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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Sinphar Pharmaceutical Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Sinphar Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01255046
First received: December 3, 2010
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Alzheimer Disease
Drug: Donepezil,
Drug: STA-1
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sinphar Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Change from baseline in ADAS-cog at Week 72 [ Time Frame: from baselline (Visit 2) to week 72 (Visit 9) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in Mini-Mental State Examination Scale Score (MMSE) at 72 week [ Time Frame: baseline (V2) to week 72 (Visit 8) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 136
Study Start Date: December 2015
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255046

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

No publications provided

Responsible Party: Sinphar Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01255046     History of Changes
Other Study ID Numbers: MCCD09009A
Study First Received: December 3, 2010
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration
Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014