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

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

Conditions

• Alzheimer&Amp;Amp;#39;s Disease
• Alzheimer 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

Interventions

DEVICE

TMS

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

DEVICE

Transcranial 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.

Sponsors & Collaborators

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Michael Leuchter, MD · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-17

Primary Completion

2026-10-31

Completion

2026-10-31

FDA Device

Yes

Countries

• United States

Study Locations