Baseline characteristics of patients with early Alzheimer's disease enrolled in the pivotal trial of low-intensity pulsed ultrasound (LIPUS-AD).

ABSTRACT:

Background

We demonstrated that low-intensity pulsed ultrasound (LIPUS) therapy tended to ameliorate cognitive declines in patients with early Alzheimer's disease (AD) in the pilot trial. Thus, we have started the pivotal trial in a randomized, double-blind, placebo-controlled manner (LIPUS-AD).

Objective

We here report the clinical characteristics of AD patients enrolled in the trial.

Methods

The major inclusion criteria included age 50-90 years of both sex, Clinical Dementia Rating (CDR) global score of 0.5∼1.0 and Japanese version of the Mini-Mental State Examination (MMSE-J) score greater than 20 at screening, positive brain Aβ-PET, and no symptomatic brain hemorrhage, infarction, or edema on brain MRI.

Results

A total of 231 subjects were finally enrolled.

SUBMITTER: Shimokawa H 

PROVIDER: S-EPMC12748502 | biostudies-literature | 2025 Jan-Dec

REPOSITORIES: biostudies-literature