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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033071
Receipt No. 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

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Basic information
Public title Clinical efficacy and safety of a trans-cranial ultrasound apparatus LD-1 in the treatment of patients with mild Alzheimer's disease
Acronym Ultrasound therapy for mild Alzheimer's disease
Scientific Title Clinical efficacy and safety of a trans-cranial ultrasound apparatus LD-1 in the treatment of patients with mild Alzheimer's disease
Scientific Title:Acronym Ultrasound therapy for mild Alzheimer's disease
Region
Japan

Condition
Condition Alzheimer's disease
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The amount of changes of ADAS-J cog
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Ultrasonic irradiation (Ultrasonic irradiation to the brain for 20 minutes x 3 times)
Interventions/Control_2 Placebo therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key 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.
Key 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.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Shimokawa
Organization Tohoku University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryomachi, Aoba-ku, Sendai 980-8574
TEL 022-717-7152
Email shimo@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiko Shindo
Organization Tohoku University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1 Seiryomachi, Aoba-ku, Sendai 980-8574
TEL 022-717-7153
Homepage URL
Email t-shindo@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Special Funds for Education and Research from the Japanese Ministry of Education, Culture, Sports, Science and Technology, Tokyo, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 20 Day
Last modified on
2018 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037711

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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