Start: January 15, 2019
End: June 28, 2021
What Is This Study About?
This Phase II trial will investigate the efficacy and safety of the investigational drug AR1001 in older adults with mild to moderate Alzheimer's disease for 26 weeks.
Do I Qualify To Participate in This Study?
- Diagnosis of probable mild to moderate Alzheimer's disease
- Mini-Mental State Examination Score of 16 to 26
- Magnetic resonance imaging or computed tomography scan performed within the past year, with findings consistent with an Alzheimer's disease diagnosis without any other clinically significant conditions
- One (or more) adult study partner(s) who can report about the participant's safety, compliance and adherence, cognition, function, and behavior
Must NOT have:
- Pregnant, nursing, or of childbearing potential and not practicing effective contraception
- Signs of delirium
- Cortical stroke within the past 2 years
- Diagnosis of dementia other than Alzheimer's disease, including vascular dementia
- Uncontrolled heart disease or high blood pressure
- Clinically significant kidney or liver impairment
- Cancer or a malignant tumor, untreated thyroid disorder, or a history of seizure disorder
- Taken an investigational drug within the past 30 days
- Significant abnormal result in laboratory tests
- Current psychiatric diagnosis that could interfere with study participation or results
- If taking anti-dementia drugs, must be on stable dose for at least 60 days prior to taking study drug
- Prohibited medications: alpha-1 blockers (e.g., tamsulosin), PDE5 inhibitors, nitrate agents
- History or suspected hypersensitivity to any ingredients used in the study drug
- Prescription or non-prescription medications or other products known to be moderate or potent inhibitors/inducers of the enzyme CYP3A4 (unless able to stop use for at least 3 weeks prior to receiving the study drug and throughout the study)
- Intake of grapefruit, grapefruit juice, Seville oranges or orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of study drug administration and throughout the study
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: AriBio Co., Ltd.
Source: ClinicalTrials.gov ID: NCT03625622