Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease

HealthPartners Institute15 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. In combination with resting state functional MRI (rs-fMRI), transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with AD. We propose a pilot trial using rs-fMRI to target dysfunctional LSBNs in early stage AD.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

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 State Examination (MMSE) \>24 * Clinical Dementia Rating (CDR) Scale 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 rs-fMRI * Contraindication of rs-fMRI due to implants or metal * Seizure disorder

Outcomes

Primary Outcomes

Change in Connectivity Measure of the TGd Parcellations.

Assessed by calculating the difference and standard deviation between follow-up and baseline of number of abnormal connections of the TGd parcellation. Range: 0-378. There are 378 possible connections of the parcellation. Higher values indicate more abnormal connections of the TGd parcellation pre and post-treatment. The change in the number of abnormal connections of the parcellation is reported.

Time frame: 9 weeks