Alzheimer s DiseaseNCT07841808
Precuneus Mapping With Sinaptistim® (an Investigational TMS-EEG System) in Mild to Moderate AD Patients
An observational study of Alzheimer s Disease, run by Sinaptica Therapeutics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Alzheimer s Disease
- What is being tested?
- TMS-EEG
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients 65-85 years of age with mild (stage 4) or moderate (stage 5) AD
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Alzheimer s Disease
- Being tested
- TMS-EEG
- Keywords
- Non invasive Brain Stimulation, Transcranial Magnetic Stimulation, Electroencephalography, TMS-EEG, SinaptiStim System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS-EEGDevice
Also called SinaptiStim System
A non-therapeutic transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) assessment to evaluate cortical excitability and network-level brain responses.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TMS-EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with quality EEG recordings
Proportion of enrolled participants with successful completion of the protocol-defined device mapping procedure and acquisition of EEG data meeting predefined quality criteria
Measured: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
Secondary outcomes (4)
Procedural safety and device-related events
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.
Measured: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
Proportion of completed TMS-EEG mapping sessions
Proportion of attempted sessions completed per protocol without major technical failure and with EEG data meeting predefined technical quality criteria.
Measured: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
Critical-task Success Ratings from Site Staff
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.
Measured: Study start through study closeout, approximately 6 months
Screening, eligibility, and enrollment feasibility
Number screened, number eligible, number enrolled, proportion eligible, and reasons for screen failure or non-enrollment.
Measured: Study start through study closeout, approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinaptica Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giacomo Koch, MD, PhD, Study chair, Sinaptica Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841808
- Sponsor's protocol ID
- ST-902
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precuneus Mapping With Sinaptistim® (an Investigational TMS-EEG System) in Mild to Moderate AD Patients
- ClinicalTrials.gov ID
- NCT07841808
- Acronym / sponsor ID
- ST-902
- Conditions
- Alzheimer s Disease
- Keywords
- Non invasive Brain Stimulation, Transcranial Magnetic Stimulation, Electroencephalography, TMS-EEG, SinaptiStim System
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sinaptica Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Mild to Moderate AD Cohort | – | Device: TMS-EEGWe 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients 65-85 years of age with mild (stage 4) or moderate (stage 5) AD
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS-EEGAlso: SinaptiStim SystemA non-therapeutic transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) assessment to evaluate cortical excitability and network-level brain responses. | Device | Observational Mild to Moderate AD Cohort |
Primary outcome
Proportion of participants with quality EEG recordings
Time frame: 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
4 secondary outcomes
Procedural safety and device-related events
Time frame: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
Proportion of completed TMS-EEG mapping sessions
Time frame: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort
Critical-task Success Ratings from Site Staff
Time frame: Study start through study closeout, approximately 6 months
Screening, eligibility, and enrollment feasibility
Time frame: Study start through study closeout, approximately 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giacomo Koch, MD, PhD study chair
Sinaptica Therapeutics, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer s Disease, run by Sinaptica Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kara Detlefsen (720-656-1543, kara@sinapticatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with quality EEG recordings (time frame: Enrollment through study completion, approximately 6 weeks per participant and 6 months for entire study cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.