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NON-INVASIVE BRAIN STIMULATION FOR MEMORY LOSS IN EARLY ALZHEIMER'S DISEASE

Who can join

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

Age
55 Years to 90 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

  • Procedures mentioned: MRI scans

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
  • "MRI is non-invasive and safe for most people."
  • "MRI procedures are non-invasive and considered safe for eligible participants. * Participant eligibility will be carefully assessed to minimize risk, and safety will be monitored throughout the study."
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 study tests whether repeated magnetic brain stimulation (rTMS), done without surgery, can safely improve short-term memory in people with early Alzheimer's disease. It compares real stimulation with a look-alike treatment that does not stimulate the brain. The study lasts about 6 months, with 20 treatment sessions over 4 weeks.

The goal of this clinical trial is to learn if repetitive transcranial magnetic stimulation (rTMS), a non-invasive form of brain stimulation, can improve short-term memory in people with early Alzheimer's disease (AD). The study will also evaluate the safety of this approach. The main questions it aims to answer are: * Does rTMS applied to the cerebellum improve short-term memory in people with early AD? * How does this stimulation affect brain activity and connectivity measured by MRI? Researchers will compare active rTMS to sham rTMS (a look-alike procedure that does not deliver brain stimulation) to see if rTMS works to improve memory. Participants will: * Complete a screening visit with medical and memory assessments * Be randomly assigned to receive either active rTMS or sham rTMS (neither participants nor researchers will know the assignment during treatment) * Receive 20 rTMS sessions over 4 weeks (about 20 to 30 minutes per session) * Undergo two MRI scans, one before and one after treatment * Complete memory and thinking tests and questionnaires at baseline, immediately after treatment, and at 3- and 6-month follow-up visits Participation in the study will last about 6 months. The rTMS is generally well tolerated. The most common side effects include mild headache and scalp discomfort during treatment, which are usually short-lasting. MRI is non-invasive and safe for most people. Study procedures will be reviewed to ensure participant safety. Participants may or may not benefit directly from this study. People who receive active rTMS may experience improvement in memory. This research may help improve understanding of memory function in AD and support development of new treatments.

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

Eligibility

Who can join

  • Have early Alzheimer's disease: mild problems with memory and thinking due to Alzheimer's, or mild dementia due to Alzheimer's.
  • Have scores showing memory and thinking problems: 20–28 on the MMSE test and/or 0.5–8 on the CDR-Sum of Boxes rating scale.
  • Have a positive p-tau217 blood test confirming signs of Alzheimer's disease under the 2024 diagnostic guidelines.

Who can't join

  • Have another brain, mental health, or body condition that could cause problems with thinking and daily tasks. Examples include major blood vessel disease in the brain, alcoholism, untreated major depression, or heart, kidney, or liver failure.
  • Take certain medicines that could strongly affect thinking.
  • Have a condition that makes rTMS unsafe, including a history of seizures.
  • Have metal that cannot be removed in the head or within 12 inches of the device's magnetic coil.

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

Official eligibility criteria

Inclusion Criteria: Participants must meet all of the following inclusion criteria to be eligible for enrollment: * A clinical diagnosis of early AD, defined as either mild cognitive impairment (MCI) due to AD or mild dementia due to AD; * Evidence of cognitive impairment, characterized by a MMSE score between 20 and 28 and/or a CDR-Sum of Boxes score between 0.5 and 8, consistent with the contemporary definitions used in early AD in clinical trials; and * Biomarker confirmation of AD pathology, demonstrated by a positive plasma phosphorylated tau-217 (p-tau217) result according to the 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic guidelines. Exclusion Criteria: * Exclusion criteria include evidence of other neurological, psychiatric, or systemic conditions that could cause cognitive and functional impairments (e.g., substantial concomitant cerebrovascular disease, alcoholism, certain medications that could have a substantial effect on cognition, untreated major depressive disorder, and heart, renal or hepatic failure). * Individuals who have contraindications to receiving rTMS, including a history of seizures or any non-removable metal in their heads or within 12 inches of the TMS coil will be excluded.

Study sites (1)

TX