Home-based tDCS for mood symptoms in Alzheimer's disease

Advancing Alzheimer's Care: Home-based tDCS (Transcranial Direct Current Stimulator) for Affective Symptoms

This research will try to see if 30-minute home-based transcranial direct current stimulation (tDCS) sessions improve mood and other affective symptoms in people 60 and older with mild-to-moderate Alzheimer's disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (Academic / other)
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT06801639 on ClinicalTrials.gov

What this trial studies

Participants receive a portable, investigational tDCS device to use at home during remotely supervised 30-minute sessions, with a sham stimulation group serving as control. Three in-person visits at the University of Texas Health Science Center at San Antonio collect baseline and post-treatment MRI, fNIRS/EEG imaging, and provide device training and return. Researchers will monitor tolerability and side effects, and collect questionnaires measuring mood, other neuropsychiatric symptoms, and cognition across two treatment periods. All home sessions are conducted under video supervision and outcomes compare active versus sham stimulation.

Who should consider this trial

Good fit: Ideal candidates are adults age 60 or older with possible or probable Alzheimer's disease (including biomarker-supported MCI due to AD) with mild-to-moderate impairment (CDR 0.5–2) and clinically meaningful affective symptoms (NPI-Q severity ≥10), who can consent or have a proxy, have caregiver support, and can attend three in-person visits and participate in remote video sessions.

Not a fit: Patients without clinically significant affective symptoms, with more advanced dementia beyond mild-to-moderate stages, with contraindications to MRI or tDCS, or who cannot participate in remote video-supervised sessions or travel to the study site are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, home-based tDCS could reduce depression, anxiety, apathy and other affective symptoms in people with Alzheimer's, improving daily functioning and easing caregiver burden.

How similar studies have performed: Small prior studies of tDCS for mood or cognitive symptoms in Alzheimer's and related disorders have produced mixed but sometimes promising results, so the approach is relatively novel with some early supporting data.

Eligibility criteria

Inclusion Criteria:

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.
9. Access to a reliable broadband internet connection.

Caregiver

1. An adult who serves as an unpaid caregiver for an individual enrolled in the study as interpreted by the PI or delegate physician.
2. Adequate cognitive capacity to provide verbal consent to participate in the caregiver arm of the study.
3. 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:

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

1\. Any individual who does not meet all the inclusion criteria

Where this trial is running

San Antonio, Texas

• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Thiago Macedo e Cordeiro, MD, MSc — The University of Texas Health Science Center at San Antonio
• Study coordinator: Thiago Macedo e Cordeiro, MD, MSc

Conditions Alzheimer Disease; Transcranial direct current stimulation; TDCS; Home-based; Cognitive symptoms