TMS Pilot in Early AD II

Not Applicable

• Conditions: Alzheimer Disease

• Registration Number: NCT06817902
• Lead Sponsor: HealthPartners Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-23
• Status Verified: 2025-01
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of TBS on cognition between and within subjects using Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)	baseline, 7 weeks	Average change of RBANS total score in TMS arm compared to the average change in RBANS total score in the sham arm. Range \[-160 to 160\]. Positive comparison of TMS arm to sham arm indicates increased cognitive scores in TMS arm.

Trial Locations

Locations (1)

HealthPartners Neuroscience Center; 🇺🇸 Saint Paul, Minnesota, United States