TMS for Alzheimer's Disease
(PROMIS-AD Trial)
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including neuropsychological testing and caregiver assessments.
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor