Can a Brain-Zapping headset map the Alzheimer's brain?
NCT ID NCT07841808
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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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65 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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