Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (Polaris-AD)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

This AR1001-ADP3-US01 protocol is a double-blind, randomized, placebo-controlled, multi- center, parallel-group comparison pivotal Phase 3 study to evaluate the efficacy and safety of AR1001 for the treatment of participants with early AD.

Key facts

Study ID

NCT05531526

Run by

AriBio Co., Ltd.

People needed

1535

Starts

2022-12-23

Expected to finish

2027-12-01

Last updated by the study team

2025-10-02

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female participants aged 55 to 90 years of age inclusive at the time of signing the informed consent form
• Mild cognitive impairment or mild dementia consistent with AD defined by stages 3 to 4 according to the National Institute on Aging and Alzheimer's Association (NIA-AA) at Screening
• Participants with a history of subjective cognitive and memory decline with onset within 5 years before Screening, confirmed by study partner.
• Participants who have a MMSE score greater than or equal to 20
• Participants with a CDR global rating of 0.5 or 1
• Participants with a RBANS score based on the Delayed Memory Index (DMI) score less than or equal to 85
• If an historic magnetic resonance imaging (MRI) is available, findings must exclude other causes of dementia.
• Positive biomarker for brain amyloid pathology as indicated by assessment of at least one of the following:
• Current or historical CSF assessment with FDA-cleared assays, including Lumipulse® beta-amyloid ratio [1-42/1-40] ≤ 0.072, Elecsys® pTau 181/Aβ[1-42] greater than 0.023, Elecsys® tTau /Aβ[1-42] greater than 0.28, or other assays or cut-offs as they become FDA-cleared.
• Historical amyloid positron emission tomography (PET) assessment confirmed by the Sponsor or Designee.
• 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.

You may not qualify if…

• Participants who are female and are either pregnant, nursing, or of childbearing potential and not practicing effective contraception
• Participants who have signs of significant delirium which, in the opinion of the Investigator, would interfere with this study
• Participants who have any diagnosis of dementia or cognitive decline other than that related to AD, including, but not limited to concomitant history of significant head trauma, alcohol abuse, frontotemporal dementia, Huntington Disease, Parkinsonism (e.g., Parkinson's disease, Dementia with Lewy Bodies, etc.), significant cerebrovascular disease, and/or significant seizure disorder
• Participants with any current psychiatric diagnosis if, in the judgment of the Investigator, the psychiatric disorder (e.g., schizophrenia) or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant's ability to complete the study
• Participants with a history of vascular dementia
• Participants with evidence of other neurological conditions thought to interfere with the evaluations in this study
• Participants with a history of myocardial infarction, unstable angina, coronary artery disease, and/or New York Heart Association (NYHA) class III or IV heart failure within the last 12 months
• Participants with uncontrolled hypertension (systolic blood pressure (BP) >160 mmHg or diastolic BP > 95 mmHg) or hypotension (systolic BP <90 mmHg or diastolic BP <50 mmHg). Participants may undergo repeated testing to ensure that accurate BP readings are obtained
• Participants with a body mass index (BMI) > 35 kg/m2
• Participants with any of the following:
• elevation (>2.5x upper limit of normal [ULN]) of AST (aspartate aminotransferase, ALT (alanine transaminase, or total bilirubin (unless known prior history of Gilbert's syndrome)
• deficiency (< lower limit of normal [LLN]) of Vitamin B12
• known history of HIV (human immunodeficiency virus) positivity or positive test for HIV 1/2 at screening
• known history of Hepatitis C virus (HCV) or positive test for HCV antibody (HCVAb) at screening (unless negative on confirmatory PCR test)'
• positive test for Hepatitis B surface antigen (HBsAg)
• known history of neurosyphilis or positive test for RPR at screening
• Participants who have history of cancer or malignant tumor within 5 years prior to screening with the exception of:
• Basal or squamous cell carcinoma of the skin or cervical dysplasia, which has been adequately treated
• In situ Grade 1 cervical cancer, fully treated at least 2 years prior to screening, and without recurrence.
• Prostate cancer, confined to the prostate gland, which has been adequately treated (e.g., surgery and/or radiation or watchful waiting) with normal or low and stable prostate-specific antigen (PSA) levels for 2 years prior to Screening
• Adequately treated non-metastatic breast cancer
• Participants who in the opinion of the Investigator have an inadequately treated thyroid disorder
• Participants with inherited degenerative retinal disease
• Participants who have an undiagnosed or uncontrolled seizure disorder (and/or an epileptic syndrome), which has or could lead to cognitive impairment either from repeated seizures or the medications used to control the seizure disorder
• Participants who are being treated, or likely to require treatment during the study, with any medications prohibited by the study protocol

Where it is running

• Bezirkskrankenhaus Guenzburg — Günzburg, Germany
• Sunnybrook Health Sciences Centre — Toronto, Canada
• University Health Network-Toronto Western Hospital — Toronto, Canada
• Royal Jubilee Hospital — Victoria, Canada
• Medical Arts Health Research Group - West Vancouver — West Vancouver, Canada
• Beijing Anding Hospital Capital Medical University — Beijing, China
• Beijing Friendship Hospital,Capital Medical University — Beijing, China
• Beijing Tiantan Hospital, Capital Medical University — Beijing, China
• Peking Union Medical College Hospital — Beijing, China
• Peking University Sixth Hospital — Beijing, China
• Xuanwu Hospital Capital Medical University — Beijing, China
• The First Hospital of Jilin University — Changchun, China
• Xiangya Hospital of Central South University — Changsha, China
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China
• Guangdong Provincial People's Hospital — Guangzhou, China
• The Affiliated Brain Hospital Of Guangzhou Medical University — Guangzhou, China
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, China
• Anhui Provincial Hospital — Hefei, China
• Tianjin Medical University General Hospital — Heping, China
• The Second Affiliated Hospital of Nanchang University — Nanchang, China
• Nanjing Drum Tower Hospital — Nanjing, China
• The Second Affiliated Hospital of Nanjing Medical University — Nanjing, China
• Huashan Hospital affiliated to Fudan University — Shanghai, China
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China
• Charite Universitaetsmedizin Berlin — Berlin, Germany

Full record on ClinicalTrials.gov

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