Unique ID issued by UMIN | UMIN000033071 |
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Receipt number | R000037711 |
Scientific Title | Clinical efficacy and safety of a trans-cranial ultrasound apparatus LD-1 in the treatment of patients with mild Alzheimer's disease |
Date of disclosure of the study information | 2018/07/01 |
Last modified on | 2018/06/20 20:43:01 |
Clinical efficacy and safety of a trans-cranial ultrasound apparatus LD-1 in the treatment of patients with mild Alzheimer's disease
Ultrasound therapy for mild Alzheimer's disease
Clinical efficacy and safety of a trans-cranial ultrasound apparatus LD-1 in the treatment of patients with mild Alzheimer's disease
Ultrasound therapy for mild Alzheimer's disease
Japan |
Alzheimer's disease
Geriatrics |
Others
YES
To exploratory assess the efficacy and safety of a trans-cranial ultrasound apparatus LD-1 in the treatment of patients with mild Alzheimer's disease.
Safety,Efficacy
Exploratory
The amount of changes of ADAS-J cog
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
2
Treatment
Device,equipment |
Ultrasonic irradiation (Ultrasonic irradiation to the brain for 20 minutes x 3 times)
Placebo therapy
50 | years-old | <= |
90 | years-old | >= |
Male and Female
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.
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.
45
1st name | |
Middle name | |
Last name | Hiroaki Shimokawa |
Tohoku University
Department of Cardiovascular Medicine
1-1 Seiryomachi, Aoba-ku, Sendai 980-8574
022-717-7152
shimo@cardio.med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Tomohiko Shindo |
Tohoku University
Department of Cardiovascular Medicine
1-1 Seiryomachi, Aoba-ku, Sendai 980-8574
022-717-7153
t-shindo@cardio.med.tohoku.ac.jp
Tohoku University
Special Funds for Education and Research from the Japanese Ministry of Education, Culture, Sports, Science and Technology, Tokyo, Japan
Japanese Governmental office
Japan
NO
2018 | Year | 07 | Month | 01 | Day |
Unpublished
Open public recruiting
2018 | Year | 03 | Month | 26 | Day |
2018 | Year | 06 | Month | 07 | Day |
2018 | Year | 06 | Month | 20 | Day |
2018 | Year | 06 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037711
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