; 13(6):100547.. View in PubMed
• Clinical impact of the Alzheimer’s Disease Neuroimaging Initiative: A review of studies using ADNI data (2023 to June 2025). Alzheimers Dement. 2026 Apr; 22(4):e71353.. View in PubMed
• Evaluating evidence-based recruitment strategies for Alzheimer’s disease and related dementias clinical trial research: A literature review. J Prev Alzheimers Dis. 2026 May; 13(5):100532.. View in PubMed
• Amyloid Imaging and APOE Genotype Disclosure and Short-Term Psychological Distress. JAMA Netw Open. 2026 Mar 02; 9(3):e263845.. View in PubMed
• A path to preventing cognitive impairment due to Alzheimer’s disease: initiatives beginning in the USA. Lancet Neurol. 2026 Mar; 25(3):268-278.. View in PubMed
• The prognostic value of blood-based p-tau217 levels on progression to clinical impairment. medRxiv. 2026 Feb 09.. View in PubMed
• Alzheimer’s clinical research data via R packages: The alzverse. Alzheimers Dement. 2026 Feb; 22(2):e71152.. View in PubMed
• Whole blood gene expression moderates associations between AD biomarkers and cognitive decline in cognitively unimpaired older adults. Alzheimers Dement. 2026 Feb; 22(2):e71225.. View in PubMed
• Relationship between age and severity of cognitive impairment at diagnosis for early-onset and late-onset Alzheimer’s disease: Comparison of LEADS and ADNI. Alzheimers Dement. 2026 Feb; 22(2):e71160.. View in PubMed
• Distinct Tau PET Dynamics in Early vs. Late Age-of-Onset Alzheimer’s disease. medRxiv. 2026 Jan 26.. View in PubMed
• Divergent patterns of cognitive decline in preclinical Alzheimer’s disease: implications for secondary prevention trials. medRxiv. 2026 Jan 21.. View in PubMed
• Prevalence of frailty and its association with cognition in preclinical Alzheimer’s disease: a cross-sectional analysis of baseline data from the A4 study. Age Ageing. 2026 Jan 03; 55(1).. View in PubMed
• Relationship of cholinergic basal forebrain atrophy with the time course of Alzheimer’s disease pathology and cognitive decline in adults with Down syndrome: a longitudinal cohort study. Alzheimers Dement. 2026 Jan; 22(1):e71028.. View in PubMed
• Alzheimer’s disease polygenic risk in early- and late-onset Alzheimer’s disease. Alzheimers Dement. 2026 01; 22(1):e71066.. View in PubMed
• A review of evidence supporting amyloid beta reduction as a surrogate endpoint in Alzheimer’s disease. J Prev Alzheimers Dis. 2026 Feb; 13(2):100458.. View in PubMed
• Effects of Omega-3 Fatty Acid Treatment on Risk for Atrial Fibrillation: An Updated Meta-Analysis of 34 Trials including 114,326 Individuals. medRxiv. 2025 Dec 15.. View in PubMed
• Tablet-based Cognitive Assessment Tool (TabCAT) in a multisite study of early-onset Alzheimer’s disease. Alzheimers Dement. 2025 12; 21(12):e71012.. View in PubMed
• Blood gene expression network expression strongly relates to brain amyloid burden. Alzheimers Dement. 2025 12; 21(12):e70982.. View in PubMed
• Blood-based Transcriptomics Reveal Sex- and Amyloid-Modulated Biology of Plasma pTau217 in Preclinical Alzheimer’s Disease. bioRxiv. 2025 Nov 24.. View in PubMed
• Voiceprints of cognitive impairment: analyzing digital voice for early detection of Alzheimer’s and related dementias. NPJ Dement. 2025; 1(1):35.. View in PubMed
• Response to “Brain Amyloid and Cognitive Decline in Late-Life Depression”. Am J Geriatr Psychiatry. 2026 Feb; 34(2):258-261.. View in PubMed
• MRI-based multi-organ clocks for healthy aging and disease assessment. Nat Med. 2026 Jan; 32(1):82-92.. View in PubMed
• Recruitment and retention in a preclinical AD trial: comparisons between academic and non-academic sites. Alzheimers Res Ther. 2025 10 14; 17(1):222.. View in PubMed
• Independent effects of white matter lesion volume and APOE ɛ4 on ARIA-H in A4 Study. Alzheimers Dement. 2025 10; 21(10):e70751.. View in PubMed
• Concurrent Changes in Plasma Phosphorylated Tau 217, Tau PET, and Cognition in Preclinical Alzheimer Disease. JAMA Neurol. 2025 Oct 01; 82(10):985-993.. View in PubMed
• Multimodal prognostic modeling of individual cognitive trajectories to enhance trial efficiency in preclinical Alzheimer’s disease. Alzheimers Dement. 2025 09; 21(9):e70702.. View in PubMed
• Accelerated Cognitive Decline in Late Life Depression: The Role of Amyloid-β, Cortico-Limbic Volume, and White Matter Hyperintensities. Am J Geriatr Psychiatry. 2026 02; 34(2):183-194.. View in PubMed
• Racial and ethnic differences in plasma p-tau217 ratio biomarker eligibility rates in a preclinical AD trial with lecanemab. Alzheimers Dement (Amst). 2025 Jul-Sep; 17(3):e70164.. View in PubMed
• Sleep chart of biological aging clocks across organs and omics. medRxiv. 2025 Aug 11.. View in PubMed
• Financial Incentives to Increase Diversity of Older Participants in a Memory Concerns Registry: A Randomized Clinical Trial. JAMA Health Forum. 2025 Aug 01; 6(8):e252273.. View in PubMed
• Amyloid-lowering immunotherapies for Alzheimer disease: current status and future directions. Nat Rev Neurol. 2025 09; 21(9):490-498.. View in PubMed
• Multi-organ MRI digitizes biological aging clocks across proteomics, metabolomics, and genetics. medRxiv. 2025 Jul 11.. View in PubMed
• Five years of the Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (IMPACT-AD). Alzheimers Dement. 2025 07; 21(7):e70441.. View in PubMed
• Advancing the science of recruitment for Alzheimer’s clinical trials: Challenges and opportunities. J Prev Alzheimers Dis. 2025 Aug; 12(7):100230.. View in PubMed
• Changes in Daily Functioning in Association With Tau and Amyloid Among Unimpaired Older Adults With and Without Elevated Amyloid. Neurology. 2025 Jun 24; 104(12):e213775.. View in PubMed
• Relationship between use of anti-platelet agents, oral anti-coagulants, and Aβ burden with cerebral microhemorrhages in cognitively asymptomatic adults. Alzheimers Dement. 2025 05; 21(5):e70167.. View in PubMed
• Challenges and opportunities for novel combination therapies in Alzheimer’s disease: a report from the EU/US CTAD Task Force. J Prev Alzheimers Dis. 2025 Jun; 12(6):100163.. View in PubMed
• Donanemab: Appropriate use recommendations. J Prev Alzheimers Dis. 2025 May; 12(5):100150.. View in PubMed
• Amyloid PET in Sporadic Early- Versus Late-Onset Alzheimer’s Disease: Comparison of the LEADS and ADNI Cohorts. Ann Neurol. 2025 08; 98(2):236-248.. View in PubMed
• Dissociable spatial topography of cortical atrophy in early-onset and late-onset Alzheimer’s disease: A head-to-head comparison of the LEADS and ADNI cohorts. Alzheimers Dement. 2025 02; 21(2):e14489.. View in PubMed
• Characterizing and validating 12-month reliable cognitive change in Early-Onset Alzheimer’s Disease for use in clinical trials. J Prev Alzheimers Dis. 2025 Apr; 12(4):100075.. View in PubMed
• Heterogeneous clinical phenotypes of sporadic early-onset Alzheimer’s disease: a neuropsychological data-driven approach. Alzheimers Res Ther. 2025 02 06; 17(1):38.. View in PubMed
• Disclosure of elevated amyloid status is not associated with long-term suicidality in a preclinical AD trial. Alzheimers Dement. 2025 02; 21(2):e14623.. View in PubMed
• Dynamic proportional loss of functional connectivity revealed change of left superior frontal gyrus in subjective cognitive decline: an explanatory study based on Chinese and Western cohorts. Geroscience. 2025 08; 47(4):5619-5634.. View in PubMed
• Artificial intelligence-enabled safety monitoring in Alzheimer’s disease clinical trials. J Prev Alzheimers Dis. 2025 Jan; 12(1):100002.. View in PubMed
• Differences in baseline cognitive performance between participants with early-onset and late-onset Alzheimer’s disease: Comparison of LEADS and ADNI. Alzheimers Dement. 2025 01; 21(1):e14218.. View in PubMed
• Longitudinal cognitive performance of participants with sporadic early onset Alzheimer’s disease from LEADS. Alzheimers Dement. 2025 02; 21(2):e14439.. View in PubMed
• Overview of Alzheimer’s Disease Neuroimaging Initiative and future clinical trials. Alzheimers Dement. 2025 01; 21(1):e14321.. View in PubMed
• Defining benefit: Clinically and biologically meaningful outcomes in the next-generation Alzheimer’s disease clinical care pathway. Alzheimers Dement. 2025 02; 21(2):e14425.. View in PubMed
• The case for regulatory approval of amyloid-lowering immunotherapies in Alzheimer’s disease based on clearcut biomarker evidence. Alzheimers Dement. 2025 01; 21(1):e14342.. View in PubMed
• Cortico-limbic volume abnormalities in late life depression are distinct from β amyloid and white matter pathologies. Mol Psychiatry. 2025 Apr; 30(4):1267-1276.. View in PubMed
• Anxiety in late-life depression: Associations with brain volume, amyloid beta, white matter lesions, cognition, and functional ability. Int Psychogeriatr. 2024 Nov; 36(11):1009-1020.. View in PubMed
• Benefits and risks of FDA-approved amyloid-targeting antibodies for treatment of early Alzheimer’s disease: Navigating clinician-patient engagement. Alzheimers Dement. 2024 11; 20(11):8162-8171.. View in PubMed
• CYP1B1-RMDN2 Alzheimer’s disease endophenotype locus identified for cerebral tau PET. Nat Commun. 2024 09 20; 15(1):8251.. View in PubMed
• Anxiety in late-life depression is associated with poorer performance across multiple cognitive domains. J Int Neuropsychol Soc. 2024 11; 30(9):807-811.. View in PubMed
• The ADNI4 Digital Study: A novel approach to recruitment, screening, and assessment of participants for AD clinical research. Alzheimers Dement. 2024 10; 20(10):7232-7247.. View in PubMed
• The Alzheimer’s Disease Neuroimaging Initiative Clinical Core. Alzheimers Dement. 2024 10; 20(10):7361-7368.. View in PubMed
• A Protocol for the Inclusion of Minoritized Persons in Alzheimer Disease Research From the ADNI3 Diversity Taskforce. JAMA Netw Open. 2024 08 01; 7(8):e2427073.. View in PubMed
• Racial and ethnic differences in plasma biomarker eligibility for a preclinical Alzheimer’s disease trial. Alzheimers Dement. 2024 06; 20(6):3827-3838.. View in PubMed
• Anxiety in late-life depression: Associations with brain volume, amyloid beta, white matter lesions, cognition, and functional ability. Int Psychogeriatr. 2024 11; 36(11):1009-1020.. View in PubMed
• Immediate Reactions to Alzheimer Biomarker Disclosure in Cognitively Unimpaired Individuals in a Global Truncated Randomized Trial. Neurol Clin Pract. 2024 Apr; 14(2):e200265.. View in PubMed
• A Pragmatic, Investigator-Driven Process for Disclosure of Amyloid PET Scan Results to ADNI-4 Research Participants. J Prev Alzheimers Dis. 2024; 11(2):294-302.. View in PubMed
• Editorial: Introduction to the Special Issue on the A4 Study. J Prev Alzheimers Dis. 2024; 11(4):801.. View in PubMed
• Amyloid and Tau Prediction of Cognitive and Functional Decline in Unimpaired Older Individuals: Longitudinal Data from the A4 and LEARN Studies. J Prev Alzheimers Dis. 2024; 11(4):802-813.. View in PubMed
• Characterizing Clinical Progression in Cognitively Unimpaired Older Individuals with Brain Amyloid: Results from the A4 Study. J Prev Alzheimers Dis. 2024; 11(4):814-822.. View in PubMed
• Longitudinal Phospho-tau217 Predicts Amyloid Positron Emission Tomography in Asymptomatic Alzheimer’s Disease. J Prev Alzheimers Dis. 2024; 11(4):823-830.. View in PubMed
• Relationship between Plasma P-Tau217 and Amyloid PET in Racial and Ethnic Underrepresented Groups (RE-URG) Compared with Non RE-URG in LEARN and A4. J Prev Alzheimers Dis. 2024; 11(4):831-837.. View in PubMed
• Longitudinal Trajectories of the Cognitive Function Index in the A4 Study. J Prev Alzheimers Dis. 2024; 11(4):838-845.. View in PubMed
• Change in Digital Cognitive Test Performance between Solanezumab and Placebo Groups in Preclinical Alzheimer’s Disease: Secondary Analyses from the A4 Study. J Prev Alzheimers Dis. 2024; 11(4):846-856.. View in PubMed
• Safety Profile of a Cognitively Unimpaired Older Population with Elevated Cerebral Amyloid in a 4.5-Year Clinical Trial. J Prev Alzheimers Dis. 2024; 11(4):857-868.. View in PubMed
• Greater White Matter Hyperintensity Volume Is Associated with the Number of Microhemorrhages in Preclinical Alzheimer’s Disease. J Prev Alzheimers Dis. 2024; 11(4):869-873.. View in PubMed
• Pre-Randomization Predictors of Study Discontinuation in a Preclinical Alzheimer’s Disease Randomized Controlled Trial. J Prev Alzheimers Dis. 2024; 11(4):874-880.. View in PubMed
• Maximizing the Utility of Alzheimer’s Disease Trial Data: Sharing of Baseline A4 and LEARN Data. J Prev Alzheimers Dis. 2024; 11(4):889-894.. View in PubMed
• Estimating Socio-Economic Status for Alzheimer’s Disease Trials. J Prev Alzheimers Dis. 2024; 11(5):1418-1425.. View in PubMed
• The AlzMatch Pilot Study – Feasibility of Remote Blood Collection of Plasma Biomarkers for Preclinical Alzheimer’s Disease Trials. J Prev Alzheimers Dis. 2024; 11(5):1435-1444.. View in PubMed
• Clinical Meaningfulness in Alzheimer’s Disease Clinical Trials. A Report from the EU-US CTAD Task Force. J Prev Alzheimers Dis. 2024; 11(5):1219-1227.. View in PubMed
• A Statistical Framework for Assessing the Relationship between Biomarkers and Clinical Endpoints in Alzheimer’s Disease. J Prev Alzheimers Dis. 2024; 11(5):1228-1240.. View in PubMed
• Views and Perceptions of Amyloid Imaging in a Preclinical Alzheimer’s Disease Trial. J Prev Alzheimers Dis. 2024; 11(6):1563-1571.. View in PubMed
• Relationship of Hoarding and Depression Symptoms in Older Adults. Am J Geriatr Psychiatry. 2024 04; 32(4):497-508.. View in PubMed
• Plasma Aβ42/Aβ40 and phospho-tau217 concentration ratios increase the accuracy of amyloid PET classification in preclinical Alzheimer’s disease. Alzheimers Dement. 2024 02; 20(2):1214-1224.. View in PubMed
• Eligibility Rates among Racially and Ethnically Diverse US Participants in Phase 2 and Phase 3 Placebo-Controlled, Double-Blind, Randomized Trials of Lecanemab and Elenbecestat in Early Alzheimer Disease. Ann Neurol. 2024 02; 95(2):288-298.. View in PubMed
• The Sporadic Early-onset Alzheimer’s Disease Signature Of Atrophy: Preliminary Findings From The Longitudinal Early-onset Alzheimer’s Disease Study (LEADS) Cohort. Alzheimers Dement. 2023 11; 19.. View in PubMed
• Pathogenic variants in the Longitudinal Early-onset Alzheimer’s Disease Study cohort. Alzheimers Dement. 2023 11; 19.. View in PubMed
• The Alzheimer’s Disease Neuroimaging Initiative in the era of Alzheimer’s disease treatment: A review of ADNI studies from 2021 to 2022. Alzheimers Dement. 2024 01; 20(1):652-694.. View in PubMed

• Thompson, Paul
• Schneider, Lon
• Toga, Arthur
• Rissman, Robert
• Ringman, John
• Raman, Rema