TMS Pilot in Early AD II

Launched by HEALTHPARTNERS INSTITUTE · Feb 7, 2025

Keywords

ClinConnect Summary

This is a small, early-stage study testing whether a non-drug brain stimulation technique called intermittent theta burst stimulation (iTBS) can help with thinking and memory in people with early Alzheimer’s disease or mild cognitive impairment due to Alzheimer’s. Participants are randomly assigned to receive either the active iTBS treatment or a sham (fake) device, and they won’t know which one they’re getting. The main goal is to see if real iTBS leads to better cognitive scores than the sham, measured by a brief test called RBANS, from the start to about 7 weeks. The study plans to enroll about six people and will last about 6–9 weeks per participant, with five treatment sessions over two weeks. It is taking place at HealthPartners Institute in Saint Paul, Minnesota, and results are not yet available.

Who can join? Adults roughly 40–90 years old with mild Alzheimer’s disease or mild cognitive impairment due to Alzheimer’s, and who have brain changes typical of Alzheimer’s shown on amyloid PET or CSF tests. They must have a modest level of cognitive impairment (MMSE above 24 and CDR 0.5–1) and be on a stable dose of approved dementia medicines for at least a month. They also need to be able to have an MRI scan and not have other types of dementia or a seizure disorder, among other safety criteria. The study is by invitation only, and participants may have a chance to receive the sham or active treatment, with an open-label extension offered to those who received the sham after the main study. No identifiable data will be shared with other researchers.

Gender

ALL

Eligibility criteria

• 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