ClinicalTrials.gg
CompletedNCT05478681Updated Oct 10, 2025Results posted

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

An interventional study of active tDCS in Alzheimer Disease, sponsored by The University of Texas Health Science Center, Houston. Completed at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-10-10.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,939 studies in Alzheimer Disease with a site in United States — 345 open to participants now, 445 under way, 40 of them phase 3. Alzheimer Disease · United States.

Enrollment
1,553rd of 1,608
3 · median 73
Started
2023
with 114 others
No phase
608 of 1,939
130 open now
Registered
1,480th of 1,939
by date

Among the 1,939 studies in Alzheimer Disease with a site in United States, this one is the 1,553rd largest by enrollment of the 1,608 interventional ones that give a count, is one of 115 that started in 2023, is one of 608 with no phase, and was the 1,480th registered.

Alzheimer Disease

3,967 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.

Browse Alzheimer Disease studies →

Open to participants now

345 of the 1,939 studies in Alzheimer Disease with a site in United States are open now. Recruiting first, the newest first:

340 more — sign in →

All 345 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Alzheimer Disease

Keywords

  • depression
  • anxiety
  • irritability
  • apathy
  • psychosis
  • tDCS
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • any unstable concurrent medical conditions
  • history of brain surgery
  • seizure
  • intracranial metal implantation
  • current alcohol/substance use disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    active tDCS

    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.

    Device: active tDCS

Interventions

  • Deviceactive tDCS

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: week 2

  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.

    Time frame: week 4

  3. 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.

    Time frame: week 6

  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.

    Time frame: week 12

  5. Safety as Assessed by the Side Effects Questionnaire

    side effects include itching, burning, headache, fatigue, and dizziness.

    Time frame: week 2

  6. Safety as Assessed by the Side Effects Questionnaire

    side effects include itching, burning, headache, fatigue, and dizziness.

    Time frame: week 4

  7. Safety as Assessed by the Side Effects Questionnaire

    side effects include itching, burning, headache, fatigue, and dizziness.

    Time frame: week 6

Secondary outcomes

  1. 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.

    Time frame: Baseline, week 2, week 4, week 6, week 12

  2. 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

    Time frame: Baseline, Week 6 and Week 12.

  3. 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

    Time frame: Baseline, Week 6 and Week 12.

  4. 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.

    Time frame: Baseline, Week 6 and Week 12.

07

Results

Posted Oct 10, 2025

Participant flow

Participant flow — Overall Study
MilestoneActive tDCS
Started3
Completed1
Not completed2

Outcome measures

PrimaryAcceptability 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.

Time frame:
week 2

No measurements were reported for this outcome.

PrimaryAcceptability 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.

Time frame:
week 4

No measurements were reported for this outcome.

PrimaryAcceptability 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.

Time frame:
week 6

No measurements were reported for this outcome.

PrimaryAcceptability 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.

Time frame:
week 12

No measurements were reported for this outcome.

PrimarySafety as Assessed by the Side Effects Questionnaire

side effects include itching, burning, headache, fatigue, and dizziness.

Time frame:
week 2

No measurements were reported for this outcome.

PrimarySafety as Assessed by the Side Effects Questionnaire

side effects include itching, burning, headache, fatigue, and dizziness.

Time frame:
week 4

No measurements were reported for this outcome.

PrimarySafety as Assessed by the Side Effects Questionnaire

side effects include itching, burning, headache, fatigue, and dizziness.

Time frame:
week 6

No measurements were reported for this outcome.

SecondaryDementia-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.

Time frame:
Baseline, week 2, week 4, week 6, week 12

No measurements were reported for this outcome.

SecondaryApathy 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

Time frame:
Baseline, Week 6 and Week 12.

No measurements were reported for this outcome.

SecondaryDepressive 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

Time frame:
Baseline, Week 6 and Week 12.

No measurements were reported for this outcome.

SecondaryCognition 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.

Time frame:
Baseline, Week 6 and Week 12.

No measurements were reported for this outcome.

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Active tDCS———

Baseline characteristics

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.

Age, Categorical
Age, CategoricalActive tDCS
<=18 years—
Between 18 and 65 years—
>=65 years—
Sex: Female, Male
Sex: Female, MaleActive tDCS
Female—
Male—
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)Active tDCS
Hispanic or Latino—
Not Hispanic or Latino—
Unknown or Not Reported—
Race (NIH/OMB)
Race (NIH/OMB)Active tDCS
American Indian or Alaska Native—
Asian—
Native Hawaiian or Other Pacific Islander—
Black or African American—
White—
More than one race—
Unknown or Not Reported—
Region of Enrollment
Region of Enrollment(participants)Active tDCS
08

Study locations

2 sites
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
  • The University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2023 to primary completion in Feb 2024, 10 months.

Results were first posted in Oct 2025, 1 year 7 months after primary completion.

Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's 10 months is below that.

Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2022
First posted
Jul 28, 2022
StartActual
Apr 17, 2023
Primary completionActual
Feb 26, 2024
CompletionActual
Feb 26, 2024
Results first posted
Oct 10, 2025
Last update
Oct 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05478681
Collaborators
Texas Alzheimer's Research and Care Consortium
Responsible party
Kendra Anderson (Assistant Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jul 28, 2022
Start date
Apr 17, 2023
Primary completion
Feb 26, 2024
Completion
Feb 26, 2024
Results posted
Oct 10, 2025
Last update
Oct 10, 2025

Study contacts

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

Oversight

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

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