Clinical trial for Alzheimer Disease
Official title Advancing Alzheimer's Care: Home-based tDCS for Affective Symptoms
ClinicalTrials.gov ID: NCT06801639
What this study is testing
- What it's testing
- The study wants to find out whether transcranial direct current stimulation (tDCS) can change mood or feelings in people with Alzheimer’s disease, and to learn about any good or bad effects.
- Who it's for
- Adults who have been diagnosed with Alzheimer’s disease.
- What's involved
- Participants will use a handheld tDCS device at home for 30‑minute sessions, following instructions from the research team. They will report any side effects and keep a log of their sessions.
- Time commitment
- The study lasts several weeks, with participants using the device at home each day and meeting with the research team for check‑ins and to record their experiences.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 85
You may be able to join 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
- In the determination of the PI in consultation with the delegated physician(s) patient's signs/symptoms are consistent with: a Clinical Dementia...
- Clinically meaningful AS of ADRD is defined by the presence of any affective symptom (i.e., depression, elation, anxiety, irritability, and apathy)...
You likely can't join if
- Unstable medical conditions (e.g. unstable angina, uncontrolled diabetes and hypertension, advanced cancer, etc.) that, in the opinion of the PI in...
- 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...
- Unwillingness to undergo MRI at baseline and during the Week 2 conversion period for reasons other than a confirmed medical contraindication such as...
See the full eligibility criteria
- 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
- 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
- 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,
- 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...
- 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...
- 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 1\. Any individual who does not meet all the inclusion criteria
The study team makes the final eligibility decision.
Where it is enrolling
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.