Alzheimer s DiseaseNCT07667478
NON-INVASIVE BRAIN STIMULATION FOR MEMORY LOSS IN EARLY ALZHEIMER'S DISEASE
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Alzheimer s Disease and Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, run by Chi-Ying (Roy) Lin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer s Disease, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, Mild Dementia
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 14 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shayla Yonce, BA contact
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Rory Mahabir, MBA, CCRP, 713-798-5989, rory.mahabir@bcm.edu
Chi-Ying Roy Lin, MD, MPH
About this study
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:
Read more
- 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.
Read the detailed description
Background and Rationale
- AD is a progressive neurodegenerative disorder characterized by cognitive decline, including impairments in memory. Emerging evidence suggests that the cerebellum, which is relatively spared in early AD pathology, may contribute to memory processes through its functional connectivity with cortical regions such as the posterior cingulate cortex. This raises the possibility that modulation of cerebellar activity may influence memory performance in individuals with AD.
- rTMS is a non-invasive neuromodulation technique that uses magnetic pulses to alter cortical excitability and network activity. rTMS is approved for the treatment of major depressive disorder and has been investigated in other neurological conditions. Its safety profile is well established, with commonly reported side effects including mild headache, scalp discomfort, and transient sensory effects.
- This study evaluates whether cerebellar-targeted rTMS can improve short-term memory and modulate brain activity in individuals with early AD.
Study Objectives
- The primary objective of this study is to determine whether rTMS applied to the cerebellum improves short-term memory in individuals with early AD.
- Secondary objectives include: i) evaluating changes in brain activity and functional connectivity using functional magnetic resonance imaging (fMRI), and ii) Assessing the safety and tolerability of cerebellar rTMS in this population
Study Design: this is a randomized, double-blind, sham-controlled clinical trial. Approximately 40 participants with early AD will be enrolled. Participants will be randomized in a 1:1 ratio to receive either active rTMS or sham stimulation. Both participants and study personnel involved in outcome assessment will be blinded to treatment assignment. The total duration of participation is approximately 6 months.
Study Procedures
- Screening and Baseline Assessments: At the screening visit, eligibility will be confirmed through review of medical history, current medications, and inclusion/exclusion criteria. Baseline assessments will include:
- Functional magnetic resonance imaging (fMRI)
- Cognitive and memory assessments, including standardized measures of global cognition, memory, executive function, attention, and processing speed Self-report questionnaires assessing behavioral and cognitive function Intervention Phase (rTMS Treatment)
- Cerebellar rTMS: Participants will undergo 20 rTMS sessions administered over 4 weeks (5 sessions per week). Each session will last approximately 20-30 minutes. rTMS will be applied to the cerebellum using a non-invasive magnetic stimulation device. Participants will be randomized to receive either i) Active rTMS targeting the cerebellum, or ii) Sham rTMS designed to mimic the procedure without delivering active stimulation. An fMRI scan will be conducted at the start of the intervention phase and again after completion of the 20 treatment sessions.
- Post-Treatment and Follow-Up Assessments: at the conclusion of the 20 rTMS sessions, participants will undergo repeat fMRI imaging, repeat cognitive and memory assessments.
- The above follow-up visits will occur at 3 months and 6 months post-intervention. These visits will include repeated cognitive and behavioral assessments to evaluate the durability of treatment effects.
Outcome Measures will include changes in cognitive performance (with an emphasis on memory function) and changes in brain activity and connectivity as measured by fMRI.
Safety Monitoring
- rTMS is generally well tolerated. The most commonly reported side effects include mild headache, scalp discomfort, and transient sensory effects such as facial muscle twitching or auditory discomfort. 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.
- Conditions
- Alzheimer s Disease, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, Mild Dementia
- Being tested
- repetitive transcranial magnetic stimulation (rTMS), sham repetitive transcranial magnetic stimulation rTMS
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment, Mild dementia
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS)Device
This is an early phase study investigating the effects of rTMS on individuals with early AD.
sham repetitive transcranial magnetic stimulation rTMSOther
sham rTMS
| Study group | Role | What they receive |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS) | Active comparator | cerebellar rTMS group Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
| sham | Sham comparator | Sham controlled group Receives: Other: sham repetitive transcranial magnetic stimulation rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE
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
Measured: immediate, 3-months post rTMS, 6-months post rTMS
Clinical Dementia Rating scale (CDR)
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
Measured: immediate, 3-months post rTMS, 6-months post rTMS
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
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
Measured: immediate, 3-months post rTMS, 6-months post rTMS
Verbal learning test
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
Measured: immediate, 3-months post rTMS, 6-months post rTMS
Boston Naming Test
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
Measured: immediate, 3-months post rTMS, 6-months post rTMS
Trail making test
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
Measured: immediate, 3-months post rTMS, 6-months post rTMS
Digital Span
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
Measured: immediate, 3-months post rTMS, 6-months post rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start15 Apr 2026
- Primary completion14 Apr 2031 (estimated)
- Study completion14 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chi-Ying (Roy) Lin
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Alzheimer's Research and Care Consortium
- Responsible party
- Sponsor-investigator, Chi-Ying (Roy) Lin, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667478
- Sponsor's protocol ID
- H-57537
- Status last verified
- Sep 2026
- First submitted
- 13 Jun 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: At this time, this is a pilot investigator initiated study with no intentions of sharing individual participant data with any other researchers.
Publications
Zhu Y, Liao L, Gao S, Tao Y, Huang H, Fang X, Yuan C, Gao C. Neuroprotective effects of repetitive transcranial magnetic stimulation on Alzheimer's disease: Undetermined therapeutic protocols and mechanisms. Neuroprotection. 2024 Mar 4;2(1):16-32. doi: 10.1002/nep3.40. eCollection 2024 Mar.
PubMed 41383445Kim WJ, Hahn SJ, Kim WS, Paik NJ. Neuronavigation-guided Repetitive Transcranial Magnetic Stimulation for Aphasia. J Vis Exp. 2016 May 6;(111):53345. doi: 10.3791/53345.
PubMed 27214154Shen J, Zheng J, Saxena R, Zhang C, Tang L. Novel source of human hematopoietic stem cells from peritoneal dialysis effluents. Stem Cell Res. 2015 Sep;15(2):299-304. doi: 10.1016/j.scr.2015.07.003. Epub 2015 Jul 16.
PubMed 26209817Yang L, Ge J, Ma D, Tang J, Wang H, Li Z. MoS2 quantum dots as fluorescent probe for methotrexate detection. Spectrochim Acta A Mol Biomol Spectrosc. 2022 Oct 15;279:121443. doi: 10.1016/j.saa.2022.121443. Epub 2022 May 30.
PubMed 35660152Jack CR Jr, Andrews JS, Beach TG, Buracchio T, Dunn B, Graf A, Hansson O, Ho C, Jagust W, McDade E, Molinuevo JL, Okonkwo OC, Pani L, Rafii MS, Scheltens P, Siemers E, Snyder HM, Sperling R, Teunissen CE, Carrillo MC. Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimers Dement. 2024 Aug;20(8):5143-5169. doi: 10.1002/alz.13859. Epub 2024 Jun 27.
PubMed 38934362Schwartz Z, Mashkevich G, Zeltser R. Repair of a Defect Spanning the Nasal Sill, Vestibule, and Columellar Septum. Dermatol Surg. 2024 Oct 1;50(10):963-965. doi: 10.1097/DSS.0000000000004087. Epub 2024 Jan 24. No abstract available.
PubMed 38265887Indari O, Ergun S, Karnati S, Chandra Jha H. Herpesviral interplay with peroxisome: An underexplored viral niche. Genes Dis. 2023 Mar 24;10(4):1133-1135. doi: 10.1016/j.gendis.2023.01.033. eCollection 2023 Jul.
PubMed 37397512Koti KA, Backianathan S, Sebastian P, Matthew LG, Raam M, Masih D. A Rare Case of Gastric Metastasis in Ewing's Sarcoma of the Femur. Case Rep Oncol Med. 2019 May 14;2019:2870302. doi: 10.1155/2019/2870302. eCollection 2019.
PubMed 31218087Evans MR. Will natural resistance result in populations of ash trees remaining in British woodlands after a century of ash dieback disease? R Soc Open Sci. 2019 Aug 28;6(8):190908. doi: 10.1098/rsos.190908. eCollection 2019 Aug.
PubMed 31598257Wang X, Bi Q, Lu J, Chan P, Hu X, Su L, Jessen F, Lin H, Han C, Shu N, Liu H, Han Y. Difference in Amyloid Load Between Single Memory Domain and Multidomain Subjective Cognitive Decline: A Study from the SILCODE. J Alzheimers Dis. 2022;85(4):1573-1582. doi: 10.3233/JAD-215373.
PubMed 34958039Csulak T, Hajnal A, Kiss S, Dembrovszky F, Varju-Solymar M, Sipos Z, Kovacs MA, Herold M, Varga E, Hegyi P, Tenyi T, Herold R. Implicit Mentalizing in Patients With Schizophrenia: A Systematic Review and Meta-Analysis. Front Psychol. 2022 Feb 2;13:790494. doi: 10.3389/fpsyg.2022.790494. eCollection 2022.
PubMed 35185724Facharztmagazine R. 5-Jahres-Daten der Phase-III-Studie ATTR-ACT untermauern Effektivitat von Tafamidis. MMW Fortschr Med. 2022 Feb;164(Suppl 4):50. doi: 10.1007/s15006-022-0789-z. No abstract available. German.
PubMed 35146727Nguyen V, Gao C, Hochman ML, Kravitz J, Chen EH, Friedman HI, Wenceslau CF, Chen D, Wang Y, Nelson JS, Jegga AG, Tan W. Endothelial cells differentiated from patient dermal fibroblast-derived induced pluripotent stem cells resemble vascular malformations of port-wine birthmark. Br J Dermatol. 2023 Nov 16;189(6):780-783. doi: 10.1093/bjd/ljad330.
PubMed 37672656Quattrone A, Morelli M, Bianco MG, Buonocore J, Sarica A, Caligiuri ME, Aracri F, Calomino C, De Maria M, Vaccaro MG, Gramigna V, Augimeri A, Vescio B, Quattrone A. Magnetic Resonance Planimetry in the Differential Diagnosis between Parkinson's Disease and Progressive Supranuclear Palsy. Brain Sci. 2022 Jul 20;12(7):949. doi: 10.3390/brainsci12070949.
PubMed 35884755Catania JA, Dolcini MM, Harper G, Fortenberry D, Singh RR, Jamil O, Young AW, Pollack L, Orellana ER. Oral HIV Self-Implemented Testing: Performance Fidelity Among African American MSM. AIDS Behav. 2020 Feb;24(2):395-403. doi: 10.1007/s10461-019-02711-5.
PubMed 31732830
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NON-INVASIVE BRAIN STIMULATION FOR MEMORY LOSS IN EARLY ALZHEIMER'S DISEASE
- ClinicalTrials.gov ID
- NCT07667478
- Acronym / sponsor ID
- H-57537
- Conditions
- Alzheimer s Disease, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, Mild Dementia
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment, Mild dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chi-Ying (Roy) LinUniversity, hospital or other
- Collaborators
- Texas Alzheimer's Research and Care Consortium
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 14 Apr 2031 (estimated)
- Study completion
- 14 Apr 2031 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale
- AD is a progressive neurodegenerative disorder characterized by cognitive decline, including impairments in memory. Emerging evidence suggests that the cerebellum, which is relatively spared in early AD pathology, may contribute to memory processes through its functional connectivity with cortical regions such as the posterior cingulate cortex. This raises the possibility that modulation of cerebellar activity may influence memory performance in individuals with AD.
- rTMS is a non-invasive neuromodulation technique that uses magnetic pulses to alter cortical excitability and network activity. rTMS is approved for the treatment of major depressive disorder and has been investigated in other neurological conditions. Its safety profile is well established, with commonly reported side effects including mild headache, scalp discomfort, and transient sensory effects.
- This study evaluates whether cerebellar-targeted rTMS can improve short-term memory and modulate brain activity in individuals with early AD.
Study Objectives
- The primary objective of this study is to determine whether rTMS applied to the cerebellum improves short-term memory in individuals with early AD.
- Secondary objectives include: i) evaluating changes in brain activity and functional connectivity using functional magnetic resonance imaging (fMRI), and ii) Assessing the safety and tolerability of cerebellar rTMS in this population
Study Design: this is a randomized, double-blind, sham-controlled clinical trial. Approximately 40 participants with early AD will be enrolled. Participants will be randomized in a 1:1 ratio to receive either active rTMS or sham stimulation. Both participants and study personnel involved in outcome assessment will be blinded to treatment assignment. The total duration of participation is approximately 6 months.
Study Procedures
- Screening and Baseline Assessments: At the screening visit, eligibility will be confirmed through review of medical history, current medications, and inclusion/exclusion criteria. Baseline assessments will include:
- Functional magnetic resonance imaging (fMRI)
- Cognitive and memory assessments, including standardized measures of global cognition, memory, executive function, attention, and processing speed Self-report questionnaires assessing behavioral and cognitive function Intervention Phase (rTMS Treatment)
- Cerebellar rTMS: Participants will undergo 20 rTMS sessions administered over 4 weeks (5 sessions per week). Each session will last approximately 20-30 minutes. rTMS will be applied to the cerebellum using a non-invasive magnetic stimulation device. Participants will be randomized to receive either i) Active rTMS targeting the cerebellum, or ii) Sham rTMS designed to mimic the procedure without delivering active stimulation. An fMRI scan will be conducted at the start of the intervention phase and again after completion of the 20 treatment sessions.
- Post-Treatment and Follow-Up Assessments: at the conclusion of the 20 rTMS sessions, participants will undergo repeat fMRI imaging, repeat cognitive and memory assessments.
- The above follow-up visits will occur at 3 months and 6 months post-intervention. These visits will include repeated cognitive and behavioral assessments to evaluate the durability of treatment effects.
Outcome Measures will include changes in cognitive performance (with an emphasis on memory function) and changes in brain activity and connectivity as measured by fMRI.
Safety Monitoring
- rTMS is generally well tolerated. The most commonly reported side effects include mild headache, scalp discomfort, and transient sensory effects such as facial muscle twitching or auditory discomfort. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS) | Active comparator | Device: repetitive transcranial magnetic stimulation (rTMS)cerebellar rTMS group |
| sham | Sham comparator | Other: sham repetitive transcranial magnetic stimulation rTMSSham controlled group |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)This is an early phase study investigating the effects of rTMS on individuals with early AD. | Device | repetitive transcranial magnetic stimulation (rTMS) |
| sham repetitive transcranial magnetic stimulation rTMSsham rTMS | Other | sham |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 41383445Zhu Y, Liao L, Gao S, Tao Y, Huang H, Fang X, Yuan C, Gao C. Neuroprotective effects of repetitive transcranial magnetic stimulation on Alzheimer's disease: Undetermined therapeutic protocols and mechanisms. Neuroprotection. 2024 Mar 4;2(1):16-32. doi: 10.1002/nep3.40. eCollection 2024 Mar.
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- Individual participant dataSharing planned: No. At this time, this is a pilot investigator initiated study with no intentions of sharing individual participant data with any other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shayla Yonce, BA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Alzheimer s Disease and Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, run by Chi-Ying (Roy) Lin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rory Mahabir, MBA, CCRP (713-798-5989, rory.mahabir@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE (time frame: immediate, 3-months post rTMS, 6-months post rTMS). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07667478, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.