Alzheimer'
Conditions
Interventions
Ultrasonic irradiation (Ultrasonic irradiation to the brain for 20 minutes x 3 times)
Placebo therapy
Sponsors
Tohoku University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the patients satisfy the following selection criteria are included. 1. Informed consent in writing from both patient and partner. 2. Men and women 50 years to 90 years of age. 3. Patients who are available to hospitalize for at least 6 days (Only Roll-in group). 4. All the patients need to have a partner who satisfy the following; a) living with patient and keeping contact, b) able to observe ADL and conditions of the patient, c) able to attend with the patient when the patient needs assessment, d) accepted by investigators to have a capability of medication management. 5. Diagnosed as mild Alzheimer's disease or mild cognitive impairment by DSM-5, and fulfill the "probable Alzheimer's disease" or "MCI due to Alzheimer's disease" of the NIA/AA criteria. 6. Patients with 0.5 to 1.0 points with CDR global score. 7. Patients with 20 points or more with MMSE score. 8. Diagnosed as mild Alzheimer's disease or mild cognitive impairment based on the cranial MRI taken within 48 weeks before enrollment. 9. Patients whose medications are not scheduled to change within the past 12 weeks before enrollment. Medications are prescribed as mild Alzheimer's disease or mild cognitive impairment, includes donepezil hydrochloride, galantamine hydrobromide, rivastigmine, memantine hydrochloride.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of changes of ADAS-J cog | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTomohiko Shindo
Tohoku University Department of Cardiovascular Medicine
Outcome results
None listed