NCT00443417

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

December 9, 2009

Status Verified

January 1, 2008

Enrollment Period

1.8 years

First QC Date

March 5, 2007

Last Update Submit

December 8, 2009

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

    30 minutes

Secondary Outcomes (11)

  • MMSE(Mini Mental State Examination)

    10 minutes

  • CDR-SB(Clinical Dementia Rating Sum of Box)

    20 minutes

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

    10 minutes

  • Delayed Word-Recall Task

    5 minute

  • Symbol Digit Modalities Test

    5 minutes

  • +6 more secondary outcomes

Study Arms (4)

1

PLACEBO COMPARATOR
Drug: SK-PC-B70M

2

ACTIVE COMPARATOR

200mg qd

Drug: SK-PC-B70M

3

ACTIVE COMPARATOR

200mg bid

Drug: SK-PC-B70M

4

ACTIVE COMPARATOR

400mg qd

Drug: SK-PC-B70M

Interventions

SK-PC-B70MDRUG

dosage, frequency

1234

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SKchemicalsI nvestigational Site

Seoul, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

SK-PC-B70M

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Seol Heui Han, MD, PhD

    Konkuk University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2007

First Posted

March 6, 2007

Study Start

April 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

December 9, 2009

Record last verified: 2008-01

Locations

KR(1)