NCT07667478 · Chi-Ying (Roy) Lin
NON-INVASIVE BRAIN STIMULATION FOR MEMORY LOSS IN EARLY ALZHEIMER'S DISEASE
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
repetitive transcranial magnetic stimulation (rTMS)
This is an early phase study investigating the effects of rTMS on individuals with early AD.
OTHER
sham repetitive transcranial magnetic stimulation rTMS
sham rTMS
Primary outcome measures
MMSE
Time frame: immediate, 3-months post rTMS, 6-months post rTMS
The Mini-Mental State Examination (MMSE) is a widely used 30-point cognitive assessment tool that helps assess domains such as orientation, memory, attention, language and visuospatial skills. It is often used in neurology, geriatrics and clinical research to screen for cognitive impairment and to monitor changes over time. The maximum score is 30 points. The minimum score is 0. A 27-30 score is considered normal range, though subtle cognitive issues may still exist. A 24-26 score may indicate mild cognitive concerns A 20-23 score may be suggestive of mild cognitive impairment or mild dementia A 10-19 score may be suggestive of moderate cognitive impairment A score of less than 10 may be suggestive of severe cognitive impairment
Clinical Dementia Rating scale (CDR)
Time frame: immediate, 3-months post rTMS, 6-months post rTMS
The Clinical Dementia Rating (CDR) Scale is a clinician-rated staging instrument that assesses the severity of cognitive impairment based on both patient performance and information from an informant (e.g., caregiver or family member). The maximum score is 18. The minimum score is 0. A score of 16-18 indicates severe dementia A score of 9.5-15.5 indicates moderate dementia A score of 4.5-9.0 indicates mild dementia A score of 0.5-4.0 indicates very mild impairment A score of 0 indicates no impairment
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time frame: immediate, 3-months post rTMS, 6-months post rTMS
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a measure of cognitive impairment. The maximum score if 70. The minimum score is 0. 0-10 Little or no detectable cognitive impairment 10-20 Mild cognitive impairment or very mild dementia 20-35 Mild to moderate Alzheimer's disease 35-50 Moderate to severe cognitive impairment \>50 Severe cognitive impairment
Verbal learning test
Time frame: immediate, 3-months post rTMS, 6-months post rTMS
The Verbal Learning Test measure episodic verbal memory-the ability to learn, retain, and retrieve spoken information. The maximum score is 75. The minimum score is 0. Higher scores indicate better memory retention. 60-75 Excellent learning 45-59 Average to mildly reduced 30-44 Mild to moderate impairment 15-29 Moderate impairment 0-14 Severe impairment
Boston Naming Test
Time frame: immediate, 3-months post rTMS, 6-months post rTMS
The Boston Naming Test (BNT) is a widely used neuropsychological assessment that measures confrontation naming-the ability to retrieve and produce the correct name for a visually presented object. The maximum sore is 60. The minimum score if 0. 55-60 Excellent naming ability 50-54 Average to mildly reduced 40-49 Mild naming impairment 30-39 Moderate naming impairment \<30 Significant naming impairment
Trail making test
Time frame: immediate, 3-months post rTMS, 6-months post rTMS
The Trail Making Test (TMT) is a widely used neuropsychological test that measures processing speed, visual attention, sequencing, mental flexibility, and executive function. The score is the time it takes to complete the task. Lower times are better, while longer times indicate greater impairment. The minimum score is less than 30 seconds. The maximum score is greater than 300 seconds. \<30 seconds Excellent 30-45 seconds Average 46-78 seconds Mild slowing 79-120 seconds Moderate impairment \>120 seconds Significant impairment
Digital Span
Time frame: immediate, 3-months post rTMS, 6-months post rTMS
The Digit Span test is a brief neuropsychological assessment that measures attention, concentration, immediate memory, and working memory. The maximum score if 9. The minimum score is 0. 7-9 digits Excellent attention 6 digits Average 5 digits Low average 4 digits Mild impairment ≤3 digits Significant impairment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Houston, Texas
Collaborators
Texas Alzheimer's Research and Care Consortium
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations