Home-based tDCS for Apathy in Alzheimer's Disease (NCT04855643) | Clinical Trial Compass
TerminatedNot Applicable
Home-based tDCS for Apathy in Alzheimer's Disease
Stopped: PI moved to a new institution
United States3 participantsStarted 2021-08-20
Plain-language summary
The purpose of this study is to assess feasibility, acceptability, and safety of providing tDCS to Alzheimer's disease and related dementias (ADRD) patients with apathy and to assess the efficacy of tDCS for ADRD-related symptoms, with a primary focus on apathy.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of possible or probable ADRD according to the National Institute of Aging - Alzheimer's Association diagnostic criteria
* Mild or moderate dementia, as defined by a MMSE score between 14 and 26
* Clinically meaningful apathy for at least four weeks, clinically diagnosed according to 2018 Apathy Diagnostic Criteria or defined as Neuropsychiatric Inventory (NPI-Q) apathy score equal or above 4 (i.e., severity of 'moderate' or greater and caregiver distress 'mild' or greater).
* Stable doses of cholinesterase inhibitors, memantine and other psychotropic medications for at least three months.
Exclusion Criteria:
* Unstable medical conditions
* History of epilepsy
* Metallic objects in the brain
* Diagnosis of major depression and/or a score higher than 18 on the Cornell Scale for Depression in Dementia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Included and Who Successfully Completed the Protocol
Timeframe: through study completion (about 12 weeks)
2
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
Timeframe: Baseline
3
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
Timeframe: 2 weeks of treatment
4
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
Timeframe: 4 weeks of treatment
5
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
Timeframe: 6 weeks of treatment
6
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
Timeframe: 6 weeks post-treatment (12 weeks from baseline)
7
Trial details
NCT IDNCT04855643
SponsorThe University of Texas Health Science Center, Houston