Advancing Alzheimer's Care: Home-based tDCS for Affective Symptoms

NCT06801639 | Recruiting FDA Device

• 1 other identifier: STUDY00001032
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease

Keywords

Transcranial direct current stimulation; TDCS; Home-based; Cognitive symptoms

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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 1. \- Mild or intermittent 2. \- Severe Total scores range from 0-38 with a higher score indicating greater depression.

  Baseline to Day 35

• Generalized Anxiety Disorder-7 Scale (GAD-7)

  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.

  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.

  Baseline to Day 35

Study Arms (2)

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.

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.

Device: Sham tDCS

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

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.

Also known as: tDCS

Active TDCS treatment

Sham tDCS DEVICE

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.

Also known as: Control

Sham TDCS treatment

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Alzheimer's Association: collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Neurobehavioral Manifestations

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Thiago Macedo e Cordeiro, MD, MSc

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thiago Macedo e Cordeiro, MD, MSc

CONTACT

210-450-7055; macedoecorde@uthscsa.edu

Antonio L Teixeira, MD, PhD

CONTACT

210-450-8636; teixeiraa@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be blinded throughout the trial. As the application of tDCS electrical current over the skin can be perceived by the participants, the study team will employ a sham condition that has been shown to be reliable and indistinguishable from active treatment in previous clinical trials published in the available scientific literature. An individual on the study team will be delegated to randomize and program and re-program devices. Participants will act as their own control. The researcher supervising the stimulation will be blinded to the intervention the participant is receiving.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When the study is completed and data is analyzed.

Locations

US (1)