UMIN-CTR Clinical Trial

Public title

Evaluation of efficacy of yokukansan in patients with dementia with Lewy bodies using NPI-D as an indicator.

Acronym

Examination of efficacy of yokukansan in patients with dementia with Lewy bodies

Scientific Title

Evaluation of efficacy of yokukansan in patients with dementia with Lewy bodies using NPI-D as an indicator.

Scientific Title:Acronym

Examination of efficacy of yokukansan in patients with dementia with Lewy bodies

Region

Japan

Condition

Dementia with Lewy bodies

Classification by specialty

Geriatrics

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Exploratory examination of efficacy and safety of yokukansan in patients with dementia with Lewy bodies

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

NPI-D (administered at weeks 8 after the start of treatment)

Key secondary outcomes

MMSE, Barthel Index, cerebral blood flow (administered at week 8 after the start of treatment)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Normal adult dosage is 7.5 g/day divided into 2 to 3 oral doses, and taken before or between meals. Dosage may be adjusted according to the patient's age, weight and symptoms. Administration period: 8 weeks

Interventions/Control_2

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

40

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Probable DLB patients diagnosed according to the international consensus criteria for DLB. 2) Patients with 4 or more points at least one subscale of NPI at the start of treatment 3) Patients with serum potassium levels within the standard range of the facility when measured within 6 weeks before the start of treatment 4) Patients must have the same caregiver who can transport the patient to the hospital for consultation during the study. 5) Outpatients must have a reliable caregiver at home during the entire duration of the study who can transport the patient to the hospital for consultation 6) Inpatients must have been receiving care at their respective medical facility for least 2 weeks before the start of study

Key exclusion criteria

1) Patients with malignancy, severe disease of heart, liver, renal, blood, lung and other life-threatening diseases 2) Patients who fail to meet the DSM-IV diagnostic criteria for our study, but show symptoms of BPSD due to other concomitant neurodegenerative disease, schizophrenia, bipolar disorder, major depression or other psychiatric disorders 3) Patients with delirium due to alcohol or drug addictions, metabolic poisoning, or inflammatory disease 4) Patients who are unable to take oral medications 5) Patients initiated the therapy with donepezil hydrochloride or made change in dosage and administration of the drug within 8 weeks before the start of treatment 6) Patients received drugs prohibited for concomitant use or drugs restricted in concomitant use during wash-out period, 7) Patients who took long acting antipsychotic drugs (such as haloperidol decanoate) within 4 weeks before the start of treatment 8) Patients who are determined as unfit for the study by attending physicians for reasons other than those stated above

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Kenji Toba

Organization

Kyorin University

Division name

Department of Geriatric Medicine, Kyorin University School of Medicine

Zip code

Address

6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611 JAPAN

TEL

0422-47-5511

Email

Name of contact person

1st name
Middle name
Last name	Koichi Kozaki

Organization

Kyorin University

Division name

Department of Geriatric Medicine, Kyorin University School of Medicine

Zip code

Address

6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611 JAPAN

TEL

0422-44-1917

Homepage URL

Email

kozaki-tky@umin.ac.jp

Institute

Department of Geriatric Medicine, Kyorin University School of Medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

2009

Year

04

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

Date of protocol fixation

2008

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

04

Month

01

Day

Last follow-up date

2010

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

03

Month

31

Day

Last modified on

2009

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002208