Alzheimer DiseaseNCT05509387
Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease
A study testing transcranial direct current stimulation and naming training in people with Alzheimer Disease, run by Baycrest at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- transcranial direct current stimulation and naming training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to Moderate AD
- Score between 18 and 25 on the MoCA
- Score on the Cambridge Naming Task during the pre-assessment
Who cannot join
- No history of stroke or TBI
- No shunts or metal in the body
- No history of significant heart disease, alcoholism and drug use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carlos Roncero, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Baycrest Health Sciences
Toronto, Ontario, M6A 2E1
Carlos Roncero, PhD, 416-785-2500 ext. 2522, troncero@research.baycrest.org
Yashna Kochar, H. BSc, 416-785-2500 ext. 2522, ykochar@research.baycrest.org
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- transcranial direct current stimulation and naming training
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation and naming trainingDevice
Participants will receive mild stimulation or no stimulation along with naming training
| Study group | Role | What they receive |
|---|---|---|
| 4mA Stimulation | Experimental | Not described Receives: Device: transcranial direct current stimulation and naming training |
| 2mA Stimulation | Active comparator | Not described Receives: Device: transcranial direct current stimulation and naming training |
| SHAM | Sham comparator | Not described Receives: Device: transcranial direct current stimulation and naming training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Society
- Responsible party
- Principal investigator, Tyler Roncero, Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509387
- Sponsor's protocol ID
- #22-19
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2022
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05509387
- Acronym / sponsor ID
- #22-19
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Collaborators
- Alzheimer's Society
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4mA Stimulation | Experimental | Device: transcranial direct current stimulation and naming training |
| 2mA Stimulation | Active comparator | Device: transcranial direct current stimulation and naming training |
| SHAM | Sham comparator | Device: transcranial direct current stimulation and naming training |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to Moderate AD
- Score between 18 and 25 on the MoCA
- Score on the Cambridge Naming Task during the pre-assessment
Key exclusion criteria (3 listed)
- No history of stroke or TBI
- No shunts or metal in the body
- No history of significant heart disease, alcoholism and drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulation and naming trainingParticipants will receive mild stimulation or no stimulation along with naming training | Device | 2mA Stimulation, 4mA Stimulation, SHAM |
Primary outcome
Naming Training
Time frame: 3 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Roncero, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation and naming training in people with Alzheimer Disease, run by Baycrest at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Roncero, PhD (troncero@research.baycrest.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Naming Training (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.