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NCT07841808

Precuneus Mapping With Sinaptistim® (an Investigational TMS-EEG System) in Mild to Moderate AD Patients

Sponsor: Sinaptica Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

65 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-10

Completion Date

2027-04

Last Updated

2026-09-25

Healthy Volunteers

Conditions

Alzheimer s Disease

Interventions

DEVICE

TMS-EEG

A non-therapeutic transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) assessment to evaluate cortical excitability and network-level brain responses.

Inclusion Criteria: * Must have a reliable study partner with at least 10 hours per week of direct or indirect contact. The study partner must be willing and able to provide informed consent, participate in the study visits and provide information for protocol-required assessments. * Participant and study partner must each provide signed informed consent before initiation of any study-specific assessments or procedures. * 65 to 85 years of age * Stable non-AD medications for at least 4 weeks before signing informed consent * If treated with a cholinesterase inhibitor for symptoms related to Alzheimer's disease, the dose must be stable for at least 12 weeks before signing informed consent. * Documented cognitive impairment with decline in memory for more than 6 months before signing informed consent * Clinical stage 4 or 5 Alzheimer's disease with biological confirmation * MMSE score 18 to 26 inclusive at Screening * Screening CDR Global Score of 0.5 to 2.0, with CDR Memory Box score of at least 0.5 plus one additional domain Box score of at least 0.5 Exclusion Criteria: * Any contraindication to MRI required by the protocol, including non-compatible implanted metal or electronic devices, ferromagnetic intracranial or other unsafe metallic implants, severe claustrophobia not manageable per site practice, or any other condition making MRI unsafe or not feasible. * Current participation in another interventional clinical study, or receipt of any investigational drug, biologic, or device within 3 months before signing informed consent. * Prior treatment with an anti-amyloid monoclonal antibody for Alzheimer's disease that is: * Less than 6 months of continuous treatment immediately before informed consent, or * Not at a stable label-recommended maintenance dose/maximally tolerated dose, or * Interrupted for \> 8 consecutive weeks during that 6-month period, or * Associated at any time prior to informed consent with ARIA-E or ARIA-H (including microhemorrhage, superficial siderosis, or macro hemorrhage) that resulted in temporary or permanent interruption, delay, or discontinuation of anti-amyloid monoclonal antibody treatment. * Current use of, or plan to initiate any brain stimulation therapy before completion of this study. * Current use of medications that may alter cortical excitability, seizure threshold, sedation, or interpretation of treatment response. * Clinical history, laboratory findings, or neuroimaging findings consistent with any significant clinical neurodegenerative or neurologic disorder, cerebrovascular disease, structural intracranial abnormality or central nervous system lesion that may increase risk with TMS or confound study assessments. * History of seizure disorder, epilepsy, unprovoked seizure, or any seizure considered by the investigator to indicate increased risk with TMS. * Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study, including inability to comply with study requirements.