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Life sciences · Observational Study
ClinicalTrials.gov · September 25, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07841808). This is a study registration, not published results. Lead sponsor: Sinaptica Therapeutics, Inc.. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Alzheimer s Disease. Interventions: DEVICE: TMS-EEG. Primary outcome measures: Proportion of participants with quality EEG recordings , Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort. Brief summary: Transcranial magnetic stimulation (TMS), electroencephalography (EEG), and combined TMS-EEG approaches have been used in human research to characterize cortical excitability and network-level neurophysiologic responses. The SinaptiStim System is an investigational integrated TMS-EEG platform designed to synchronize TMS delivery, EEG acquisition, and is intended to support standardized characterization of neurophysiologic responses and individualized mapping of stimulation parameters relevant to later therapeutic use. The rationale for this early single-site, non-treatment study is to obtain initial clinical evidence that the investigational device can be used safely and as intended in participants with mild to moderate Alzheimer's disease (AD), can acquire EEG data of sufficient quality for the planned application, and can be implemented operationally at the clinical site with appropriate training and usability prior to launch of a larger treatment trial. The study involves two visits, a screening visit with magnetic resonance imaging (MRI) followed by a TMS-EEG mapping visit. Participants who complete this study successfully may be invited to provide informed consent for screening and potential enrollment in a future treatment protocol. This study does not include randomization or a sham control group or therapeutic treatment.