Recruiting

rTMS

Sponsor:

Chi-Ying (Roy) Lin

Code:

NCT07667478

Conditions

Alzheimer s Disease

Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Mild Dementia

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

repetitive transcranial magnetic stimulation (rTMS)

sham repetitive transcranial magnetic stimulation rTMS

Study Details

Brief summary:

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.

Conditions

Alzheimer s Disease

Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Mild Dementia

Study ID

NCT07667478

Start date

Apr 15, 2026

Status verified date

Jun, 2026

Completion date

Apr 14, 2031

Anticipated

Primary completion date

Apr 14, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: repetitive transcranial magnetic stimulation (rTMS)

cerebellar rTMS group

sham comparator: sham

Sham controlled group

Interventions

repetitive transcranial magnetic stimulation (rTMS)

This is an early phase study investigating the effects of rTMS on individuals with early AD.

sham repetitive transcranial magnetic stimulation rTMS

sham rTMS

Primary outcome measure

  • MMSE [ Time Frame: immediate, 3-months post rTMS, 6-months post rTMS ]
  • Clinical Dementia Rating scale (CDR) [ Time Frame: immediate, 3-months post rTMS, 6-months post rTMS ]
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) [ Time Frame: immediate, 3-months post rTMS, 6-months post rTMS ]
  • Verbal learning test [ Time Frame: immediate, 3-months post rTMS, 6-months post rTMS ]
  • Boston Naming Test [ Time Frame: immediate, 3-months post rTMS, 6-months post rTMS ]
  • Trail making test [ Time Frame: immediate, 3-months post rTMS, 6-months post rTMS ]
  • Digital Span [ Time Frame: immediate, 3-months post rTMS, 6-months post rTMS ]

Central Contacts and Locations

Central contacts

Rory Mahabir, MBA, CCRP

713-798-5989rory.mahabir@bcm.edu

Shayla Yonce, BA

Shayla.Yonce@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Rory Mahabir, MBA, CCRP

713-798-5989rory.mahabir@bcm.edu

Principal Investigator:

Chi-Ying Roy Lin, MD, MPH

More Information

Sponsor

Chi-Ying (Roy) Lin

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Alzheimer's disease
  • Mild Cognitive Impairment
  • Mild dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Chi-Ying (Roy) Lin on 2026-06-25.