RecruitingPhase 1Phase 2NCT06597942

Deep Repetitive Transcranial Magnetic Stimulation (rTMS) of the Precuneus for Alzheimer Disease (AD)

Protocol for Maintaining and Improving Mental Status in Alzheimer's Disease (PROMIS-AD): a Pilot Study of Repetitive Transcranial Magnetic Stimulation of the Precuneus for Alzheimer&Amp;Amp;#39;s Disease

Sponsor

University of California, Los Angeles

Enrollment

54 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease Alzheimer&Amp;Amp;#39;s Disease Dementia Alzheimer Type Mild Alzheimer&Amp;Amp;#39;s Disease Moderate Alzheimer&Amp;Amp;#39;s Disease Alzheimer&Amp;#39;s Disease (AD)Alzheimer&Amp;#39;s Dementia

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

Eligibility

Min Age: 60 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brain stimulation technique called deep repetitive TMS (transcranial magnetic stimulation) targeting a region of the brain called the precuneus, to see if it can slow memory decline in people with Alzheimer's disease. **You may be eligible if...** - You are between 60 and 100 years old - You have a confirmed diagnosis of Alzheimer's disease or Alzheimer's dementia - Your memory score (MMSE) is between 18 and 26 (mild to moderate) - You have a caregiver or family member who can accompany you to visits - You are currently on memory medication or have previously tried it **You may NOT be eligible if...** - You have another cause for your memory problems (not Alzheimer's) - Your dementia is severe (CDR score above 2) - You have a history of stroke, traumatic brain injury, epilepsy, Huntington's, or Parkinson's - You have metal implants, a pacemaker, or other MRI contraindications - You have previously received TMS treatment - You are taking anticholinergic, sedating antihistamine, or benzodiazepine medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETMS

rTMS Stimulation Parameters Pulse count: 1600 pulses Frequency: 20Hz Pules per train: 40 pulses Inter-train interval: 28 seconds Intensity: 100% Motor Threshold (depth-corrected from MRI) Target: Precuneus using structural MRI navigation with MNI coordinates

DEVICETranscranial Magnetic Stimulation Sham

Sham coil placed in same location and set with same parameters as active treatment coil. However, this device will not output active treatment and scalp electrodes will mimic the sensation of rTMS for the participant.