TMS Pilot in Early AD II

N/AEnrolling By InvitationNCT06817902

HealthPartners Institute6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Alzheimer Disease

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Effect of TBS on cognition between and within subjects using Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)

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.

Time frame: baseline, 7 weeks