A Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Dis... | NCT00443417

Studies
A Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease

NCT00443417

Sponsor

SK Chemicals Co., Ltd.

Status

Completed

Last Update Posted

Dec 9, 2009Estimated

Enrollment

188Estimated

Phase

Phase 2

Conditions

Alzheimer's Disease

Interventions

SK-PC-B70M

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 2008

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

Apr 2007

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Mar 5, 2007

First Submission Date that Met QC Criteria

Mar 5, 2007

First Posted Date

Mar 6, 2007Estimated

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

Dec 8, 2009

Last Update Posted Date

Dec 9, 2009Estimated

Description Module

Brief Summary

The purpose of this study is to find optimistic dose and to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate 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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

188Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Drug: SK-PC-B70M
2	Active Comparator	200mg qd	Drug: SK-PC-B70M
3	Active Comparator	200mg bid	Drug: SK-PC-B70M
4	Active Comparator	400mg qd	Drug: SK-PC-B70M

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SK-PC-B70M	Drug	dosage, frequency	1 2 3 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ADAS-cog(Alzheimer's Disease Assessment Scale-Cognitive subscale)		30 minutes

Secondary Outcomes

Measure	Description	Time Frame
MMSE(Mini Mental State Examination)		10 minutes
CDR-SB(Clinical Dementia Rating Sum of Box)		20 minutes
QOL-AD(Quality of Life in Alzheimer's Disease)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age range : 50 ~ 85 years
Clinical diagnosis of probable Alzheimer's disease (DSM-IV and NINCDS-ADRDA criteria)
MRI within the last 12 months consistent with a diagnosis of AD
MMSE score 10 to 26
AChEI or memantine was discontinued at least 3 months prior to screening

Exclusion Criteria:

Patient in mild cognitive impairment (MCI; CDR-SB <2.5)
Other central nervous disease
hypothyroidism, Vitamin B12/ Folic acid deficiency, hypercalcemia, neurosyphilis, AIDS
T.I.A or Major infarction within the last 12 months
Any serious disorder that could limit the ability of the patient to participate in the study
COPD or asthma
Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seol Heui Han, MD, PhD	Konkuk University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SKchemicalsI nvestigational Site		Seoul			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
C527801	SK-PC-B70M

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided