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Novel Brain Stimulation Treatment for Neuropsychiatric Symptoms in Alzheimer's Disease

Sequential Accelerated ITBS / Remote tDCS for Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease: A Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 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

  • Time periods mentioned: 3 months
  • 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
  • "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."
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 small study tests two types of brain stimulation, called iTBS and tDCS, that do not need surgery. It is for veterans ages 60 to 85 with mild to moderate Alzheimer's disease or related dementia and symptoms like mood swings, low interest, or agitation. Researchers will see if the treatment is practical, is well tolerated, may ease symptoms, and affects caregivers.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a veteran age 60 to 85.
  • You have been diagnosed with mild to moderate Alzheimer's disease or a related dementia.
  • You have mood or behavior symptoms, with a score of at least 2 in one area of a study questionnaire.
  • You have mild to moderate problems with memory and thinking, with an MMSE test score of 15 to 23.
  • You have a caregiver who can take you to and from visits, answer questions, and help with home treatments.
  • If you take medicines for mood, behavior, or other mental health symptoms, your treatment has been stable for at least 4 weeks.

Who can't join

  • You have a condition or other reason that makes an MRI brain scan unsafe for you.
  • Brain stimulation is unsafe for you. Reasons include a seizure disorder, severe heart or blood vessel disease, past brain surgery, or a stroke affecting the brain's outer layer near the treatment area.
  • You have a current alcohol or drug use disorder based on a study interview. Nicotine use and mild cannabis or alcohol use are allowed.
  • Your mood or behavior symptoms, especially agitation or aggression, are too severe for treatment to be given safely and effectively.
  • You have another medical condition that is not stable and that the study doctor believes could interfere with treatment or raise the risk of harm.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria 1. veteran between the ages of 60 to 85 2. clinical diagnosis of mild to moderate Alzheimer's disease or related dementia 3. clinically significant neuropsychiatric symptoms (NPS) evidenced by a score ≥ 2 in at least one domain of the Neuropsychiatric Inventory Questionnaire 4. mild to moderate cognitive impairment demonstrated by a Mini-Mental State Examination (MMSE) score of 15-23 5. 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 6. if taking psychotropic medications, demonstrate stability for at least 4 weeks of treatment Exclusion Criteria: 1. any contraindication for MRI 2. 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 3. current alcohol or substance use disorder determined by QuickSCID (nicotine allowed; mild cannabis and alcohol use is allowed) 4. neuropsychiatric symptoms (NPS) that are severe enough to preclude the intervention from being delivered safely and effectively, particularly agitation or aggression. 6\) any unstable coexisting medical condition that in the opinion of the principal investigator(s) interferes with the treatment protocol or increase the likelihood of adverse events.

Study sites (1)

TX