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

November 25, 2013 updated by: SK Chemicals Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: SK-PC-B70M
for dosage
EXPERIMENTAL: SK-PC-B70M 200mg bid
Drug: SK-PC-B70M
for dosage
EXPERIMENTAL: SK-PC-B70M 300mg bid
Drug: SK-PC-B70M
for dosage
OTHER: Donepezil
Drug: SK-PC-B70M
for dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input)
Time Frame: 45 minutes
45 minutes
MMSE (Mini Mental State Examination)
Time Frame: 10 minutes
10 minutes
CDR-SB (Clinical Dementia Rating Sum of Box)
Time Frame: 20 minutes
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Chemicals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (ESTIMATE)

November 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART_AD_III_2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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