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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Aug 1, 2026 to Dec 1, 2026 Trial status changed: Recruiting → Not Yet Recruiting · Eligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 3 of 3 entries · 2 more Show 5 more changesShow less
    • Trial status changed: Recruiting → Not Yet Recruiting
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Jun 2026 to Jul 2027 Start date: Aug 11, 2025 to Aug 1, 2026 · Completion date: Sep 2026 to Aug 2027v4 Show 2 more changesShow less
    • Start date: Aug 11, 2025 to Aug 1, 2026
    • Completion date: Sep 2026 to Aug 2027
  3. Start date changed from estimate of Aug 2025 to Aug 11, 2025v3
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 2025 to Aug 2025 · Study sites: 0 to 1 · Primary completion date: Feb 2026 to Jun 2026 · 1 morev2 Show 4 more changesShow less
    • Start date: Feb 2025 to Aug 2025
    • Study sites: 0 to 1
    • Primary completion date: Feb 2026 to Jun 2026
    • Completion date: Apr 2026 to Sep 2026
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06835283
Lead Sponsor Baylor College of Medicine
Conditions Alzheimer's Disease-related Dementia, Alzheimer Disease, rTMS Stimulation
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov