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

21 september 2026 bijgewerkt door: Sinaptica Therapeutics, Inc.

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

30

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar tot 85 jaar (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients 65-85 years of age with mild (stage 4) or moderate (stage 5) AD

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Observational Mild to Moderate AD Cohort

We will enroll up to 30 adults, age 65 to 85, with clinical stage 4 or 5 AD including biological confirmation. Eligible participants will have a MRI and complete a TMS-EEG mapping session.
Apparaat: TMS-EEG

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

Andere namen:
  • SinaptiStim System

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with quality EEG recordings
Tijdsspanne: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort

Proportion of enrolled participants with successful completion of the protocol-defined device mapping procedure and acquisition of EEG data meeting predefined quality criteria
Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Procedural safety and device-related events
Tijdsspanne: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort

Incidence of device-related adverse events, adverse device effects, serious adverse events, and device deficiencies observed during the study visit and immediate post-procedure period.
Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
Proportion of completed TMS-EEG mapping sessions
Tijdsspanne: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort

Proportion of attempted sessions completed per protocol without major technical failure and with EEG data meeting predefined technical quality criteria.
Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
Critical-task Success Ratings from Site Staff
Tijdsspanne: Study start through study closeout, approximately 6 months

Site staff critical-task success and structured ratings of ease of use, workflow fit, and training adequacy. This will be assessed via clinician and technician interviews using sponsor developed questionnaires and interviews.
Study start through study closeout, approximately 6 months
Screening, eligibility, and enrollment feasibility
Tijdsspanne: Study start through study closeout, approximately 6 months.

Number screened, number eligible, number enrolled, proportion eligible, and reasons for screen failure or non-enrollment.
Study start through study closeout, approximately 6 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sinaptica Therapeutics, Inc.

Onderzoekers

  • Studie stoel: Giacomo Koch, MD, PhD, Sinaptica Therapeutics, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 april 2027

Studie voltooiing (Geschat)

1 april 2027

Studieregistratiedata

Eerst ingediend

16 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 september 2026

Eerst geplaatst (Werkelijk)

25 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

21 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • ST-902

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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