NCT01249196

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P50-P75 for phase_3

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

Study Start

First participant enrolled

May 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2010

Enrollment Period

3.3 years

First QC Date

November 23, 2010

Last Update Submit

November 25, 2013

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

    30 minutes

Secondary Outcomes (3)

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

    45 minutes

  • MMSE (Mini Mental State Examination)

    10 minutes

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

    20 minutes

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: SK-PC-B70M

SK-PC-B70M 200mg bid

EXPERIMENTAL
Drug: SK-PC-B70M

SK-PC-B70M 300mg bid

EXPERIMENTAL
Drug: SK-PC-B70M

Donepezil

OTHER
Drug: SK-PC-B70M

Interventions

SK-PC-B70MDRUG

for dosage

DonepezilPlaceboSK-PC-B70M 200mg bidSK-PC-B70M 300mg bid

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

SKChemicals invetigational 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 Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 29, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2013

Last Updated

November 26, 2013

Record last verified: 2010-11

Locations

KR(1)