Enhanced tDCS for Alzheimer's Disease

Overseen By Carlos Roncero, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baycrest

Disqualifiers: Stroke, TBI, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a potential new therapy for Alzheimer's Disease (AD) using transcranial direct current stimulation (tDCS), which delivers a small electrical current to the brain. Researchers are testing whether a higher intensity of tDCS at 4mA, compared to the usual 2mA, can more effectively improve symptoms. The trial includes three groups: one receiving 4mA, one with 2mA, and a sham group receiving a placebo treatment. It is suitable for individuals with mild to moderate Alzheimer's who have not experienced strokes or traumatic brain injuries and do not have metal implants. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in Alzheimer's treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for Alzheimer's Disease?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated. A review of studies found that tDCS usually causes mild side effects like tingling and itching, which are temporary and not serious. Other research supports that tDCS is a noninvasive method to stimulate the brain and is considered safe. While mild sensations may occur during treatment, serious side effects are rare. Overall, tDCS has proven to be a safe option for people with conditions like Alzheimer's Disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Alzheimer's, which often involve medications targeting neurotransmitter imbalances, transcranial direct current stimulation (tDCS) offers a non-invasive brain stimulation technique. Researchers are excited about tDCS because it uses low electrical currents to potentially enhance brain function and improve cognitive symptoms associated with Alzheimer's. The treatment's unique delivery method—through electrodes placed on the scalp—makes it distinct from oral medications and may offer fewer side effects. Additionally, the trial's experimental arms explore different stimulation intensities (4mA vs. 2mA), which could provide insights into optimizing the effectiveness of this innovative approach.

What evidence suggests that this trial's treatments could be effective for Alzheimer's Disease?

Research has shown that transcranial direct current stimulation (tDCS) can improve thinking and memory in people with Alzheimer's Disease (AD). Studies have found that tDCS enhances overall thinking skills and memory, especially in tasks like remembering words. In one review, people with AD showed more improvement than those with mild cognitive impairment (MCI) or other types of dementia. Anodal tDCS, which boosts brain activity, proved more effective than other types of stimulation. Multiple tDCS sessions also seem to aid memory improvements. These findings suggest that tDCS could be a promising method for improving symptoms in people with Alzheimer's. This trial will compare different stimulation intensities, including 4mA and 2mA, as well as a sham stimulation, to evaluate their effectiveness in enhancing cognitive function in AD patients. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with mild to moderate Alzheimer's Disease, who score between 18 and 25 on the MoCA test, indicating their cognitive abilities. They must also have a certain score on the Cambridge Naming Task. People with significant heart disease, alcohol or drug abuse history, stroke or traumatic brain injury (TBI), or those with shunts or metal in their body cannot participate.

Inclusion Criteria

Score between 18 and 25 on the MoCA

Score on the Cambridge Naming Task during the pre-assessment

Mild to Moderate AD

Exclusion Criteria

No history of significant heart disease, alcoholism, and drug use

I have never had a stroke or traumatic brain injury.

No shunts or metal in the body

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) at either 2mA or 4mA to test the effectiveness in improving naming ability

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• transcranial direct current stimulation

Trial Overview

The study is testing whether a stronger intensity of transcranial direct current stimulation (tDCS) at 4mA combined with naming training can improve language skills better than the conventional level of 2mA in people living with Alzheimer's Disease.

How Is the Trial Designed?

Group I: 4mA Stimulation Experimental Treatment 1 Intervention

Group II: 2mA Stimulation Active Control 1 Intervention

Group III: SHAM Placebo Group 1 Intervention

transcranial direct current stimulation is already approved in United States, European Union for the following indications:

Approved in United States as tDCS for:

• Investigational for Alzheimer's Disease and Frontotemporal dementia

Approved in European Union as tDCS for:

• Investigational for Alzheimer's Disease and other neurological conditions

Who Is Running the Clinical Trial?

Baycrest

Lead Sponsor

Trials

46

Recruited

6,900+

Alzheimer's Society

Collaborator

Trials

10

Recruited

6,300+

Published Research Related to This Trial

In a study involving 34 Alzheimer's disease patients, both anodal and cathodal transcranial direct current stimulation (tDCS) significantly improved cognitive function as measured by the mini-mental state examination (MMSE) compared to sham stimulation.

tDCS also reduced the P300 latency, a measure associated with cognitive processing, indicating potential benefits in neurorehabilitation for Alzheimer's patients, although it did not affect motor cortex excitability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind randomized clinical trial on the efficacy of cortical direct current stimulation for the treatment of Alzheimer's disease. Khedr, EM., Gamal, NF., El-Fetoh, NA., et al.[2022]

Transcranial direct current stimulation (tDCS) is a safe and noninvasive method that shows promise in treating cognitive decline associated with Alzheimer's disease and mild cognitive impairment.

The review highlights the need for further large-scale clinical trials to better understand the mechanisms of tDCS and improve its application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. Pilloni, G., Charvet, LE., Bikson, M., et al.[2022]

In a study involving 10 patients with Alzheimer's disease, anodal transcranial direct current stimulation (AtDCS) significantly improved recognition memory performance, while cathodal tDCS (CtDCS) led to a decline in performance.

tDCS is shown to be a safe and inexpensive method that could enhance cognitive function in Alzheimer's patients, suggesting potential for further research on its use alongside other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Ferrucci, R., Mameli, F., Guidi, I., et al.[2022]

Transcranial direct current stimulation (tDCS) significantly improved cognitive function in patients with mild to moderate Alzheimer's disease, based on a meta-analysis of seven studies involving 146 patients, with a standardized mean difference of 0.37.

Single sessions of tDCS were effective, particularly when stimulating the temporal cortex, while repeated sessions and lower current densities did not show significant benefits, highlighting the need for careful consideration of treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Improves Cognitive Function in Mild to Moderate Alzheimer Disease: A Meta-Analysis. Cai, M., Guo, Z., Xing, G., et al.[2020]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Anodal transcranial direct current stimulation (tDCS) significantly improved cognitive performance in healthy elderly individuals by increasing neural activity, as evidenced by enhanced P200 and P300 amplitudes during a working memory task.

Cathodal tDCS also showed potential benefits for Alzheimer's disease patients, increasing P200 amplitude and frontal theta activity, suggesting that tDCS can modulate neural function differently based on the individual's cognitive state.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural and electrophysiological modulations induced by transcranial direct current stimulation in healthy elderly and Alzheimer's disease patients: A pilot study. Cespón, J., Rodella, C., Miniussi, C., et al.[2020]

Citations

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This study aims to determine the feasibility and safety of applying tDCS treatment using optimized and personalized tDCS electrode positions in patients with ...

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Overall, the current study showed that rTMS and tDCS can improve memory in AD patients. The rTMS yielded better results when administered in frontal regions, ...

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