UnknownPhase 2

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

Lead sponsor

Sinphar Pharmaceutical Co., Ltd

Assets

Donepezil / STA-1

Listed sites

Recruiting sites

Enrollment

136

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDMCCD09009A

NCT IDNCT01255046

Timeline

Milestones

Study first posted2010-12-07estimated

Last update posted2014-08-20estimated

Study start2015-12 (month precision)

Primary completion2018-12estimated (month precision)

Assets

Drug assets

Donepezil STA-1

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

2 endpoints

Primary/protocol endpoint

Change from baseline in ADAS-cog at Week 72

Time frame:from baselline (Visit 2) to week 72 (Visit 9)

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Mini-Mental State Examination Scale Score (MMSE) at 72 week

Time frame:baseline (V2) to week 72 (Visit 8)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.