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UNKNOWNPHASE2

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

NCT01255046•Sinphar Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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).

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Tri-Service General Hospital

Taipei, Taiwan

Key Dates

Start Date

December 1, 2015

Primary Completion Date

December 1, 2018

Last Updated

August 20, 2014

Enrollment

136

ESTIMATED participants

Conditions

Alzheimer Disease

Interventions

Donepezil,

DRUG

STA-1

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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