AR1001 for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+94 other locations

Overseen BySharon J Sha

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: AriBio Co., Ltd.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests AR1001, a medicine for early Alzheimer's Disease. It focuses on people in the early stages of Alzheimer's, aiming to improve their condition through multiple mechanisms.

Will I have to stop taking my current medications?

The trial requires that participants stop taking certain medications, such as potent inhibitors of CYP3A4, at least 14 days before starting the study. If you are on an oral cholinesterase inhibitor or memantine, your dose must be stable for at least 3 months before the trial and remain unchanged during the study.

Eligibility Criteria

Adults aged 55-90 with early Alzheimer's Disease (AD), confirmed by specific cognitive tests and biomarkers, can join this trial. They need a reliable caregiver to assist and must not have other dementia causes or severe health issues like recent heart problems, uncontrolled seizures, or certain infections.

Inclusion Criteria

I am between 55 and 90 years old.

I have mild memory loss or mild dementia due to Alzheimer's disease.

You have experienced memory and thinking problems in the last 5 years, confirmed by a study partner.

My MRI ruled out other causes for my dementia.

Participants (or participant's legally authorized representative) and caregiver(s) who can sign an informed consent to participate in the study

Participants who have one (or more) identified adult study partners(s) who, in the opinion of the Investigator, has sufficient contact with and knowledge about the participant as to be able to report knowledgably about the participant's cognition, function, behavior, and safety, and compliance with the protocol. The informant/care partner must be available by phone to provide information to the Investigator and study staff about the participant as well as agree to attend in-person clinic visits that require partner input for scale completion. The informant/care partner must be literate and provide informed consent and should be available for the duration of the study. The same informant/care partner is required to be consistent across all study visits except under rare, unavoidable circumstances (e.g., unexpected informant health crisis) that are approved by the Investigator and Sponsor

Participant Groups

The study is testing AR1001 against a placebo in people with early AD. It's a Phase 3 trial where participants are randomly assigned to either the new drug or an inactive substance without knowing which one they receive.

2Treatment groups

Active Control

Placebo Group

Group I: Group A - Active ComparatorActive Control1 Intervention

Active, AR1001 30 mg QD will be administered daily for 52 weeks during the Treatment Phase of the study. In the Extension Phase, all eligible participants who choose to participate will receive AR1001 30 mg QD for 52 weeks.

Group II: Group B - Placebo ComparatorPlacebo Group1 Intervention

Placebo QD will be administered daily for 52 weeks during the Treatment Phase of the study. In the Extension Phase, all eligible participants who choose to participate will receive AR1001 30 mg QD for 52 weeks.