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

NCT01255046 | Unknown Phase 2 DMC

• 1 other identifier: MCCD09009A
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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).

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in ADAS-cog at Week 72

  from baselline (Visit 2) to week 72 (Visit 9)

Secondary Outcomes (1)

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

  baseline (V2) to week 72 (Visit 8)

Study Arms (2)

Donepezil plus STA-1

ACTIVE COMPARATOR

Drug: Donepezil,; Drug: STA-1

Donepezil plus placebo

PLACEBO COMPARATOR

Drug: Donepezil,; Drug: placebo

Interventions

Donepezil, DRUG

10mg/tab, 1 tab/day for 72 weeks

Donepezil plus STA-1; Donepezil plus placebo

STA-1 DRUG

300mg/tab, 2 tab/tid for 72 weeks

Donepezil plus STA-1

placebo DRUG

2 tab/tid for 72 weeks

Donepezil plus placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinphar Pharmaceutical Co., Ltd: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Giia-Sheun Peng, MD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 7, 2010
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

TW (1)