TMS Pilot in Early AD II

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.

Interventions

• Intermittent theta burst stimulation active coil · DEVICE

  MagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz

• Sham coil · DEVICE

  MagVenture TMS Therapy sham coil

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• HealthPartners Neuroscience Center, Saint Paul, Minnesota