N/A
N=10
Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT05292222 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Change in Connectivity Measure of the TGd Parcellations. — 0.5 abnormal connections
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intermittent theta burst stimulation (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Connectivity Measure of the TGd Parcellations. |
0.5 | — |
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. 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.
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 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
Data sourced from ClinicalTrials.gov (NCT05292222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.