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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01255046
Recruitment Status : Not yet recruiting
First Posted : December 7, 2010
Last Update Posted : August 20, 2014
Information provided by (Responsible Party):
Sinphar Pharmaceutical Co., Ltd

Brief 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).

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Donepezil, Drug: STA-1 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018

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

Primary Outcome Measures :
  1. Change from baseline in ADAS-cog at Week 72 [ Time Frame: from baselline (Visit 2) to week 72 (Visit 9) ]

Secondary Outcome Measures :
  1. Change from baseline in Mini-Mental State Examination Scale Score (MMSE) at 72 week [ Time Frame: baseline (V2) to week 72 (Visit 8) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01255046

Tri-Service General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Sinphar Pharmaceutical Co., Ltd
Principal Investigator: Giia-Sheun Peng, MD Tri-Service General Hospital

Responsible Party: Sinphar Pharmaceutical Co., Ltd Identifier: NCT01255046     History of Changes
Other Study ID Numbers: MCCD09009A
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents