Deep Repetitive Transcranial Magnetic Stimulation (rTMS) of the Precuneus for Alzheimer Disease (AD) (NCT06597942) | Clinical Trial Compass
RecruitingPhase 1/2
Deep Repetitive Transcranial Magnetic Stimulation (rTMS) of the Precuneus for Alzheimer Disease (AD)
United States54 participantsStarted 2024-10-17
Plain-language summary
The goal of this clinical trial is to learn if using deep repetitive transcranial magnetic stimulation (rTMS) targeting the precuneus is feasible, tolerable, and potentially efficacious for memory in Probable Alzheimer's Dementia. Previous work studying rTMS in Alzheimer's is mixed, but recent work studying rTMS of the precuneus is encouraging for both its short-term and long-term effects. The main questions this study aims to answer are:
* Is deep rTMS of the precuneus feasible and tolerable in Alzheimer's?
* Are there signs of positive brain changes in response to deep rTMS?
* Is deep rTMS potentially efficacious for memory in Alzheimer's? Researchers will compare active stimulation to placebo stimulation while obtaining memory testing and measurements of the brain (imaging, scalp electrode measurements, bloodwork) to see if active treatment works to treat mild-to-moderate probable Alzheimer's Dementia.
Participants will:
* Engage with memory testing, brain scans, and bloodwork during a comprehensive assessment
* Visit the clinic 3 times for 12 consolidated rTMS sessions, followed by 4 once weekly maintenance sessions
* Be offered a full open-label active treatment course after completing their treatment course if they are initially in the placebo group
Who can participate
Age range
60 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 60-100 at the start of the study
* Established diagnosis of Alzheimer's Clinical Syndrome (which is also met through a diagnosis of Alzheimer's Dementia)
* Agreement to participate in study and able to complete informed consent process
* Have a caregiver/study partner who can accompany them to all study visits
* Have a known alternate surrogate decision-maker (in case needed) who can accompany them to the informed consent visit (this person may be the study partner mentioned above)
* Screening MMSE score of 18-26
* Screening GDS score \<6
* Either 1) treated with memory-enhancing medication (cholinesterase inhibitor) 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 for the treatment of depression, anxiety, ADHD, or psychosis for 2 weeks prior to the study
Exclusion Criteria:
* Participant and/or their surrogate are unwilling or unable to provide informed consent
* Currently pregnant or potentially pregnant
* Diagnosis of a dementia or cognitive disorder due to a cause other than Alzheimer's Disease
* Diagnosis of severe Dementia (CDR \> 2.0) 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 neurol…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 1/2, which means it's still in relatively early stages — what does that mean for how much we know about whether deep rTMS targeting the precuneus is safe and effective for Alzheimer's disease?
2The trial is measuring 'completion rate' as its primary outcome, which sounds more like it's tracking whether people can finish the study rather than whether symptoms improve — does that mean we wouldn't necessarily learn much about my loved one's cognitive outcomes from participating?
3The precuneus is a specific brain region being targeted here — can you explain why that area is being studied in Alzheimer's disease and how it differs from other rTMS approaches that might already be available?
4Since this trial is actively recruiting, what would the actual time commitment and visit schedule look like, and is that realistic given where we are right now in managing day-to-day care?
5Before considering this trial, are there standard treatments or other established options we haven't yet tried that might be a better starting point for someone with mild or moderate Alzheimer's disease?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Completion Rate
Timeframe: From enrollment to the end of treatment after 5 weeks