UMIN-CTR Clinical Trial

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

Alzheimer's disease

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

YES

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

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

Study type

Interventional

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

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

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

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

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

Institute

Tohoku University

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

06

Month

20

Day

Last modified on

2018

Year

06

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037711