NCT06801639 · The University of Texas Health Science Center at San Antonio
Advancing Alzheimer's Care: Home-based tDCS for Affective Symptoms
What this study is about
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 experimental device called a tDC stimulator.
View original scientific description
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.
Interventions
DEVICE
Transcranial direct current stimulation (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.
DEVICE
Sham tDCS
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
- 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,
Exclusion criteria
- 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.
- Being an active participant in other therapeutic clinical trial. Caregiver 1\. Any individual who does not meet all the inclusion criteria
Where
- San Antonio, Texas
Collaborators
Alzheimer's Association
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2026 · Source of record for eligibility and locations