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Completed

NCT Number: NCT00443417

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

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.

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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 2

Primary location

SKchemicalsI nvestigational Site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

SK-PC-B70M

Drug

dosage, frequency

Primary outcomes

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

    Time frame: 30 minutes

Secondary outcomes

  1. MMSE(Mini Mental State Examination)

    Time frame: 10 minutes

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

    Time frame: 20 minutes

  3. QOL-AD(Quality of Life in Alzheimer's Disease)

    Time frame: 10 minutes

  4. Delayed Word-Recall Task

    Time frame: 5 minute

  5. Symbol Digit Modalities Test

    Time frame: 5 minutes

  6. Digit Backward

    Time frame: 5 minutes

  7. Maze Task

    Time frame: 3 minutes

  8. Digit Cancellation Task

    Time frame: 5 minutes

  9. Verbal Fluency-Categories

    Time frame: 1 minutes

  10. Concentration / Distractibility

    Time frame: 1 minutes

  11. GDS

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

Dose Finding Study to Assess the Efficacy and Safety of SK-PC-B70M in Patients With Mild to Moderate Alzheimer's Disease

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2007
Registry last updated
Dec 9, 2009

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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