Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease
Completed · Not applicable
Conditions studied: Alzheimer Disease
In brief
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.
Key facts
- Study ID
- NCT05292222
- Run by
- HealthPartners Institute
- People needed
- 15
- Starts
- 2022-06-17
- Expected to finish
- 2023-11-07
- Last updated by the study team
- 2025-01-07
Who can join
Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- HealthPartners Neuroscience Center — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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