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

NCT ID: NCT01249196

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

SK-PC-B70M

Intervention Type DRUG

for dosage

SK-PC-B70M 200mg bid

Group Type EXPERIMENTAL

SK-PC-B70M

Intervention Type DRUG

for dosage

SK-PC-B70M 300mg bid

Group Type EXPERIMENTAL

SK-PC-B70M

Intervention Type DRUG

for dosage

Donepezil

Group Type OTHER

SK-PC-B70M

Intervention Type DRUG

for dosage

Interventions

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SK-PC-B70M

for dosage

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 of 10 to 26 and CDR of 1 or 2
* AChEI or memantine was not taken at least 3 months prior to screening

Exclusion Criteria

* 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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SKChemicals invetigational site

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SMART_AD_III_2009

Identifier Type: -

Identifier Source: org_study_id