42 Participants Needed

Enhanced tDCS for Alzheimer's Disease

CR
Overseen ByCarlos Roncero, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Baycrest
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment transcranial direct current stimulation (tDCS) for Alzheimer's Disease?

Research shows that transcranial direct current stimulation (tDCS) can improve memory and cognitive function in people with Alzheimer's Disease. Studies indicate that tDCS is a safe and promising method for slowing cognitive decline in Alzheimer's patients.12345

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is considered safe and well-tolerated, with no reports of serious adverse effects or irreversible injury in over 33,200 sessions across various human trials, including those involving potentially vulnerable populations like the elderly.12456

How is the treatment tDCS different from other treatments for Alzheimer's disease?

Transcranial direct current stimulation (tDCS) is unique because it is a noninvasive method that uses electrical currents to stimulate the brain, unlike traditional drug treatments. It aims to improve or delay cognitive decline in Alzheimer's patients by directly targeting brain activity, offering a non-drug alternative for managing the condition.12345

What is the purpose of this trial?

There is currently little symptomatic therapy for Alzheimer's Disease (AD) and nothing effective for individuals with Frontotemporal dementia (FTD). However, neuromodulation with transcranial direct current stimulation (tDCS) has the potential to be a clinically effective therapy for both AD and FTD. The challenge now is to specify the parameters and conditions under which tDCS is most effective to transition from the laboratory to clinical medicine. tDCS studies typically report significant group effects despite the variability demonstrated among participants, with some showing clear, meaningful improvement, while others only show statistical improvement or none at all. These variable results may be related to the conventional stimulation intensity level of 2mA. The investigators predict that administering tDCS at 4.0 mA, a more significant number of participants would show a meaningful response, and those who improve at 2mA may improve even more from 4.0mA due to having a larger electric field produced. The investigators aim to test this hypothesis in people with Alzheimer's Disease.

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 4mA StimulationExperimental Treatment1 Intervention
Group II: 2mA StimulationActive Control1 Intervention
Group III: SHAMPlacebo Group1 Intervention

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

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as tDCS for:
  • Investigational for Alzheimer's Disease and Frontotemporal dementia
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as tDCS for:
  • Investigational for Alzheimer's Disease and other neurological conditions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baycrest

Lead Sponsor

Trials
46
Recruited
6,900+

Alzheimer's Society

Collaborator

Trials
10
Recruited
6,300+

Findings from Research

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

References

Transcranial direct current stimulation improves recognition memory in Alzheimer disease. [2022]
Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]
A double-blind randomized clinical trial on the efficacy of cortical direct current stimulation for the treatment of Alzheimer's disease. [2022]
Behavioural and electrophysiological modulations induced by transcranial direct current stimulation in healthy elderly and Alzheimer's disease patients: A pilot study. [2020]
Transcranial Direct Current Stimulation Improves Cognitive Function in Mild to Moderate Alzheimer Disease: A Meta-Analysis. [2020]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
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