Last updated on July 2019

A Study to Confirm Safety and Efficacy of BAN2401 in Participants With Early Alzheimer's Disease


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Early Alzheimer's Disease
  • Age: Between 50 - 90 Years
  • Gender: Male or Female

Core Study:

Inclusion Criteria

Diagnosis

Mild Cognitive Impairment (MCI) due to Alzheimer's disease - intermediate likelihood:

  • Meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria for MCI due to Alzheimer's disease - intermediate likelihood.
  • Have a global CDR score of 0.5 and CDR Memory Box score of 0.5 or greater at Screening and Baseline

Mild Alzheimer's disease dementia:

  • Meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
  • Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of 0.5 or greater at Screening and Baseline

Key Inclusion Criteria that must be met by all participants:

  • Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory (subscale) II (WMS-IV LMII)
  • Positive biomarker for brain amyloid pathology
  • Male or female participants aged greater than or equal to (>=)50 and <=90 years, at the time of informed consent
  • Mini mental state examination (MMSE) score greater than or equal to 22 at Screening and Baseline and less than or equal to 30 at Screening and Baseline
  • Body mass index (BMI) greater than 17 and less than 35 at Screening
  • If receiving an approved Alzheimer's disease treatment such as acetylcholinesterase inhibitor (AChEIs) or memantine or both for Alzheimer's disease, must be on a stable dose for at least 12 weeks prior to Baseline. Treatment-nave participants for Alzheimer's disease can be entered into the study. Unless otherwise stated, participants must have been on stable doses of all other (ie, non-Alzheimer's disease-related) permitted concomitant medications for at least 4 weeks prior to Baseline.

Exclusion Criteria

  • Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's Alzheimer's disease
  • History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
  • Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the participant
  • Geriatric Depression Scale (GDS) score >=8 at Screening
  • Contraindications to magnetic resonance imaging (MRI) scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in skull and cardiac devices other than those approved as safe for use in MRI scanners
  • Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than Alzheimer's disease
  • Any other medical conditions (eg, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
  • Participants who have any known prior exposure to BAN2401

Extension Phase:

Inclusion Criteria:

Participants who have completed Visit 42 (Week 79) of the Core Study

Exclusion Criteria

Participants who discontinued Core Study treatment due to amyloid-related imaging abnormality edema/effusion (ARIA-E), amyloid-related imaging abnormality hemorrhage (ARIA-H), or adverse events (AEs) related to infusion reactions.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.