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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.

Tracking Information
First Submitted Date  ICMJE March 21, 2019
First Posted Date  ICMJE March 25, 2019
Last Update Posted Date July 12, 2019
Actual Study Start Date  ICMJE March 27, 2019
Estimated Primary Completion Date February 24, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • Core Study: Change from Baseline in the CDR-SB at 18 Months [ Time Frame: Baseline, 18 months ]
  • Extension Phase: Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Month 45 ]
  • Extension Phase: Change from Core Study Baseline in CDR-SB [ Time Frame: Baseline up to Month 45 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Core Study: Change from Baseline in the CDR-SB at 18 Months [ Time Frame: Baseline, 18 months ]
  • Extension Phase: Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Month 45 ]
  • Extension Phase: Change from Core Study Baseline in CDR-SB [ Time Frame: Baseline up to Month 45 ]
  • Extension Phase: Change from Core Study Baseline in Cerebrospinal fluid (CSF) biomarkers (neurogranin, NFL, Aβ[1-42], t-tau, and p-tau) [ Time Frame: Baseline up to Month 45 ]
Change History Complete list of historical versions of study NCT03887455 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • 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 ]
  • Core Study: Change from Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months [ Time Frame: Baseline, 18 months ]
  • Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14) at 18 Months [ Time Frame: Baseline, 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Core Study: Change From Baseline in the Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) Composite [ Time Frame: Baseline, 18 months ]
  • Core Study: Change from Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months [ Time Frame: Baseline, 18 months ]
  • Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14) at 18 Months [ Time Frame: Baseline, 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Confirm Safety and Efficacy of BAN2401 in Participants With Early Alzheimer's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Early Alzheimer's Disease
Intervention  ICMJE
  • Drug: BAN2401
    10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.
  • Drug: Placebo
    Biweekly (once every 2 weeks) administered i.v. infusion.
Study Arms  ICMJE
  • Experimental: Core Study: BAN2401 10 mg/kg biweekly
    Intervention: Drug: BAN2401
  • Placebo Comparator: Core Study: Placebo
    Intervention: Drug: Placebo
  • Experimental: Extension Phase: BAN2401 10 mg/kg biweekly
    Intervention: Drug: BAN2401
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2019)
1566
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2019)
1556
Estimated Study Completion Date  ICMJE March 7, 2024
Estimated Primary Completion Date February 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com
Listed Location Countries  ICMJE Canada,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03887455
Other Study ID Numbers  ICMJE BAN2401-G000-301
2018-004739-58 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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/.
Responsible Party Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Biogen
Investigators  ICMJE Not Provided
PRS Account Eisai Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP