UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012544
Receipt number R000014680
Scientific Title A randomized study comparing effects of donepezil and galantamine in Alzheimer disease :attentional function of clinical trial
Date of disclosure of the study information 2014/01/30
Last modified on 2014/04/18 00:46:01

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Basic information

Public title

A randomized study comparing effects
of donepezil and galantamine in
Alzheimer disease :attentional function of clinical trial

Acronym

A randomized study comparing effects
of donepezil and galantamine in
Alzheimer disease

Scientific Title

A randomized study comparing effects
of donepezil and galantamine in
Alzheimer disease :attentional function of clinical trial

Scientific Title:Acronym

A randomized study comparing effects
of donepezil and galantamine in
Alzheimer disease

Region

Japan


Condition

Condition

Alzhimer disease

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine the treatment effect of both attention and motivation comparing effects donepezil to galantamine in both mild and moderate severity of Alzheimer disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Clinical assessment for spontaneity

Key secondary outcomes

1 Cognitive assessment
Mini-Mental State Examination (MMSE)
Clock drawing test
The Alzheimer Disease Assessment Scale cognitive subscale (ADAS-cog)
Frontal assessment battery (FAB)
2 Behavior assessment
Clinical assessment for spontaneity (CAS)
Neuropsychiatry Inventory Questionnaire (NPI-Q)
Quality of life-Alzheimer Disease (QOL-AD) Scale


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The patients began treatment with donepezil 3mg once a daily. The total daily dose was increased by 5mg day.

Interventions/Control_2

The patients began treatment with galantamine 4mg twice daily. The total daily dose was increased by 16 mg day to a maximum of 24 mg day.

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

60 years-old <=

Age-upper limit

95 years-old >=

Gender

Male and Female

Key inclusion criteria

A diagnosis of probable AD according to the National Institute of Neurological and Communication Disorders and Stroke Alzheimer Disease and Related Disorders Association criteria, very mild to mild , moderate functional severity, reliable informed consent could be obtained from the patient and or his her relatives, the chief caregiver is the patients family ,the patients Mini Mental State Examination score was less than 11

Key exclusion criteria

either previous history or now taking other choline inhibitors (galantamine, rivastigmine) and memantine, taking antipsychotic or antidepressant medication
,there was a previous history of mental
llness or substance abuse,either an MRI or a CT scan had revealed focal brain lesions,routine blood tests (including evaluation of serum vitamin B12 and thyroid function) were abnormal findings
, the patient has pacemaker, other findings in terms with the aims of this study

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shutaro Nakaaki

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry, Laboratory of Aging, Behavior and Cognition

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan

TEL

03-3353-1211

Email

hzi05510@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Shutaro Nakaaki

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry, Laboratory of Aging, Behavior and Cognition

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan

TEL

03-3353-1211

Homepage URL


Email

hzi05510@nifty.com


Sponsor or person

Institute

Department of Neuropsychiatry, Keio University School of Medicine,

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


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

慶應義塾大学病院(東京都)   Keio University School of Medicine (Tokyo)


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 30 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

Terminated

Date of protocol fixation

2012 Year 10 Month 22 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 31 Day

Last follow-up date

2015 Year 01 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 29 Day

Date trial data considered complete

2015 Year 03 Month 30 Day

Date analysis concluded

2015 Year 03 Month 30 Day


Other

Other related information



Management information

Registered date

2013 Year 12 Month 10 Day

Last modified on

2014 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014680


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name