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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: f
View:

• 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,

Locations
United States
Texas
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Contact Information
Primary
Thiago Macedo e Cordeiro, MD, MSc
macedoecorde@uthscsa.edu
210-450-7055
Backup
Antonio L Teixeira, MD, PhD
teixeiraa@uthscsa.edu
210-450-8636
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2028-12
Participants
Target number of participants: 24
Treatments
Experimental: Active TDCS treatment
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_comparator: Sham TDCS treatment
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.
Related Therapeutic Areas
Sponsors
Collaborators: Alzheimer's Association
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov