NCT06597942 · Phase 1 · RECRUITING
Large-coil Parietal Repetitive Transcranial Magnetic Stimulation (rTMS) for Alzheimer Disease (AD)
This trial tests whether a magnetic stimulation device, placed over the back of the head near a memory-related area called the precuneus, is safe, tolerable, and helpful for memory in people with mild-to-moderate Alzheimer's. Some people get real stimulation, others a sham. It's an early Phase 1 trial, mainly checking feasibility and safety, not proven or approved.
Eligibility criteria
Inclusion Criteria: * Agreement to participate in study and able to complete informed consent process * Have a caregiver or study partner who can accompany them to all study visits * Have a known alternate surrogate decision-maker (in case needed) who can be present for informed consent * Established diagnosis of biomarker-positive (amyloid-PET, plasma or CSF amyloid ratio or phosphorylated tau) mild-moderate (clinical stages 3, 4, and 5) Alzheimer's Disease based on the 2024 Alzheimer's Association Framework * Age 55-100 at the start of the study. * Screening MOCA 12-25 (\< 26, > 11) * Screening GDS score \<6 * Either 1) treated with memory-enhancing medication (cholinesterase inhibitor or other medications or treatments) for at least 2 months, 2) failed trial with no plan to re-trial, or 3) no trial planned during the course of the study for other reasons * No change in use of psychotropic medication (or other treatments) for the treatment of depression, anxiety, ADHD, or psychosis for 2 weeks prior to the study Exclusion Criteria: * Unwilling or unable to provide informed consent as outlined below * Currently pregnant or potentially pregnant * Diagnosis of a dementia or cognitive disorder primarily or exclusively due to a cause other than Alzheimer's Disease * Diagnosis of severe Dementia (CDR > 2.0/ AA clinical stage 6) at the start of the study * History of substance use disorder currently not in sustained remission * Substance misuse within the past 6 months (excluding nicotine or caffeine) * History of stroke, traumatic brain injury with loss of consciousness, or other major neurologic disorder (e.g., epilepsy, Huntington's disease, Parkinson's disease) * History of seizure disorder or family history of seizure disorder in a first-degree relative * Poorly-controlled hypertension, cardiovascular disease, or cerebrovascular disease * History of any other major active medical, neurologic, or psychiatric illness affecting cognition (associated with cognitive impairment) or a participant's ability to safely and meaningfully participate in the study * Non-fluent in English (not native or functionally-native, specified here for cognitive testing purposes) * Contraindication to TMS or MRI including claustrophobia, MRI-incompatible or unknown metal in body (including facial tattoos with uknown or metallic inks), surgery within 60 days, certain implants (excluding dental fillings), or previous abnormal MRI results unrelated to a potential participant's dementia. * For the randomized stage only-has a history of prior TMS treatment (not TMS naïve) * Currently enrolled in an interventional memory-enhancement study * Alteration in cognitive-enhancement medication (or other treatment) dose within the past 2 months or active plans for dose alteration during the course of the study (previously unplanned changes that occur during the study will be examined on a case-by-case basis) * Has started treatment with lecanemab, donanemab, or any other monoclonal antibody for Alzheimer's Disease within the past 6 months OR has a history of treatment complicated by amyloid-related imaging abnormalities (ARIA) * Currently or within the past 2 weeks taking any of the following classes of medication: * Anticholinergic (e.g., tolterodine, benztropine) * Sedating antihistamines (e.g., diphenhydramine) * any drug that has significant anticholinergic or antihistaminic side effects (e.g., tricyclic antidepressant medications, mirtazapine). * Benzodiazepines. While not a strict rule out, this will be decided on a case-by-case basis * Opioid. While not a strict rule out, this will be decided on a case-by-case basis * Antiepileptic agents. While not a strict rule out, this will be decided on a case-by-case basis * Antipsychotic agents. While not a strict rule out, this will be decided on a case-by-case basis
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-09-04