Clinical Trial of Donepezil Between the Patients With Alz... | NCT01023867

Studies
Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia

NCT01023867

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Jan 6, 2016Estimated

Enrollment

88Actual

Phase

Not Applicable

Conditions

Alzheimer's Disease
Dementia

Interventions

donepezil

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Nov 30, 2009

First Submission Date that Met QC Criteria

Dec 1, 2009

First Posted Date

Dec 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2016

Last Update Posted Date

Jan 6, 2016Estimated

Name	Class
Eisai Korea Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.

Detailed Description

The purposes of this study are:

to compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia
to help to clinicians in choosing the best treatment for patients with mixed dementia

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alzheimer's disease group	Experimental	Patients with Alzheimer's disease treated donepezil	Drug: donepezil
Mixed Dementia group	Experimental	Patients with Mixed Dementia treated donepezil	Drug: donepezil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
donepezil	Drug	from 5mg to 10mg, once a day, 12 months	Alzheimer's disease group Mixed Dementia group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)		13 weeks, 26 weeks, 39 weeks, 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Seoul Activities of Daily Living (S-ADL)		13 weeks, 26 weeks, 39 weeks, 52 weeks
Seoul-Instrumental Activities of Daily Living (S-IADL)		13 weeks, 26 weeks, 39 weeks, 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
Korean version Mini-Mental State Examination scores between 10 and 26
History of cognitive decline that had been gradual in onset and progressive over at least 6 months
A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.

Exclusion Criteria:

they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
Cerebral injuries induced by trauma, hypoxia, and/or ischemia
Clinically active cerebrovascular disease; History of seizure disorder
Other physical conditions that required acute treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Doh Kwan Kim, PhD, M.D.	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D003704	Dementia
D000093902	Mixed Dementias

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077265	Donepezil

Ancestor Terms

ID	Term
D007189	Indans
D007192	Indenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided