Clinical efficacy and safety of a trans-cranial ultrasound apparatus LD-1 in the treatment of patients with mild Alzheimer's disease

Not Applicable

Recruiting

• Conditions: Alzheimer' s disease

• Registration Number: JPRN-UMIN000033071
• Lead Sponsor: Tohoku University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who do not conflict with any of the following are included. 1. Patients who are determined by investigators to be difficult to keep receiving the 20 minutes treatment. 2. Patients who are determined by investigators to be difficult to perform MRI examination. 3. Patients who have consciousness disorder with less than 12 points in GCS score. 4. Diagnosed as symptomatic cerebral infarction or cerebral hemorrhage within 12 weeks before enrollment. 5. Diagnosed as more than 5 points with Modified Hachinski Ischemic Scale. 6. Diagnosed more than 4 spots of microhemorrhages by cranial MRI examination. 7. Patients who are determined by investigators to be difficult to participate in the trial because of the severe mental disorder. 8. Patients who are determined by investigators to be difficult to participate in the trial because of severe systemic disease (heart failure, liver failure, renal failure, etc.). 9. Diagnosed as diabetic retinopathy with active fundus bleeding. 10. Diagnosed malignant tumor at the time of enrollment or had been treated for malignant tumor within 5 years before enrollment. 11. Diagnosed as drug addiction, alcoholism or having its previous history. 12. Diagnosed as epilepsy or having its previous history. 13. Patients who have artificial objects embedded in the cranium (coils, electrodes, etc.). 14. Patients who have past history of brain surgery (including endovascular treatment). 15. Patients who are planning pregnant. 16. Patients who have already participating in other clinical trials. 17. Patients who are determined by investigators to be inadequate to participate in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The amount of changes of ADAS-J cog

Secondary Outcome Measures

Name	Time	Method
The amount of changes of CDR sum of boxes, NPI-Q, J-ZBI _8, Wechsler memory scale, MMSE, Abeta levels of the cerebrospinal fluid, Ratio of the responder of ADAS-J cog