Study of STA-1 as an Add-on Treatment to Donepezil

Alzheimer Disease Clinical Trial

Official title:

A Phase II Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of STA-1 as an Add-on Treatment to Donepezil in Patients With Mild to Moderate Alzheimer's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01255046
• Other study ID #: MCCD09009A
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 3, 2010
• Last updated: August 19, 2014
• Start date: December 2015

Study information

• Verified date: August 2014
• Source: Sinphar Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTaiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of STA-1 vs placebo as an add-on treatment to donepezil in patients with mild to moderate Alzheimer's Disease (AD).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Male or female patient aged = 50 years;

• Probable Alzheimer's disease diagnosed by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria;

• MMSE score between 10-26, inclusive;

• Patient has been treated with donepezil 10 mg per day for at least 3 months prior to screening;

• Patient able to participate in all study evaluations and ingest oral medication as indicated;

• Patient has a responsible caregiver who will accompany the patient to all clinic visits during the study;

• Patient and the responsible caregiver have provided written informed consent before undergoing any study procedures.

Exclusion Criteria:

• Brain image (computed tomography (CT) scan or Magnetic Resonance Imaging (MRI) done within past 12 months prior to the study) and laboratory tests to exclude secondary dementia or non-Alzheimer's dementia;

• Patient with significant clinically central nervous system illness other than AD (e.g. Parkinson's disease, Human Immunodeficiency Virus (HIV) induced dementia, Hachinski Ischaemic Score (HIS) >4) or dementia complicated by other organic disease or delirium;

• Patient with a severe or uncontrolled Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder;

• Patient suffering from cerebral disturbances following a stroke or a cerebral trauma (if the event occurred within the last 6 months);

• Patient with a history of hypersensitivity to study drugs;

• Patient who has a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine (e.g., Addison's Disease), immune, neurologic, or hematologic disease as determined by the clinical judgment of the investigator;

• Participation in any research study within the last 30 days;

• Patient with significant alcohol or drug abuse as judged by the investigator.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Donepezil,
10mg/tab, 1 tab/day for 72 weeks
• STA-1
300mg/tab, 2 tab/tid for 72 weeks
• placebo
2 tab/tid for 72 weeks

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Sinphar Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in ADAS-cog at Week 72		from baselline (Visit 2) to week 72 (Visit 9)	Yes
Secondary	Change from baseline in Mini-Mental State Examination Scale Score (MMSE) at 72 week		baseline (V2) to week 72 (Visit 8)	Yes