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

NCT07667478 | Recruiting FDA Device

• 1 other identifier: H-57537
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Alzheimer's disease; Mild Cognitive Impairment; Mild dementia

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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

  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

  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

  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

  immediate, 3-months post rTMS, 6-months post rTMS

Study Arms (2)

repetitive transcranial magnetic stimulation (rTMS)

ACTIVE COMPARATOR

cerebellar rTMS group

Device: repetitive transcranial magnetic stimulation (rTMS)

sham

SHAM COMPARATOR

Sham controlled group

Other: sham repetitive transcranial magnetic stimulation rTMS

Interventions

repetitive transcranial magnetic stimulation (rTMS) DEVICE

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

repetitive transcranial magnetic stimulation (rTMS)

sham repetitive transcranial magnetic stimulation rTMS OTHER

sham rTMS

sham

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chi-Ying (Roy) Lin: lead
• Texas Alzheimer's Research and Care Consortium: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Related Publications (47)

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MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Rory Mahabir, MBA, CCRP

CONTACT

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

Shayla Yonce, BA

CONTACT

Shayla.Yonce@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research coordinators will also be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 25, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 14, 2031
• Study Completion (Estimated): April 14, 2031
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)