Confirm Safety and Efficacy of BAN2401 Anti-Amyloid-beta Immunotherapy in Participants With Early Alzheimer's Disease (Clarity AD)

Active Trial/Not Recruiting

Purpose

The Kagan Clinical Trial Program is conducting an Eisai funded study called BAN2401 anti-amyloid-beta. The primary objective is to evaluate the efficacy of BAN2401 anti-amyloid-beta, investigational agent in subjects with early Alzheimer’s disease (EAD) compared to Placebo. The key measure used to determine if BAN2401 anti-amyloid-beta compared with placebo is the Clinical Dementia Rating–Sum of Boxes (CDR-SB) which will be used to compare change of scores from baseline to the 18-month time point. Participants will undergo an hour-long infusion every 2 weeks along with neuropsychological assessments, MRI and PETs at various time points throughout the study. The study is free and voluntary. It is approximately 18 months long, with up to 5 visits within the first 90 days of screen. This study does have an extension phase for up to 2 years after the initial 18 months have been completed or until commercial availability of BAN2401 anti-amyloid-beta or until a positive risk benefit assessment in this indication is not demonstrated. Enrollment is open to patients with a diagnosis of Mild Alzheimer’s disease or Mild Cognitive Impairment due to AD who are between the ages of 50 and 90 years old. To learn more, please call Celine Ossinalde at (310) 794-6191 or send an email to: This email address is being protected from spambots. You need JavaScript enabled to view it.. (PI: Maryam Beigi, MD, Easton Center's Katherine and Benjamin Kagan Alzheimer's Disease Treatment Dev. Program)

Source: ClinicalTrials.gov

Sponsor: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03887455

 

Condition:
Early Alzheimer's Disease

 

Study Type: Interventional (Clinical Trial)
Study Design:

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Official 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
Eligibility
Ages Eligible for Study: 50 Years to 90 Years (Adult, Older Adult)
Genders Eligible for Study: All

Contact: Celine Ossinalde at (310) 794-6191 or This email address is being protected from spambots. You need JavaScript enabled to view it. to participate in this study or for more information.

Health Professionals