40 Participants NeededMy employer runs this trial

Brain Stimulation for Alzheimer's Dementia

RM
SY
Overseen ByShayla Yonce, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) can improve short-term memory in people with early Alzheimer's disease. Researchers aim to determine if this method, which involves applying magnetic pulses to the brain, enhances memory function and affects brain activity. Participants will receive either real rTMS or a sham (fake) treatment over several weeks. The study seeks individuals with early Alzheimer's who have been diagnosed with mild cognitive impairment or mild dementia due to Alzheimer's. The trial aims to discover new ways to support memory in those affected by this condition. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new memory support methods for Alzheimer's.

What prior data suggests that this brain stimulation technique is safe for Alzheimer's patients?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for people with Alzheimer's disease. Studies indicate that rTMS does not cause serious side effects. The most common issues include mild headaches and scalp discomfort during treatment, which usually resolve quickly.

In over 100,000 cases, rTMS has proven safe, with no serious adverse effects reported. Some studies even suggest that rTMS can enhance cognitive functions, such as memory, in individuals with mild to moderate Alzheimer's disease.

Overall, rTMS appears to be a safe option for those considering participation in a clinical trial.12345

Why are researchers excited about this trial?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it offers a non-invasive approach to treating Alzheimer's dementia by using magnetic fields to stimulate nerve cells in the brain. Unlike current treatments for Alzheimer's, which often involve medications like donepezil or memantine that primarily target symptoms, rTMS focuses on enhancing brain activity and potentially altering disease progression. Researchers are excited about this treatment because it might improve cognitive function with fewer side effects than traditional drug therapies and could be a game-changer in how we approach neurodegenerative diseases.

What evidence suggests that repetitive transcranial magnetic stimulation (rTMS) is effective for improving memory in early Alzheimer's disease?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) might improve memory in people with Alzheimer's disease. Several studies have found that rTMS can enhance cognitive function, including thinking and memory skills. For instance, a review of multiple studies found that rTMS improved overall thinking abilities and daily living skills in patients with mild to moderate Alzheimer's. Another study found that rTMS could maintain or even boost thinking skills in those with early to moderate Alzheimer's. These findings suggest that rTMS might positively affect memory and thinking in people with Alzheimer's. Participants in this trial will receive either active rTMS or a sham treatment to further evaluate its effects.26789

Are You a Good Fit for This Trial?

This trial is for people with early Alzheimer's disease or mild memory problems. Participants should have mild cognitive impairment or early dementia and be able to undergo MRI scans. Those with certain medical conditions, metal implants, or other factors that make brain stimulation unsafe cannot join.

Inclusion Criteria

I have been diagnosed with early Alzheimer's disease or mild cognitive impairment.
Evidence of cognitive impairment, characterized by a MMSE score between 20 and 28 and/or a CDR-Sum of Boxes score between 0.5 and 8, consistent with contemporary definitions used in early AD in clinical trials
I have a positive blood test for Alzheimer's disease biomarkers.

Exclusion Criteria

Evidence of other neurological, psychiatric, or systemic conditions that could cause cognitive and functional impairments, including substantial concomitant cerebrovascular disease, alcoholism, certain medications that could substantially affect cognition, untreated major depressive disorder, and heart, renal or hepatic failure
I do not have seizures or metal in my head that would prevent rTMS treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive 20 sessions of rTMS over 4 weeks, with sessions lasting 20-30 minutes each

4 weeks
20 visits (in-person)

Post-Treatment Assessment

Participants undergo repeat fMRI imaging and cognitive assessments immediately after treatment

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness at 3- and 6-month follow-up visits

6 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • repetitive transcranial magnetic stimulation (rTMS)

Trial Overview

The study tests whether repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain procedure, can improve short-term memory in early Alzheimer's. Participants are randomly assigned to receive either real rTMS or a sham (inactive) version over 4 weeks.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: repetitive transcranial magnetic stimulation (rTMS)Active Control1 Intervention
Group II: shamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Chi-Ying (Roy) Lin

Lead Sponsor

Texas Alzheimer's Research and Care Consortium

Collaborator

Trials
4
Recruited
10,100+

Citations

Repetitive transcranial magnetic stimulation for the treatment ...

Several studies have demonstrated that repetitive transcranial magnetic stimulation (rTMS) may have a beneficial effect in Alzheimer's disease ( ...

Efficacy and Durability of Repetitive Transcranial Magnetic ...

This meta-analysis evaluated the efficacy and durability of rTMS in patients with mild to moderate AD and explored potential moderating factors.

Effects and safety of repetitive transcranial magnetic ...

Fourteen studies contributing 15 datasets were included. Compared with sham or control interventions, rTMS was associated with higher post-intervention scores ...

Study Details | NCT02908815 | Investigating the Effect of ...

The main objective of this study is to investigate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) treatment on patients with probable early ...

Short and Long-term Effects of rTMS Treatment on Alzheimer's ...

It appears that rTMS can be an effective tool for improving the cognitive abilities of patients with early to moderate stages of AD. However, ...

A randomized placebo-controlled double-blind clinical trial

The overall results show significant cognitive improvement after treatment up to two months post-treatment with either sham or active coils.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30735817/

The role of repetitive transcranial magnetic stimulation ...

rTMS can significantly improve cognitive ability in patients with mild to moderate AD. Stimulation of multiple sites and long-term treatment ...

Transcranial Magnetic Stimulation in Alzheimer's Disease

Although small clinical trials in AD have reported positive effects on cognitive outcome measures, significant knowledge gaps remain, and little ...

Effects of Repetitive Transcranial Magnetic Stimulation in ...

This study shows that rTMS can improve cognitive function in patients with MCI, especially when applied at high frequency, multi-site, and for ...