Can a Brain-Zapping headset map the Alzheimer's brain?

NCT ID NCT07841808

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are testing an investigational device that combines transcranial magnetic stimulation (TMS) with electroencephalography (EEG) to map brain activity in people with mild to moderate Alzheimer's disease. The study enrolls about 30 participants aged 65 to 85 who have a study partner. Each person attends a screening visit with an MRI and a second visit where the device maps brain responses. The study does not test a treatment; it checks whether the device is safe, works as intended, and collects good-quality brain data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an investigational TMS-EEG brain mapping system called SinaptiStim
What this could lead to
If the device maps brain activity reliably, it could help researchers plan and personalize a later treatment trial that uses brain stimulation for Alzheimer's disease.
What could go wrong
This is a small, early, non-treatment study with no control group, so it cannot show any benefit for Alzheimer's symptoms. The device may fail to record usable brain signals, and TMS can cause scalp discomfort or headaches.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

65 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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