Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease
- Conditions
- Mild to Moderate Alzheimer's Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT03625622
- Lead Sponsor
- AriBio Co., Ltd.
- Brief Summary
A double-blinded, randomized, placebo-controlled study will be performed to evaluate the efficacy and safety of treating AR1001 in patients with mild to moderate Alzheimer's disease for 26 weeks.
- Detailed Description
Alzheimer's Disease (AD) is the most prevalent neurodegenerative disorder in The United States affecting approximately 5.4 million Americans. AD is characterized by progressive loss in memory and as well as a decline in the ability to learn that is associated with neuronal death. Well known hallmarks of AD are neuritic plaques and neurofibrillary tangles and extensive inflammation. Currently, no treatment has been developed to fully cure or prevent the progression of dementia that is associated with AD.
AR1001 is a polypharmacological drug candidate being developed as a treatment for AD and shows great potential with favorable attributes for a central nervous system (CNS) drug (i.e., high specificity and potency, as well as good pharmacokinetic, bioavailability, CNS penetration, and ensured safety).
The clinical study of AR1001 aims to evaluate the efficacy and safety of AR1001 as a potential treatment for AD. Based on the preclinical results, AR1001 could be an effective treatment option with a mechanism of action that has not been explored for AD indication.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo, orally administered once daily for 26 weeks. AR1001 - 10 mg AR1001 Active, AR1001 - 10 mg, orally administered once daily for 26 weeks. AR1001 - 30 mg AR1001 Active, AR1001 - 30 mg, orally administered once daily for 26 weeks.
- Primary Outcome Measures
Name Time Method ADAS-Cog 13 26 weeks Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from baseline at Week 26
ADCS-CGIC 26 weeks Change of ADCS-CGIC (Alzheimer's disease Cooperative Study-Clinical Global Impression of Change)
- Secondary Outcome Measures
Name Time Method NPI 26 weeks Changes of NPI (Neuropsychiatric Inventory) from baseline at Week 26
GDS 26 weeks Changes of GDS (Geriatric Depression Scale) from baseline at Week 26
QOL-AD 26 weeks Changes of QOL-AD (Quality of Life in Alzheimer's Disease) from baseline at Week 26
C-SSRS 26 weeks Changes of C-SSRS (Columbia Suicide Severity Rating Scale) from baseline at Week 26
Treatment related adverse events 26 weeks Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results
MMSE-2 26 weeks Change of MMSE (Mini-mental status examination) from baseline at Week 26
Related Research Topics
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Trial Locations
- Locations (20)
Advanced Clinical Research, Inc.
🇺🇸West Jordan, Utah, United States
Northern California Research
🇺🇸Sacramento, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Meridien Research
🇺🇸Lakeland, Florida, United States
Meridien - Maitland
🇺🇸Maitland, Florida, United States
The Neurology Research Group
🇺🇸Miami, Florida, United States
Accelerated Enrollment Solutions (AES)
🇺🇸Orlando, Florida, United States
IMIC, Inc
🇺🇸Palmetto Bay, Florida, United States
Meridien Research - St Petersburg
🇺🇸Saint Petersburg, Florida, United States
Meridien Research - Spring Hill
🇺🇸Spring Hill, Florida, United States
Scroll for more (10 remaining)Advanced Clinical Research, Inc.🇺🇸West Jordan, Utah, United States