Alzheimer DiseaseNCT06801639
Advancing Alzheimer's Care: Home-based tDCS for Affective Symptoms
A study testing Transcranial direct current stimulation (tDCS) in people with Alzheimer Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Participants will be asked to participate in this research study of a device that creates transcranial direct current stimulation (tDCS). The researchers hope to learn if 30 minute sessions of transcranial direct current stimulation (tDCS) improve such a mood or feelings in people with Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to Dec 2028
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Individuals who are 60 years or older.
- Diagnosis of possible or probable AD according to the National Institute of Aging - Alzheimer's Association diagnostic criteria; individuals with mild cognitive impairment (MCI) due to AD, as defined by these criteria, are eligible if biomarker evidence supports the underlying AD pathology (e.g., amyloid or tau positivity in CSF or PET imaging).
- In the determination of the PI in consultation with the delegated physician(s) patient's signs/symptoms are consistent with: a Clinical Dementia Rating (CDR) of 0.5 (MCI) with biomarker evidence of AD; or a Clinical Dementia Rating score of 1-2 (mild to moderate dementia).
- Clinically meaningful AS of ADRD is defined by the presence of any affective symptom (i.e., depression, elation, anxiety, irritability, and apathy) and a total severity score on the NPI-Q ≥10.
- Have an eligible caregiver willing to be present during stimulation sessions and answer questionnaires (see criteria below).
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- Can speak and read in English.
- Stable doses of medications for at least one month.
- Access to a reliable broadband internet connection.
- Caregiver
- An adult who serves as an unpaid caregiver for an individual enrolled in the study as interpreted by the PI or delegate physician.
- Adequate cognitive capacity to provide verbal consent to participate in the caregiver arm of the study.
- Adequate reading, writing, hearing and verbal capacity to provide collateral information about the study participant, answer questions related to their health and care, and assist in tDCS sessions,
Who cannot join
- Unstable medical conditions (e.g. unstable angina, uncontrolled diabetes and hypertension, advanced cancer, etc.) that, in the opinion of the PI in consultation with delegated physician(s) would contraindicate study participation for safety or data quality reasons.
- Medical history of serious psychiatric disorders (i.e. bipolar disorder, schizophrenia, manic depression etc.).
- History of epilepsy.
- Metallic objects in the brain, skull, or otherwise placed where it could interfere with DCS.
- Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening;
- Unwillingness to undergo MRI at baseline and during the Week 2 conversion period for reasons other than a confirmed medical contraindication such as having a pacemaker or other implanted medal making MRI unsafe.
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- Being an active participant in other therapeutic clinical trial.
- Caregiver
- 1. Any individual who does not meet all the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Thiago Macedo e Cordeiro, MD, MSc, 210-450-8418, macedoecorde@uthscsa.edu
Antonio L Teixeira, MD, PhD, 210-450-8636, teixeiraa@uthscsa.edu
About this study
Official title: Advancing Alzheimer's Care: Home-based tDCS (Transcranial Direct Current Stimulator) for Affective Symptoms
Participants will be asked to participate in this research study of a device that creates transcranial direct current stimulation (tDCS).
The researchers hope to learn if 30 minute sessions of transcranial direct current stimulation (tDCS) improve such a mood or feelings in people with Alzheimer's Disease.
Read more
This study involves the use of an investigational device called a tDC stimulator. "Investigational" means that the device has not yet been approved by the U.S. Food \& Drug Administration (FDA) for treating Alzheimer's Disease.
This study will help find out what effects, good and/or bad, this has. The safety of this device in humans has been tested in prior research studies; however, some side effects may not yet be known.
Read the detailed description
Three in-person visits will occur: (1) on the week prior to the first day of stimulation visit patients will undergo brain MRI scan to collect T1, T2, DWI and resting state functional MRI (rs-fMRI), and functional Near-Infrared Spectroscopy/Electroencephalography (fNIRS/EEG) imaging. In this visit, patients and caregivers will be taught how to operate the tDCS device and will receive a unit to take home; (2) on the day after completing the first treatment period, patients will undergo a second MRI scan with the same sequences and fNIRS/EEG imaging; (3) on the day after completing the second treatment period, at the end of week 5, patients will return the tDCS device to the study team and perform a last fNIRS/EEG imaging.
At in-person visits and during treatment periods patients will be asked questions regarding tolerability and acceptability, including monitoring for side effects, as well as completing questionnaires that assess cognition and NPS. All sessions will be remotely supervised via video conference platform.
- Conditions
- Alzheimer Disease
- Being tested
- Transcranial direct current stimulation (tDCS), Sham tDCS
- Keywords
- Transcranial direct current stimulation, TDCS, Home-based, Cognitive symptoms
- Medical subject headings
- Alzheimer Disease, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
Also called tDCS
The active-tDCS treatment will consist of a constant 2mA current applied during daily 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. The anode electrode will be placed over the left dorsolateral prefrontal cortex (DLPFC) and the cathode electrode over the right DLPFC.
Sham tDCSDevice
Also called Control
Sham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature.
| Study group | Role | What they receive |
|---|---|---|
| Active TDCS treatment | Experimental | The active-tDCS treatment will consist of a constant 2mA current applied during 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. Receives: Device: Transcranial direct current stimulation (tDCS) |
| Sham TDCS treatment | Sham comparator | Sham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric Inventory Questionnaire (NPI-Q) severity score
A 12 item questionnaire that measures a broad range of psychiatric symptoms. Each individual item is scored from 0 to 3.
Total scores range from 0 to 36, with higher scores indicating more severe symptoms.
Measured: Baseline to Day 35
Brief Dimensional Apathy Scale (bDAS)
A 9 item scale completed by caregivers about the participant. Each item is scored from 0 to 3.
Total scores range from 0-27 with a higher score indicating more severe apathy.
Measured: Baseline to Day 35
Caregiver version of the Irritability Questionnaire (IrQ) How often
A 10 item questionnaire, and each item is scored from 0 to 3. Total scores can range from 0-30 with a higher score indicating more frequent symptoms.
Measured: Baseline to Day 35
Caregiver version of the Irritability Questionnaire (IrQ) How much
A 10 item questionnaire, and each item is scored from 0 to 3. Total scores can range from 0-30 with a higher score indicating more severe symptoms.
Measured: Baseline to Day 35
Cornell Scale for Depression in Dementia (CSDD)
A 19 item scale which is scored as follows:
a - Unable to evaluate the sign or symptom 0 - Absent
- - Mild or intermittent
- - Severe Total scores range from 0-38 with a higher score indicating greater depression.
Measured: Baseline to Day 35
Generalized Anxiety Disorder-7 Scale (GAD-7)
A 7 item scale scored as follows:
0 - Not at all
- - Several days
- - More than half the days
- - Nearly every day Total scores range from 0-21 with a higher score indicating greater anxiety.
Measured: Baseline to Day 35
Montreal Cognitive Assessment (MoCA)
A battery of cognitive assessment tasks. Total possible score that can be achieved is between 0-30. A higher score indicating better cognition.
Measured: Baseline to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start15 Jul 2025
- Primary completionFeb 2028 (estimated)
- Study completionDec 2028 (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.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Model description
- This is a randomized double-blind cross-over clinical trial to investigate the effects of transcranial direct current stimulation (tDCS) over affective symptoms (AS) of patients with Alzheimer's disease (AD). The study will also investigate underlying neurobiological mechanisms of tDCS in AD with functional and structural neuroimaging techniques.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Sponsor
- Investigators
- Thiago Macedo e Cordeiro, MD, MSc, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801639
- Sponsor's protocol ID
- STUDY00001032
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data collected for this study will be analyzed and stored at the Glenn Bigs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio. After the study is completed, the de-identified, archived data will be transmitted to and stored at the Glenn Bigs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio, for use by other researchers including those outside of the study. Permission to transmit data to the Glenn Biggs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio will be included in the informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Alzheimer's Care: Home-based tDCS (Transcranial Direct Current Stimulator) for Affective Symptoms
- ClinicalTrials.gov ID
- NCT06801639
- Acronym / sponsor ID
- STUDY00001032
- Conditions
- Alzheimer Disease
- Keywords
- Transcranial direct current stimulation, TDCS, Home-based, Cognitive symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Jan 2025 (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.
Participants will be asked to participate in this research study of a device that creates transcranial direct current stimulation (tDCS).
The researchers hope to learn if 30 minute sessions of transcranial direct current stimulation (tDCS) improve such a mood or feelings in people with Alzheimer's Disease.
This study involves the use of an investigational device called a tDC stimulator. "Investigational" means that the device has not yet been approved by the U.S. Food \& Drug Administration (FDA) for treating Alzheimer's Disease.
This study will help find out what effects, good and/or bad, this has. The safety of this device in humans has been tested in prior research studies; however, some side effects may not yet be known.
Detailed description
Three in-person visits will occur: (1) on the week prior to the first day of stimulation visit patients will undergo brain MRI scan to collect T1, T2, DWI and resting state functional MRI (rs-fMRI), and functional Near-Infrared Spectroscopy/Electroencephalography (fNIRS/EEG) imaging. In this visit, patients and caregivers will be taught how to operate the tDCS device and will receive a unit to take home; (2) on the day after completing the first treatment period, patients will undergo a second MRI scan with the same sequences and fNIRS/EEG imaging; (3) on the day after completing the second treatment period, at the end of week 5, patients will return the tDCS device to the study team and perform a last fNIRS/EEG imaging.
At in-person visits and during treatment periods patients will be asked questions regarding tolerability and acceptability, including monitoring for side effects, as well as completing questionnaires that assess cognition and NPS. All sessions will be remotely supervised via video conference platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized double-blind cross-over clinical trial to investigate the effects of transcranial direct current stimulation (tDCS) over affective symptoms (AS) of patients with Alzheimer's disease (AD). The study will also investigate underlying neurobiological mechanisms of tDCS in AD with functional and structural neuroimaging techniques.
| Arm | Type | Receives |
|---|---|---|
| Active TDCS treatment | Experimental | Device: Transcranial direct current stimulation (tDCS)The active-tDCS treatment will consist of a constant 2mA current applied during 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. |
| Sham TDCS treatment | Sham comparator | Device: Sham tDCSSham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Individuals who are 60 years or older.
- Diagnosis of possible or probable AD according to the National Institute of Aging - Alzheimer's Association diagnostic criteria; individuals with mild cognitive impairment (MCI) due to AD, as defined by these criteria, are eligible if biomarker evidence supports the underlying AD pathology (e.g., amyloid or tau positivity in CSF or PET imaging).
- In the determination of the PI in consultation with the delegated physician(s) patient's signs/symptoms are consistent with: a Clinical Dementia Rating (CDR) of 0.5 (MCI) with biomarker evidence of AD; or a Clinical Dementia Rating score of 1-2 (mild to moderate dementia).
- Clinically meaningful AS of ADRD is defined by the presence of any affective symptom (i.e., depression, elation, anxiety, irritability, and apathy) and a total severity score on the NPI-Q ≥10.
Key exclusion criteria (9 listed)
- Unstable medical conditions (e.g. unstable angina, uncontrolled diabetes and hypertension, advanced cancer, etc.) that, in the opinion of the PI in consultation with delegated physician(s) would contraindicate study participation for safety or data quality reasons.
- Medical history of serious psychiatric disorders (i.e. bipolar disorder, schizophrenia, manic depression etc.).
- History of epilepsy.
- Metallic objects in the brain, skull, or otherwise placed where it could interfere with DCS.
- Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening;
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 (tDCS)Also: tDCSThe active-tDCS treatment will consist of a constant 2mA current applied during daily 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation. The anode electrode will be placed over the left dorsolateral prefrontal cortex (DLPFC) and the cathode electrode over the right DLPFC. | Device | Active TDCS treatment |
| Sham tDCSAlso: ControlSham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature. | Device | Sham TDCS treatment |
Primary outcome
Neuropsychiatric Inventory Questionnaire (NPI-Q) severity score
Time frame: Baseline to Day 35
A 12 item questionnaire that measures a broad range of psychiatric symptoms. Each individual item is scored from 0 to 3. Total scores range from 0 to 36, with higher scores indicating more severe symptoms.
Brief Dimensional Apathy Scale (bDAS)
Time frame: Baseline to Day 35
A 9 item scale completed by caregivers about the participant. Each item is scored from 0 to 3. Total scores range from 0-27 with a higher score indicating more severe apathy.
Caregiver version of the Irritability Questionnaire (IrQ) How often
Time frame: Baseline to Day 35
A 10 item questionnaire, and each item is scored from 0 to 3. Total scores can range from 0-30 with a higher score indicating more frequent symptoms.
Caregiver version of the Irritability Questionnaire (IrQ) How much
Time frame: Baseline to Day 35
A 10 item questionnaire, and each item is scored from 0 to 3. Total scores can range from 0-30 with a higher score indicating more severe symptoms.
Cornell Scale for Depression in Dementia (CSDD)
Time frame: Baseline to Day 35
A 19 item scale which is scored as follows: a - Unable to evaluate the sign or symptom 0 - Absent 1. - Mild or intermittent 2. - Severe Total scores range from 0-38 with a higher score indicating greater depression.
Generalized Anxiety Disorder-7 Scale (GAD-7)
Time frame: Baseline to Day 35
A 7 item scale scored as follows: 0 - Not at all 1. - Several days 2. - More than half the days 3. - Nearly every day Total scores range from 0-21 with a higher score indicating greater anxiety.
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline to Day 35
A battery of cognitive assessment tasks. Total possible score that can be achieved is between 0-30. A higher score indicating better cognition.
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 11 Feb 2026.
- Individual participant dataSharing planned: Yes. Data collected for this study will be analyzed and stored at the Glenn Bigs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio. After the study is completed, the de-identified, archived data will be transmitted to and stored at the Glenn Bigs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio, for use by other researchers including those outside of the study. Permission to transmit data to the Glenn Biggs Institute for Alzheimer's and Neurodegenerative diseases at UT Health San Antonio will be included in the informed consent.
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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.
Thiago Macedo e Cordeiro, MD, MSc principal investigator
The University of Texas Health Science Center at San Antonio
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 (tDCS) in people with Alzheimer Disease, run by The University of Texas Health Science Center at San Antonio at 1 site 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 13 inclusion and 9 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 11 Feb 2026. 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 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. 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 Thiago Macedo e Cordeiro, MD, MSc (210-450-7055, macedoecorde@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric Inventory Questionnaire (NPI-Q) severity score (time frame: Baseline to Day 35). 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?
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 11 Feb 2026.