Advancing Alzheimer's Care: Home-based tDCS for Affective Symptoms
Eligible age
60–85 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: The University of Texas Health Science Center at San Antonio
You may qualify if…
- ✓ 1. Ability of subject to understand and the willingness to sign a written informed consent document.
- ✓ 2. Individuals who are 60 years or older.
- ✓ 3. 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).
- ✓ 4. 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).
- ✓ 5. 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.
- ✓ 6. Have an eligible caregiver willing to be present during stimulation sessions and answer questionnaires (see criteria below).
- ✓ 7. Can speak and read in English.
- ✓ 8. Stable doses of medications for at least one month.
You may not qualify if…
- ✕ 1. 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.
- ✕ 2. Medical history of serious psychiatric disorders (i.e. bipolar disorder, schizophrenia, manic depression etc.).
- ✕ 3. History of epilepsy.
- ✕ 4. Metallic objects in the brain, skull, or otherwise placed where it could interfere with DCS.
- ✕ 5. 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;
- ✕ 6. 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.
- ✕ 7. Being an active participant in other therapeutic clinical trial.
- ✕ Caregiver
Where it's recruiting
San Antonio
Source: ClinicalTrials.gov · NCT06801639 · last updated 2026-02-11