CClinicalTrials.gg
RecruitingNCT05509387Updated Aug 13, 2024

Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease

An interventional study of transcranial direct current stimulation and naming training in Alzheimer Disease, sponsored by Baycrest. Recruiting at 1 site in Canada. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Baycrest · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Sep 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 42 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Baycrest is the lead sponsor of 33 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Mild to Moderate AD
  • Score between 18 and 25 on the MoCA
  • Score on the Cambridge Naming Task during the pre-assessment

Exclusion criteria

Exclusion Criteria:

  • No history of stroke or TBI
  • No shunts or metal in the body
  • No history of significant heart disease, alcoholism and drug use
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    4mA Stimulation

    Device: transcranial direct current stimulation and naming training

  • Active comparator
    2mA Stimulation

    Device: transcranial direct current stimulation and naming training

  • Sham comparator
    SHAM

    Device: transcranial direct current stimulation and naming training

Interventions

  • Devicetranscranial direct current stimulation and naming training

    Participants will receive mild stimulation or no stimulation along with naming training

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What researchers measure

Primary outcomes

  1. Naming Training

    The primary outcome measure will be change on the naming lists administered, both a trained version and an untrained version. This change will be measured in terms of the number of images correctly named post-training compared to baseline

    Time frame: 3 months

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Study locations

1 of 1 sites recruiting
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References and documents

Study documents

  • Study protocol · Aug 9, 2022
  • Informed consent form · Aug 9, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05509387
Lead sponsor
Baycrest
Collaborators
Alzheimer's Society
Responsible party
Tyler Roncero (Scientific Associate, Baycrest) — Principal investigator
First posted
Aug 22, 2022
Start date
Sep 1, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 13, 2024

Study contacts

Carlos Roncero, PhD
Contact
troncero@research.baycrest.org

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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