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 range60 Years – 100 Years
SexALL
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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…
What they're measuring
1
Completion Rate
Timeframe: From enrollment to the end of treatment after 5 weeks