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 April 2013 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: April 22, 2013
Last verified: April 2013

December 3, 2010
April 22, 2013
July 2014
December 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01255046 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: Donepezil,
    10mg/tab, 1 tab/day for 72 weeks
  • Drug: STA-1
    300mg/tab, 2 tab/tid for 72 weeks
  • Drug: placebo
    2 tab/tid for 72 weeks
  • Active Comparator: Donepezil plus STA-1
    Interventions:
    • Drug: Donepezil,
    • Drug: STA-1
  • Placebo Comparator: Donepezil plus placebo
    Interventions:
    • Drug: Donepezil,
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
136
Not Provided
December 2016   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Taiwan
 
NCT01255046
MCCD09009A
Yes
Sinphar Pharmaceutical Co., Ltd
Sinphar Pharmaceutical Co., Ltd
Not Provided
Principal Investigator: Giia-Sheun Peng, MD Tri-Service General Hospital
Sinphar Pharmaceutical Co., Ltd
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP