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Article History

Received: 1 August 2025

Accepted: 26 January 2026

First Online: 19 February 2026

Declarations

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: The study has been approved by the University of Pittsburgh Institutional Review Board (last renewed on December 16, 2025) and is registered with ClinicalTrials.gov (NCT05138848). The principal investigator submits annual reviews to the IRB for continuing approval. All protocol amendments are submitted to the University of Pittsburgh IRB and approved by the safety officer, as appropriate, prior to implementation. The PiB PET portion of this study was approved under the University of Pittsburgh Radioactive Drug Research Committee (RDRC) mechanism.

: Dr. Gebara has received research support from Janssen. Dr. Gebara and Dr. Wilckens have received compensation from Otsuka for developing and presenting a disease-state webinar.Over the past 3 years, Dr. Buysse (DJB) has served as a paid consultant to Sleep Number (not greater than $5000 per year). Consulting has focused on insomnia, measurement of sleep characteristics, and relationships between sleep and health outcomes. DJB is an author of questionnaires including the Pittsburgh Sleep Quality Index, Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A), Brief Pittsburgh Sleep Quality Index (B-PSQI), Daytime Insomnia Symptoms Scale, Pittsburgh Sleep Diary, Insomnia Symptom Questionnaire, and RU_SATED (copyrights held by University of Pittsburgh). These instruments have been licensed to commercial entities for fees by the University of Pittsburgh. DJB receives a portion of the licensing fees, paid to him by the University of Pittsburgh. He is also co-author of the Consensus Sleep Diary (copyright held by Ryerson University), which is licensed to commercial entities for a fee by Ryerson University. DJB receives a portion of the licensing fees from the University of Pittsburgh through its agreement with Ryerson University. DJB has received grant/contract support from NIH, PCORI, AHRQ, VA, and Sleep Number for research relating to sleep, insomnia, sleep interventions, and questionnaire development.Dr. Karikari (TKK) has consulted for Quanterix Corporation, SpearBio Inc., Neurogen Biomarking LLC., and Alzheon and has served on advisory boards for Siemens Healthineers and Neurogen Biomarking LLC., outside the submitted work. He has received in-kind research support from Janssen Research Laboratories, SpearBio Inc., and Alamar Biosciences, as well as meeting travel support from the Alzheimer’s Association and Neurogen Biomarking LLC., outside the submitted work. TKK has received royalties from Bioventix for the transfer of specific antibodies and assays to third party organizations. He has received honoraria for speaker/grant review engagements from the NIH, UPENN, UW‐Madison, the Cherry Blossom symposium, the HABS-HD/ADNI4 Health Enhancement Scientific Program, Advent Health Translational Research Institute, Brain Health conference, Barcelona‐Pittsburgh conference, the International Neuropsychological Society, the Icahn School of Medicine at Mount Sinai, and the Quebec Center for Drug Discovery, Canada, all outside of the submitted work. TKK is an inventor on several patents and provisional patents regarding biofluid biomarker methods, targets and reagents/compositions, that may generate income for the institution and/or self should they be licensed and/or transferred to another organization. These include WO2020193500A1: Use of a ps396 assay to diagnose tauopathies; US 63/679,361: Methods to Evaluate Early-Stage Pre-Tangle TAU Aggregates and Treatment of Alzheimer’s Disease Patients; US 63/672,952: Method for the Quantification of Plasma Amyloid-Beta Biomarkers in Alzheimer’s Disease; US 63/693,956: Anti-tau Protein Antigen Binding Reagents; and 2450702-2: Detection of oligomeric tau and soluble tau aggregates.