TMS Pilot in Early AD II

HealthPartners Institute

Status: Invitation-only

Conditions: Alzheimer Disease

Treatments: Device: Intermittent theta burst stimulation active coil; Device: Sham coil

Study type: Interventional

Funder types: Other

Identifiers

NCT06817902

A21-251-01

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Intermittent theta burst stimulation

Experimental group

Description:

Subjects will receive treatment with intermittent theta burst stimulation (iTBS) with the active coil. There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the 8Av region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 6-9 weeks.

Treatment:

Device: Intermittent theta burst stimulation active coil

Sham device

Sham Comparator group

Description:

Subjects will receive treatment with sham coil. There will be a total of 5 treatments over a 2-week period. Coil will be placed over the same region as the experimental group. Total participation will be 6-9 weeks. An open-label extension will be offered to participants that received the sham (control) treatment without further data collection.

Treatment:

Device: Sham coil