Correlation Between Regional Brain Volume and Response to... | NCT00165750

Studies
Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

NCT00165750

Sponsor

Eisai Korea Inc.

Status

Terminated

Last Update Posted

Nov 20, 2013Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Alzheimer's Disease

Interventions

DONEPEZIL HYDROCHLORIDE

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of patients to enroll.

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Aug 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 14, 2005Estimated

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

Nov 19, 2013

Last Update Posted Date

Nov 20, 2013Estimated

Description Module

Brief Summary

This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: DONEPEZIL HYDROCHLORIDE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DONEPEZIL HYDROCHLORIDE	Drug	One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)	1

Measure	Description	Time Frame
MRI, ADAS-cog		0, 12, 24 weeks

Measure	Description	Time Frame
ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus		0, 12, 24 weeks

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Over 60 years old.
Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA.
MMSE score of 10~24, CDR of 1~2.
Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening.
Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension.

Exclusion criteria:

Uncontrolled by donepezil because of adverse events.
No longer continuing treatment of donepezil for refuse, drug-drug interaction etc.
If they have taken concomitant medication which were not allowed.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jihee Mun	Eisai Korea Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cheonnam University Hospital		Gwangju	Gwangju		South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

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