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

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ClinicalTrials.gov Identifier: NCT03887455
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Eisai Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Early Alzheimer's Disease Drug: BAN2401 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1566 participants
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
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : February 24, 2022
Estimated Study Completion Date : March 7, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Core Study: BAN2401 10 mg/kg biweekly Drug: BAN2401
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.
Placebo Comparator: Core Study: Placebo Drug: Placebo
Biweekly (once every 2 weeks) administered i.v. infusion.
Experimental: Extension Phase: BAN2401 10 mg/kg biweekly Drug: BAN2401
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Core Study: Change from Baseline in the CDR-SB at 18 Months [ Time Frame: Baseline, 18 months ]
  2. Extension Phase: Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Month 45 ]
  3. Extension Phase: Change from Core Study Baseline in CDR-SB [ Time Frame: Baseline up to Month 45 ]

Secondary Outcome Measures :
  1. Core Study: Change from Baseline in the Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) Composite at 18 Months [ Time Frame: Baseline, 18 months ]
  2. Core Study: Change from Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months [ Time Frame: Baseline, 18 months ]
  3. Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14) at 18 Months [ Time Frame: Baseline, 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887455


Contacts
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Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com

Locations
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Sponsors and Collaborators
Eisai Inc.
Biogen
More Information
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03887455    
Other Study ID Numbers: BAN2401-G000-301
2018-004739-58 ( EudraCT Number )
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eisai Inc.:
BAN2401
Clinical Dementia Rating-Sum of Boxes
Mild cognitive impairment
 Alzheimer's disease/prodromal Alzheimer's disease
Mild Alzheimer's disease dementia
Clarity AD
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders