A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AriBio Co., Ltd.
- Enrollment
- 210
- Locations
- 20
- Primary Endpoint
- ADAS-Cog 13
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind for study site and participants
Eligibility Criteria
- Ages
- 55 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Placebo, orally administered once daily for 26 weeks.
Intervention: Placebo (Drug)
AR1001 - 10 mg
Active, AR1001 - 10 mg, orally administered once daily for 26 weeks.
Intervention: AR1001 (Drug)
AR1001 - 30 mg
Active, AR1001 - 30 mg, orally administered once daily for 26 weeks.
Intervention: AR1001 (Drug)
Outcomes
Primary Outcomes
ADAS-Cog 13
Time Frame: 26 weeks
Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from baseline at Week 26
ADCS-CGIC
Time Frame: 26 weeks
Change of ADCS-CGIC (Alzheimer's disease Cooperative Study-Clinical Global Impression of Change)
Secondary Outcomes
- NPI(26 weeks)
- GDS(26 weeks)
- QOL-AD(26 weeks)
- C-SSRS(26 weeks)
- Treatment related adverse events(26 weeks)
- MMSE-2(26 weeks)