Clinical Research Center for Dementia of South Korea (CRE... | NCT01198093

Studies
Clinical Research Center for Dementia of South Korea (CREDOS)(or CRCD)

NCT01198093

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Sep 28, 2012Estimated

Enrollment

800Estimated

Phase

Not provided

Conditions

Alzheimer's Disease

Interventions

Not provided

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

Sep 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Aug 2015Estimated

Completion Date

Aug 2015Estimated

First Submitted Date

Sep 8, 2010

First Submission Date that Met QC Criteria

Sep 8, 2010

First Posted Date

Sep 9, 2010Estimated

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

Sep 26, 2012

Last Update Posted Date

Sep 28, 2012Estimated

Name	Class
Ministry of Health & Welfare, Korea	OTHER_GOV

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

The objective of this study is to present evidence-based medicine for development of clinical practice guideline through prospective study of Alzheimer's disease(AD) and mild cognitive impairment(MCI) in korea

Detailed Description

The specific aims of this study is (1) construction & maintenance of cohort for Alzheimer's disease(AD) and mild cognitive impairment(MCI); (2) study of epidemiology, rate of progression, risk factor, prognostic factor; (3) study of biomarker such as neuropsychological assessment, peripheral & CSF markers, neuroimaging(both structural & functional)

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Alzheimer's disease(AD) and mild cognitive impairment(MCI)will be enrolled in the study.
1. the diagnostic criteria of Alzheimer's disease(AD) according to DSM IV or NINCDS -ADRDA
2. the diagnostic criteria of mild cognitive impairment(MCI) A. Memory or other cognitive complaint preferably corroborated by an informant B. Objective memory impairment or other cognitive for age and education C. Largely intact general cognitive function D. Essentially preserved ADL E. Not demented

Exclusion Criteria:

Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.

Accepts Healthy Volunteers

Yes

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

Patient populatin who is suffering from memory impairment
Normal subjects matched with age and gender

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Doh K Kim, Ph.D	Contact	82-2-3410-3582		dohkwan.kim@samsung.com

Overall Officials

Name	Affiliation	Role
Doh K KIm, Ph.D	Ministry of Health and Welfare	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26845282	Derived	Lee YM, Park JM, Lee BD, Moon E, Jeong HJ, Chung YI, Kim JH, Kim HJ, Mun CW, Kim TH, Kim YH. Gray matter volumes and treatment response of psychotic symptoms to risperidone in antipsychotic-naive Alzheimer's disease patients. J Clin Psychiatry. 2016 Jan;77(1):e8-13. doi: 10.4088/JCP.14m09740.
24589036	Derived

ID	Term
D000544	Alzheimer Disease
D060825	Cognitive Dysfunction

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