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CompletedNCT00443417Updated Dec 9, 2009

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

A Phase 2 interventional study of SK-PC-B70M in Alzheimer's Disease, sponsored by SK Chemicals Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2009-12-09.

Sponsored by SK Chemicals Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 188 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

SK Chemicals Co., Ltd. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
188 participants (estimated)

Study arms

  • Placebo comparator
    1

    Drug: SK-PC-B70M

  • Active comparator
    2

    200mg qd

    Drug: SK-PC-B70M

  • Active comparator
    3

    200mg bid

    Drug: SK-PC-B70M

  • Active comparator
    4

    400mg qd

    Drug: SK-PC-B70M

Interventions

  • DrugSK-PC-B70M

    dosage, frequency

06

What researchers measure

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

07

Study locations

1 site
  • SKchemicalsI nvestigational Site
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00443417
Lead sponsor
SK Chemicals Co., Ltd.
First posted
Mar 6, 2007
Start date
Apr 2007
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Dec 9, 2009

Study contacts

Seol Heui Han, MD, PhD
principal investigator · Konkuk University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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