Summary

for people ages 50-90 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

This study will be conducted to evaluate the efficacy of BAN2401 in participants 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 in the Core Study. This study will also evaluate the long-term safety and tolerability of BAN2401 in participants with EAD in the Extension Phase and whether the long-term effects of BAN2401 as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.

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

Keywords

Early Alzheimer's Disease BAN2401 Clinical Dementia Rating-Sum of Boxes Mild cognitive impairment Alzheimer's disease/prodromal Alzheimer's disease Mild Alzheimer's disease dementia Clarity AD Alzheimer Disease Core Study: BAN2401 10 mg/kg biweekly

Eligibility

For people ages 50-90

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-naïve 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.

Locations

  • UCSF Memory and Aging Center not yet accepting patients
    San Francisco California 94158 United States
  • Stanford University Medical Center not yet accepting patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eisai Inc.
ID
NCT03887455
Phase
Phase 3
Study Type
Interventional
Last Updated