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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: macedoecorde@uthscsa.edu
• Phone: 210-450-7055

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Blood biomarker cohort for memory disorders in older adults

  This observational cohort will collect blood samples and brain imaging data from adults 50+ with memory disorders and a small group of healthy young adults to help find biomarkers.

  Recruiting Yonsei University · Seoul, Seodamun-gu · NCT07880275

• Tau changes after hip or knee replacement surgery

  Researchers will see if brain tau changes after hip or knee surgery and whether these changes relate to inflammation and thinking abilities.

  Recruiting Uppsala University Hospital · Uppsala · NCT07871487

• Low-Dose Whole-Brain Radiation Therapy With HeLaXON 1X in Mild Alzheimer's Dementia

  This study will test whether a low-dose brain radiation treatment using HeLaXON helps people with mild Alzheimer's dementia improve or stabilize thinking and daily function.

  Recruiting ReadyCure Inc. · Cheonan, Chungcheongnam-do · NCT07863011

• Cervical lymphatic surgery to see if it helps people with mild Alzheimer’s

  We’re testing a surgical approach in people with mild Alzheimer’s to see if creating alternative neck lymph drainage routes can affect brain biomarkers and daily function.

  Recruiting at 2 sites Maliszewski Daniel · Gdansk and 1 other locations · NCT07857759

• Transcranial random noise stimulation for behavioral and psychological symptoms in Alzheimer's disease

  This trial tests whether high-frequency transcranial random noise stimulation can help people with early Alzheimer's disease who have BPSD, compared to a sham treatment.

  Recruiting Anhui Medical University · Hefei, Anhui · NCT07827196

• Testing LY4405094 in healthy people and people with Alzheimer’s disease

  This study tests LY4405094 to see if it is safe and how it behaves in the body, including how it reaches the brain fluid in healthy participants and how it affects a brain protein in people with Alzheimer's disease.

  Recruiting Phase 1 Eli Lilly and Company · Anaheim, California and 17 other locations · NCT07787182

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.