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

Status: Recruiting

Location: See location...

Intervention Type: Device

Study Type: Interventional

Study Phase: Phase 1/Phase 2

SUMMARY

The goal of this clinical trial is to learn if using large-coil (or deep) repetitive transcranial magnetic stimulation (rTMS) targeting the precuneus and surrounding areas is feasible, tolerable, and potentially efficacious for memory in Alzheimer's Disease. 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 Cognitive Impairment (MCI) and mild-to-moderate dementia due to Alzheimer's disease. 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 8 once weekly maintenance visits * Be offered a full open-label active treatment course after completing their treatment course if they are initially in the placebo group

Eligibility

Participation Requirements

Sex: All

Minimum Age: 55

Maximum Age: 100

Healthy Volunteers: f

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• 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

Locations

United States

California

UCLA TMS Clinical and Research Service

RECRUITING

Los Angeles

Contact Information

Primary

Griffin Bohman

TMSResearch@mednet.ucla.edu

(310) 825-4781

Backup

Michael Leuchter, MD, MSc

TMSResearch@mednet.ucla.edu

(310) 206-0995

Time Frame

Start Date: 2024-10-17

Estimated Completion Date: 2029-12

Participants

Target number of participants: 54

Treatments

Experimental: Open-Label Active deep rTMS (First Study Stage)

The first stage of the study will consist of protocol refinement. In this first stage of 5-10 participants, all participants will receive open-label active treatment.~Treatment will consist of 16 sessions of deep rTMS spread over 5 weeks. The induction phase of treatment will be 4 sessions per day for 3 consecutive days (with 60 minutes between sessions), followed by 1 session per week for 4 weeks.~Individual sessions will consist of 1600 pulses of 20Hz rTMS delivered in 40 pulse trains to the precuneus (using MRI structural neuronavigation) at 100% of depth-corrected motor-threshold with a 28 second intertrain interval (roughly 20 minutes per session).

Experimental: Randomized Active deep precuneus rTMS

The second stage of the study will consist of both active and sham treatment groups. Treatment will consist of 28 sessions of deep rTMS spread over 9 weeks. The induction phase of treatment will be 4 sessions per day for 3 consecutive days (with 30-60 minutes between sessions), followed by 1 visit per week (with two sessions per visit separated by 30-60 minutes) for 8 weeks. Individual sessions will consist of 1600 pulses of 20Hz rTMS delivered in 40 pulse trains to the precuneus (using MRI structural neuronavigation) at 100% of depth-corrected motor-threshold with a 20 second intertrain interval (roughly 15-20 minutes per session). The active group will receive this protocol using an active treatment coil delivering real rTMS.

Sham_comparator: Randomized Sham deep precuneus rTMS

The second stage of the study will consist of both active and sham treatment groups. Treatment will consist of 28 sessions of deep rTMS spread over 9 weeks. The induction phase of treatment will be 4 sessions per day for 3 consecutive days (with 30-60 minutes between sessions), followed by 1 visit per week (with two sessions per visit separated by 30-60 minutes) for 8 weeks. Individual sessions will consist of 1600 pulses of 20Hz rTMS delivered in 40 pulse trains to the precuneus (using MRI structural neuronavigation) at 100% of depth-corrected motor-threshold with a 20 second intertrain interval (roughly 15-20 minutes per session). The placebo group will receive this protocol using a sham TMS coil delivering inactive rTMS.~Participants in the sham/placebo group will be offered a full open-label extension treatment course of active rTMS on completion of the randomized phase.

Related Therapeutic Areas

Alzheimer's Disease

Dementia

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