This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Subjects will undergo undergo a single LIFU of the target brain region
Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, United States
RECRUITINGOccurrence of Treatment Emergent Adverse Events
Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.
Time frame: baseline and 7 and days after study procedure
Cognitive Change
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time frame: baseline and 7 days after procedure
Imaging Changes
Changes in brain metabolism and connectivity using PET and fMRI
Time frame: baseline, 7 and 30 days
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