UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022860
Receipt number R000026341
Scientific Title Evaluation of cognitive, affective, olfactory functions and sleep disturbance improvement in Dementia with Lewy Bodies patients treated with Galantamine
Date of disclosure of the study information 2016/06/23
Last modified on 2016/06/23 16:08:09

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Basic information

Public title

Evaluation of cognitive, affective, olfactory functions and sleep disturbance improvement in Dementia with Lewy Bodies patients treated with Galantamine

Acronym

Evaluation of cognitive, affective, olfactory function and sleep disturbance improvement in DLB patients treated with Galantamine

Scientific Title

Evaluation of cognitive, affective, olfactory functions and sleep disturbance improvement in Dementia with Lewy Bodies patients treated with Galantamine

Scientific Title:Acronym

Evaluation of cognitive, affective, olfactory function and sleep disturbance improvement in DLB patients treated with Galantamine

Region

Japan


Condition

Condition

DLB patients

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate cogitive, affective, olfactory function, sleep disturbance improvement after treatment Galantamine in DLB patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of MMSE, HDS-R and FAB scores improvement after 1,3,6,9,12,15 months from dosage started

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We evaluate Galantamine in 8mg/day at first 4 weeks. After that, dosage increased 16mg/day.

Interventions/Control_2

Conrol patients

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

20 years-old <

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

DLB patients in our department who agreed to join our clinical trial

Key exclusion criteria

Patients treated with arrhythmia, epilepsy, bronchial asthma and severe obstructive uropathy. In addition, patients who occureed side effect of Galantamine during this clinical reseach

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Abe

Organization

Okayama University

Division name

Neurology

Zip code


Address

2-5-1, Shikatacho, Kita-ku, Okayama-shi, Okayama prefecture

TEL

086-235-7365

Email

takemoto.demekin@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Mami Takemoto

Organization

Okayama Unversity

Division name

Neurology

Zip code


Address

2-5-1, Shikatacho, Kita-ku, Okayama-shi, Okayama prefecture

TEL

086-235-7365

Homepage URL


Email

takemoto.demekin@gmail.com


Sponsor or person

Institute

Department of Neurology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Institute

Department

Personal name



Funding Source

Organization

Department of Neurology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

岡山大学病院(岡山県)


Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 23 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

Preinitiation

Date of protocol fixation

2016 Year 08 Month 18 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 01 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

2016 Year 06 Month 23 Day

Last modified on

2016 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026341


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name