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Completed

NCT Number: NCT01249196

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SKChemicals invetigational site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SK-PC-B70M

Drug

for dosage

Primary outcomes

  1. ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale)

    Time frame: 30 minutes

Secondary outcomes

  1. CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input)

    Time frame: 45 minutes

  2. MMSE (Mini Mental State Examination)

    Time frame: 10 minutes

  3. CDR-SB (Clinical Dementia Rating Sum of Box)

    Time frame: 20 minutes

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2013
First posted
Nov 29, 2010
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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