54 Participants Needed

TMS for Alzheimer's Disease

(PROMIS-AD Trial)

DN
ML
CM
Overseen ByCole Mathews
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of California, Los Angeles
Must be taking: Cholinesterase inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a brain stimulation technique called deep repetitive transcranial magnetic stimulation (rTMS) can improve memory in individuals with probable Alzheimer's Dementia. Researchers aim to determine if this treatment is easy to use, well-tolerated, and shows potential for boosting brain function. Participants will receive either active rTMS or a placebo (inactive) version, with an option for real treatment later if they begin in the placebo group. This trial suits individuals with mild-to-moderate Alzheimer's Dementia who are already taking or have tried memory-enhancing medication. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking Alzheimer's research.

Do I need to stop my current medications to join the trial?

You may need to stop certain medications to join the trial. Specifically, you cannot be taking anticholinergic drugs, sedating antihistamines, or medications with significant anticholinergic or antihistaminic side effects. Benzodiazepines, antiepileptic, and antipsychotic agents will be considered on a case-by-case basis.

What prior data suggests that deep rTMS of the precuneus is safe for Alzheimer's patients?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for people with Alzheimer's disease. In various studies, participants have tolerated this treatment well, experiencing few serious side effects. Some mild side effects, such as headaches or scalp discomfort, have occurred but typically do not last long.

Trials targeting a specific area of the brain called the precuneus have demonstrated promising immediate and long-term effects of rTMS. This suggests it might be a helpful approach for Alzheimer's, offering potential benefits while maintaining safety. However, the current trial is in the early stages, so while initial findings are positive, further research is needed to confirm these results.12345

Why are researchers excited about this trial's treatment for Alzheimer's?

Researchers are excited about using deep repetitive transcranial magnetic stimulation (rTMS) for Alzheimer's disease because it offers a novel way to target brain activity. Unlike current treatments that primarily use medications to manage symptoms, rTMS directly stimulates the brain's precuneus region, which is involved in memory and attention. This method uses MRI-guided neuronavigation to deliver precise magnetic pulses, potentially leading to more targeted and effective treatment outcomes. Additionally, the use of a sham comparator group allows researchers to rigorously assess the true effectiveness of this intervention. This approach could pave the way for a more direct and potentially faster-acting therapy for Alzheimer's disease.

What evidence suggests that deep rTMS of the precuneus might be an effective treatment for Alzheimer's?

This trial will evaluate the effects of deep repetitive transcranial magnetic stimulation (rTMS) targeting the precuneus in individuals with Alzheimer's disease. Studies have shown that rTMS can improve memory and thinking skills in people with Alzheimer's. Recent research on the precuneus, a brain region involved in memory, suggests that rTMS targeting this area may have positive effects both in the short and long term. Evidence indicates that rTMS is a safe and potentially effective treatment for Alzheimer's symptoms, with some trials showing improvement in clinical outcomes. These findings offer hope that deep rTMS could be a helpful approach for those with Alzheimer's. Participants in this trial will join either an active deep rTMS group or a sham comparator group to assess the treatment's effectiveness.24567

Who Is on the Research Team?

ML

Michael Leuchter, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for individuals with mild-to-moderate probable Alzheimer's Dementia. Participants will undergo memory testing, brain scans, and bloodwork. They must be able to visit the clinic for multiple rTMS sessions.

Inclusion Criteria

I agree to join the study and can complete the consent process.
I am between 60 and 100 years old.
Have a caregiver/study partner who can accompany them to all study visits
See 6 more

Exclusion Criteria

Currently pregnant or potentially pregnant
I am unable or unwilling to give consent for treatment.
Non-fluent in English (not native or functionally-native)
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 16 rTMS sessions over 5 weeks, including an induction phase with 4 sessions per day for 3 days and a maintenance phase with 1 session per week for 4 weeks.

5 weeks
3 visits for induction, 4 weekly visits for maintenance

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neuropsychological testing and caregiver assessments.

4 weeks

Open-label extension

Participants in the placebo group are offered a full course of active rTMS treatment after completing the randomized phase.

What Are the Treatments Tested in This Trial?

Interventions

  • Deep Repetitive Transcranial Magnetic Stimulation (rTMS) of the Precuneus
Trial Overview The study tests if deep repetitive transcranial magnetic stimulation (rTMS) targeting the precuneus can improve memory in Alzheimer's patients. It compares active stimulation with placebo while monitoring brain changes through various assessments.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Randomized Active deep precuneus rTMSExperimental Treatment1 Intervention
Group II: Open-Label Active deep rTMSExperimental Treatment1 Intervention
Group III: Randomized Sham deep precuneus rTMSPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.
The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation.Kim, WS., Paik, NJ.[2023]
In a study involving 19 participants, both a simple rTMS protocol targeting the left dorsolateral prefrontal cortex (lDLPFC) and a complex protocol involving six brain regions showed similar improvements in cognitive function, behavior, and functionality after 3 weeks of treatment.
The benefits of rTMS were maintained for an additional 4 weeks without further treatment, suggesting that targeting the lDLPFC alone may be sufficient for clinical improvement in Alzheimer's disease symptoms.
Similar clinical improvement and maintenance after rTMS at 5 Hz using a simple vs. complex protocol in Alzheimer's disease.Alcalá-Lozano, R., Morelos-Santana, E., Cortés-Sotres, JF., et al.[2022]
Repetitive transcranial magnetic stimulation (rTMS) showed significant cognitive improvement in Alzheimer's disease patients compared to sham stimulation, as indicated by a reduction in ADAS-cog scores, but did not show improvement in MMSE scores.
rTMS was well tolerated with only a few mild adverse events reported, suggesting it is a safe intervention with potential benefits for cognitive function in Alzheimer's disease.
Repetitive transcranial magnetic stimulation for the treatment of Alzheimer's disease: A systematic review and meta-analysis of randomized controlled trials.Dong, X., Yan, L., Huang, L., et al.[2019]

Citations

Deep Repetitive Transcranial Magnetic Stimulation (rTMS) ...This study is designed to examine whether non-invasive electromagnetic stimulation of a specific brain region can help improve memory in the short-term in ...
Broad repetitive transcranial magnetic stimulation (rTMS) of ...Repetitive transcranial magnetic stimulation (rTMS) can target key DMN hubs, maintain signaling function, and delay or improve clinical outcomes ...
Repetitive transcranial magnetic stimulation for Alzheimer's ...Conclusion: Based on the evidence collected, rTMS appears to be effective in improving cognitive function in AD patients, although the ...
Effectiveness of Personalized Hippocampal ...Repetitive transcranial magnetic stimulation (rTMS) has emerged as a safe potential intervention for AD, with recent clinical trials suggesting ...
Therapeutic potential and mechanisms of repetitive ...This review synthesizes current evidence supporting rTMS as an effective intervention for alleviating clinical symptoms of Alzheimer's disease.
Efficacy and Safety of Transcranial Magnetic Stimulation on ...We aim to analyze the efficacy and safety of TMS on cognition in mild cognitive impairment (MCI), Alzheimer disease (AD), AD-related dementias, and nondementia ...
Broad repetitive transcranial magnetic stimulation (rTMS) of ...Induction-to-maintenance repetitive transcranial magnetic stimulation (rTMS) of the precuneus is a promising treatment for Alzheimer's disease ( ...
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