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TMS Pilot in Early AD II | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

TMS Pilot in Early AD II

A Preliminary Sham-Controlled Theta Burst Stimulation (TBS) Study in Early-Stage Alzheimer's Disease (AD)

NCT06817902•HealthPartners Institute

Summary

Alzheimer's disease (AD) is a progressive neurodegenerative condition affecting 6.2 million individuals in the United States, resulting in an annual cost of care of $305 billion. AD is functionally characterized by progressive degeneration of large-scale brain networks (LSBNs), including the default mode network (DMN) presumably from the deposition of amyloid plaques and neurofibrillary tangles. Available FDA-approved medications for AD such as donepezil and memantine offer limited benefit and modest impact on quality of life. Transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with AD. We propose a case series study to compare sham with iTBS.

Eligibility

Age

40 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Established diagnosis of Mild cognitive impairment (MCI)/mild AD
•Evidence for central nervous system (CNS) amyloidosis (e.g., Amyloid Positron Emission Tomography (PET) or Cerebrospinal fluid (CSF) biomarkers consistent with AD)
•Prior brain imaging performed
•Mini Mental Status Examination (MMSE) \>24
•Clinical Dementia Rating (CDR) 0.5-1
•Stable dose of cholinesterase inhibitors and memantine for at least one month
•Subjects are between 40-90 years of age

Exclusion Criteria

•Non-AD dementia including, but not limited to, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.
•Inability to tolerate resting state-function magnetic resonance imaging (rs-fMRI)
•Contraindication of rs-fMRI due to implants or metal
•Seizure disorder

Locations (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Key Dates

Start Date

December 23, 2024

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

January 7, 2026

Enrollment

ESTIMATED participants

Conditions

Alzheimer Disease

Interventions

Intermittent theta burst stimulation active coil

DEVICE

Sham coil

DEVICE

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

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Depressive SymptomsDepression+2 more

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RECRUITINGNA

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

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Alzheimer DiseaseLymphatic Obstruction

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TMS Pilot in Early AD II

Inclusion Criteria

Exclusion Criteria

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