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

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

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).

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Donepezil,; Drug: STA-1; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Donepezil plus STA-1	Drug: Donepezil,; 10mg/tab, 1 tab/day for 72 weeks; Drug: STA-1; 300mg/tab, 2 tab/tid for 72 weeks
Placebo Comparator: Donepezil plus placebo	Drug: Donepezil,; 10mg/tab, 1 tab/day for 72 weeks; Drug: placebo; 2 tab/tid for 72 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in ADAS-cog at Week 72	from baselline (Visit 2) to week 72 (Visit 9)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Mini-Mental State Examination Scale Score (MMSE) at 72 week	baseline (V2) to week 72 (Visit 8)

Collaborators and Investigators

• Sponsor: Sinphar Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Giia-Sheun Peng, MD, Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 3, 2010
• First Submitted That Met QC Criteria: December 5, 2010
• First Posted (Estimate): December 7, 2010

Study Record Updates

• Last Update Posted (Estimate): August 20, 2014
• Last Update Submitted That Met QC Criteria: August 19, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: MCCD09009A