Advancing Alzheimer's Care: Home-based tDCS for Affective Symptoms
Advancing Alzheimer's Care: Home-based tDCS (Transcranial Direct Current Stimulator) for Affective Symptoms
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "At in-person visits and during treatment periods patients will be asked questions regarding tolerability and acceptability, including monitoring for side effects, as well as completing questionnaires that assess cognition and NPS."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether 30-minute sessions of tDCS, a device that sends a weak electrical current through the head, can improve mood and feelings at home. It is for adults age 60 or older with Alzheimer's disease or mild memory and thinking problems linked to Alzheimer's. The device is not FDA-approved to treat Alzheimer's, and some side effects may not yet be known.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 60 or older and able to understand and sign a study consent form.
- Have possible or likely Alzheimer's with mild to moderate dementia, or mild memory and thinking problems with tests showing signs of Alzheimer's.
- Have mood or feeling symptoms, such as depression, anxiety, unusual excitement, irritability, or lack of interest, with a symptom severity score of at least 10 on the NPI-Q checklist.
- Have an eligible caregiver willing to attend device sessions and answer questionnaires.
- The caregiver must be an unpaid adult who can understand and give spoken consent, share information about you, answer questions, and help with sessions.
- Can speak and read English.
- Have taken the same doses of medicines for at least one month.
- Have reliable high-speed internet.
Who can't join
- Have an unstable health condition that study doctors think could make joining unsafe or affect study results.
- Have a history of a serious mental health disorder, such as bipolar disorder or schizophrenia.
- Have a history of epilepsy, a condition that causes seizures.
- Have metal in the brain, skull, or another place where it could interfere with the device.
- Have had suicidal behavior or thoughts with intent to act in the three months before screening.
- Are unwilling to have MRI scans at the start and during the week 2 transition, unless a confirmed medical reason makes MRI unsafe.
- Are currently taking part in another clinical trial that tests a treatment.
- Caregivers cannot join if they do not meet all caregiver requirements.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
TX
- University of Texas Health Science Center at San Antonio · San Antonio, TX 78229Thiago Macedo e Cordeiro, MD, MSc · Study contact · 210-450-8418 · macedoecorde@uthscsa.eduAntonio L Teixeira, MD, PhD · Study contact · 210-450-8636 · teixeiraa@uthscsa.eduMore trials in San Antonio