Alzheimer DiseaseNCT05478681

Home-based Transcranial Direct Current Stimulation (tDCS) for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)

A study testing active tDCS in people with Alzheimer Disease, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess acceptability, and safety of providing tDCS to ADRD patients with behavioral symptoms and to assess the efficacy of tDCS for ADRD-related symptoms, mainly behavioral symptoms. Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Alzheimer Disease
What is being tested?: active tDCS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 2 sitesUnited States
Study dates: 17 Apr 2023to 26 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

have ADRD and clinically-meaningful behavioral symptoms
have a caregiver willing to participate in the study
can speak and read English
have stable doses of medications for at least one month

Who cannot join

any unstable concurrent medical conditions
history of brain surgery
seizure
intracranial metal implantation
current alcohol/substance use disorder

Trial locations and contacts

2 sites in 1 country.

United States2 sites

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Home-based tDCS for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)

Conditions: Alzheimer Disease
Being tested: active tDCS
Keywords: depression, anxiety, irritability, apathy, psychosis, tDCS
Medical subject headings: Alzheimer Disease, Depression, Anxiety Disorders, Lethargy, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

active tDCSDevice
All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down.

Study groups in NCT05478681
Study group	Role	What they receive
active tDCS	Experimental	All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down. Receives: Device: active tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Measured: week 2
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Measured: week 4
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Measured: week 6
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Measured: week 12
Safety as Assessed by the Side Effects Questionnaire
side effects include itching, burning, headache, fatigue, and dizziness.
Measured: week 2
Safety as Assessed by the Side Effects Questionnaire
side effects include itching, burning, headache, fatigue, and dizziness.
Measured: week 4
Safety as Assessed by the Side Effects Questionnaire
side effects include itching, burning, headache, fatigue, and dizziness.
Measured: week 6

Secondary outcomes (4)

Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale
NPI-Q evaluates 12 discrete neuropsychiatric symptoms considering their severity and the related caregiver distress.
Measured: Baseline, week 2, week 4, week 6, week 12
Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS)
This scale consists of 9 questions each one scored from 0(almost always) to 3(hardly ever), higher scores indicate more apathy
Measured: Baseline, Week 6 and Week 12.
Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia (CSDD)
This questionnaire has 19 questions and each is scored from 0(absent) to 2(severe). A total score greater than 10 indicates probable major depressive episode and a score of greater than 18 indicates definite major depressive episode
Measured: Baseline, Week 6 and Week 12.
Cognition as Evaluated by the Mini-Mental State Examination (MMSE)
Mini-Mental State Examination (MMSE) includes memory, language, praxis and orientation tasks, yielding a global cognition score ranging 0 to 30, with higher scores indicating better performance.
Measured: Baseline, Week 6 and Week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 202326 Feb 2024

First posted28 Jul 2022
Study start17 Apr 2023
Primary completion26 Feb 2024
Study completion26 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05478681
Sponsor's protocol ID: HSC-MS-22-0296
Status last verified: Sep 2025
First submitted: 25 Jul 2022
Last updated: 10 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alzheimer Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Home-based tDCS for Behavioral Symptoms in Alzheimer's Disease and Related Dementias (ADRD)
ClinicalTrials.gov ID: NCT05478681
Acronym / sponsor ID: HSC-MS-22-0296
Conditions: Alzheimer Disease
Keywords: depression, anxiety, irritability, apathy, psychosis, tDCS
Study type: Interventional
Recruitment status: Completed
Enrolment: 3 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: Texas Alzheimer's Research and Care Consortium
Study start: 17 Apr 2023 (actual)
Primary completion: 26 Feb 2024 (actual)
Study completion: 26 Feb 2024 (actual)
First posted: 28 Jul 2022 (actual)
Results: Posted 10 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
active tDCS	Experimental	Device: active tDCSAll participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

have ADRD and clinically-meaningful behavioral symptoms
have a caregiver willing to participate in the study
can speak and read English
have stable doses of medications for at least one month

Key exclusion criteria (5 listed)

any unstable concurrent medical conditions
history of brain surgery
seizure
intracranial metal implantation
current alcohol/substance use disorder

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
active tDCSAll participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down.	Device	active tDCS

Primary outcome

Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
Time frame: week 2
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
Time frame: week 4
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
Time frame: week 6
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire
Time frame: week 12
The tDCS acceptability questionnaire has a total score from 0 to 100, a higher score indicates higher acceptance of the tDCS treatment.
Safety as Assessed by the Side Effects Questionnaire
Time frame: week 2
side effects include itching, burning, headache, fatigue, and dizziness.
Safety as Assessed by the Side Effects Questionnaire
Time frame: week 4
side effects include itching, burning, headache, fatigue, and dizziness.
Safety as Assessed by the Side Effects Questionnaire
Time frame: week 6
side effects include itching, burning, headache, fatigue, and dizziness.

4 secondary outcomes

Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale
Time frame: Baseline, week 2, week 4, week 6, week 12
Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS)
Time frame: Baseline, Week 6 and Week 12.
Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia (CSDD)
Time frame: Baseline, Week 6 and Week 12.
Cognition as Evaluated by the Mini-Mental State Examination (MMSE)
Time frame: Baseline, Week 6 and Week 12.

Results and safety

Results posted to the registry on 10 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active tDCS	3	1

Primary outcome: Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire

Time frame: week 2

Population analysed: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

Primary outcome: Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire

Time frame: week 4

Primary outcome: Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire

Time frame: week 6

Primary outcome: Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire

Time frame: week 12

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Only 3 participants were enrolled in this study. Of the 3 participants only 1 completed the study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active tDCS	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Kendra M Anderson, PhD principal investigator

The University of Texas Health Science Center, Houston

Antonio L Teixeira, MD principal investigator

The University of Texas Health Science Center at San Antonio

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing active tDCS in people with Alzheimer Disease, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. 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?

Yes. Results are posted in the registry (first posted 10 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of the tDCS Treatment as Assessed by the tDCS Acceptability Questionnaire (time frame: week 2). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05478681.

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 10 Oct 2025.