Study to Confirm Safety and Efficacy of BAN2401 in Participants with Early Alzheimer's Disease (Clarity AD)

  • Study Director: Adam Boxer, MD, PhD
  • Sponsor: Eisai Inc.
  • Status: Recruiting
  • Official Study Title: A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects with Early Alzheimer’s Disease
  • ClinicalTrials.gov Identifier: NCT03887455
  • Conditions Studied: mild cognitive impairment (MCI) or mild Alzheimer’s disease (AD)
  • Intervention: BAN2401 and placebo control
  • Phase: Phase 3
  • Duration of Participation:

Purpose of the Study

The purpose of this study is to evaluate the efficacy of BAN2401 in subjects with early Alzheimer’s disease (EAD) by determining the superiority of BAN2401 compared with placebo on the change from baseline in the Clinical Dementia Rating—Sum of Boxes (CDR-SB) at 18 months of treatment.

Eligibility

Inclusion Criteria: Participants must be between 50-90 years old, meet the criteria for MCI due to AD-intermediate likelihood or probable AD dementia. Participants must have a reliable study partner who can accurately report the participant’s behavior and is able to accompany them to all study visits. Participants may take symptomatic Alzheimer’s disease medications but must be on stable doses of these medications for 3 months. Other medications permitted on the study are allowed as long as the dose is stable for 28 days prior to baseline infusion. Participants must be willing and able to have MRIs throughout the course of the study, complete cognitive testing, and maintain the infusion schedule. Participants must also have a Mini Mental State Examination (MMSE) score between 22-30, inclusive, at the time of screening and baseline. Males and all women of childbearing potential must agree to abstain from sex or use an adequate method of contraception for the duration of the study and for 28 days after the last dose of study drug.

Exclusion Criteria: Participants must not have a severe or unstable medical condition that, in the opinion of the investigator or sponsor, would interfere with the patient’s ability to complete the study assessments or would require the equivalent of institutional or hospital care. Participants also should not have a history of vascular disease affecting the brain or a history of severe brain trauma. Participants must also not have a history of significant cardiovascular, hematologic, renal, hepatic, psychiatric or autoimmune disease. Any history of malignant neoplasms within 3 years of screening will be excluded. Participants must not be currently enrolled in another clinical trial.

What to Expect

Testing: Neurological and physical examinations, MRIs, 1 amyloid PET scan or 1 lumbar puncture (if needed), cognitive testing and neuropsychiatric assessments, EKGs, blood and urine specimen collection, and vital signs.

The Frequency of Visits:

  • Screening phase: 4–5 visits within 60 days of the first infusion
  • Dose administration in the placebo-controlled period: biweekly for 18 months
  • Follow up visits after dose administration period: 3 months after the last dose

Materials Needed Before Evaluation: Meets NIA-AA core clinical criteria for probable AD dementia OR meets NIA-AA core clinical criteria for MCI due to AD-intermediate likelihood.

Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits, and participants will be reimbursed up to $50 for each scheduled visit to the clinic to help defray any incidental expenses incurred in the course of participating in this study.

Contact Information

Coordinator: Sarah Herrman[email protected], 415.476.0669
Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRC[email protected], 415.476.0661