Novel Brain Stimulation Treatment for Neuropsychiatric Symptoms in Alzheimer's Disease (NCT06835283) | Clinical Trial Compass
RecruitingNot Applicable
Novel Brain Stimulation Treatment for Neuropsychiatric Symptoms in Alzheimer's Disease
United States20 participantsStarted 2026-08-01
Plain-language summary
The goal of this pilot study is to test a combination of two non-invasive brain stimulation methods, called iTBS (intermittent theta burst stimulation) and tDCS (transcranial direct current stimulation), in people with Alzheimer's Disease (AD) and related dementias (ADRD). This study will also explore whether the combined treatment shows promise for reducing neuropsychiatric symptoms like mood swings, apathy, and agitation, and will evaluate the impact of the treatment on caregivers.
The main questions the study aims to answer are:
1. Is the combined brain stimulation treatment practical and well-tolerated?
2. Do preliminary results suggest that this treatment could help manage neuropsychiatric symptoms and support a larger study?
Participants will:
* Attend nine in-person visits over three months.
* Complete one week of in-clinic brain stimulation sessions (iTBS) followed by four weeks of daily at-home brain stimulation sessions (tDCS).
* Take part in brain scans, questionnaires, and brain activity tests before and after the treatment.
This pilot study is a first step to assess whether this combined treatment approach is practical and whether it has potential to improve symptoms, laying the groundwork for larger studies in the future.
Who can participate
Age range
65 Years – 85 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
. veteran between the ages of 60 to 85
. clinical diagnosis of mild to moderate Alzheimer's disease or related dementia
. clinically significant neuropsychiatric symptoms (NPS) evidenced by a score ≥ 2 in at least one domain of the Neuropsychiatric Inventory Questionnaire
. mild to moderate cognitive impairment demonstrated by a Mini-Mental State Examination (MMSE) score of 15-23
. have a caregiver who is able and willing to escort the patient to/from clinic visits, answer questionnaires, and assist in the implementation of treatment sessions at home
. if taking psychotropic medications, demonstrate stability for at least 4 weeks of treatment
Exclusion criteria
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.
1This trial is in an early feasibility phase, meaning researchers are still figuring out whether this combined brain stimulation approach is even practical and tolerable for people with Alzheimer's-related dementia — does that mean there's less safety and effectiveness data available than there would be for a later-phase trial, and what does that mean for my loved one specifically?
2The trial combines two types of brain stimulation, iTBS and tDCS, at the same time — can you explain what each of those involves physically, how long each session lasts, and how often my loved one would need to come in, so we can figure out if the schedule is realistic for us?
3Since the main thing being measured here is whether this treatment is feasible and tolerable rather than whether it actually improves symptoms, what realistic benefit, if any, should we expect for my loved one during participation?
4Are there any neuropsychiatric symptoms — like agitation, anxiety, or sleep problems — that my loved one is experiencing that would make them a better or worse candidate for this kind of brain stimulation study?
5Before considering this trial, are there standard medications or other established treatments for the neuropsychiatric symptoms of Alzheimer's that we haven't fully tried yet, and would it make more sense to explore those first?
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
Feasibility of iTBS-tDCS treatment in ADRD patients
Timeframe: From enrollment until the end of treatment at 5 weeks
2
Tolerability of iTBS-tDCS treatment in ADRD patients
Timeframe: From enrollment until the end of treatment at 5 weeks
. any contraindication for iTBS/tDCS including but not limited to seizure disorder, severe cardiovascular disease, history of brain surgery, or stroke involving the cerebral cortex near area of stimulation
. current alcohol or substance use disorder determined by QuickSCID (nicotine allowed; mild cannabis and alcohol use is allowed)
. neuropsychiatric symptoms (NPS) that are severe enough to preclude the intervention from being delivered safely and effectively, particularly agitation or aggression.