TMS Pilot in Early AD II

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

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.

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