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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443417
• Other study ID #: SMART_II_2006
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2007
• Last updated: December 8, 2009
• Start date: April 2007
• Est. completion date: January 2009

Study information

• Verified date: January 2008
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• SK-PC-B70M
dosage, frequency

Locations

Country	Name	City	State
Korea, Republic of	SKchemicalsI nvestigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADAS-cog(Alzheimer's Disease Assessment Scale-Cognitive subscale)		30 minutes	No
Secondary	MMSE(Mini Mental State Examination)		10 minutes	No
Secondary	CDR-SB(Clinical Dementia Rating Sum of Box)		20 minutes	No
Secondary	QOL-AD(Quality of Life in Alzheimer's Disease)		10 minutes	No
Secondary	Delayed Word-Recall Task		5 minute	No
Secondary	Symbol Digit Modalities Test		5 minutes	No
Secondary	Digit Backward		5 minutes	No
Secondary	Maze Task		3 minutes	No
Secondary	Digit Cancellation Task		5 minutes	No
Secondary	Verbal Fluency-Categories		1 minutes	No
Secondary	Concentration / Distractibility		1 minutes	No
Secondary	GDS		10 minutes	No