A Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

This study is currently recruiting participants.
Verified October 2013 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01767311
First received: January 8, 2013
Last updated: October 17, 2013
Last verified: October 2013

January 8, 2013
October 17, 2013
December 2012
October 2016   (final data collection date for primary outcome measure)
Change from baseline in the derived Composite Clinical Score at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Change from baseline in the derived Composite Clinical Score at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01767311 on ClinicalTrials.gov Archive Site
  • Change from baseline in the derived Composite Clinical Score at 18 months [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in total hippocampal volume at 6, 12, and 18 Months using volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline and 6, 12, and 18 months ] [ Designated as safety issue: No ]
  • Change from baseline at 12 and 18 months in brain amyloid levels as measured by amyloid Positron Emission Tomography (PET) [ Time Frame: Baseline and 12 and 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in the derived Composite Clinical Score at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change from baseline in total hippocampal volume at 6 months using vMRI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in total hippocampal volume at 12 months using vMRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in total hippocampal volume at 18 months using vMRI [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change from baseline at 12 months in brain amyloid levels as measured by amyloid PET [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline at 18 months in brain amyloid levels as measured by amyloid PET [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer?s Disease

This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of BAN2401 to determine clinical efficacy and to explore the dose response of BAN2401 using a composite clinical score. BAN2401-G000-201 is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of subjects and 2 dose levels (5 and 10 mg/kg) are given monthly to separate groups of subjects. Subjects will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: BAN2401 2.5 mg/kg
    2.5 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
  • Drug: BAN2401 5.0 mg/kg
    5.0 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
  • Drug: BAN2401 10 mg/kg
    10 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
  • Drug: BAN2401 5.0 mg/kg
    5.0 mg/kg monthly (once every 4 weeks) administered as a 60 minute i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401
  • Drug: BAN2401 10 mg/kg
    10 mg/kg monthly (once every 4 weeks) administered as a 60 minute i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401
  • Experimental: BAN2401 2.5 mg/kg biweekly
    2.5 mg/kg biweekly
    Intervention: Drug: BAN2401 2.5 mg/kg
  • Experimental: BAN2401 5.0 mg/kg biweekly
    5.0 mg/kg biweekly
    Intervention: Drug: BAN2401 5.0 mg/kg
  • Experimental: BAN2401 10 mg/kg biweekly
    10 mg/kg biweekly
    Intervention: Drug: BAN2401 10 mg/kg
  • Experimental: BAN2401 5.0 mg/kg monthly
    5.0 mg/kg monthly
    Intervention: Drug: BAN2401 5.0 mg/kg
  • Experimental: BAN2401 10 mg/kg monthly

    10 mg/kg monthly

    --------------------------------------------------------------------------------

    Intervention: Drug: BAN2401 10 mg/kg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
December 2016
October 2016   (final data collection date for primary outcome measure)

Key Inclusion criteria for Mild Cognitive Impairment due to Alzheimer's Disease

- intermediate likelihood:

  1. Subjects who meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment due to Alzheimer's disease - intermediate likelihood
  2. Subjects who have a CDR score of 0.5 and a Memory Box score of 0.5 or greater at Screening and Baseline
  3. Subjects who report a history of subjective memory decline with gradual onset and slow progression over the last one year before Screening; MUST be corroborated by an informant
  4. Subjects with 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 II (WMS-IV LMII):

    1. Less than or equal to 15 for age 50 to 64 years
    2. Less than or equal to 12 for age 65 to 69 years
    3. Less than or equal to 11 for age 70 to 74 years
    4. Less than or equal to 9 for age 75 to 79 years
    5. Less than or equal to 7 for age 80 to 90 years

Key Inclusion criteria for Mild Alzheimer's Disease Dementia:

  1. Subjects who meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
  2. Subjects who have a CDR score of 0.5-1.0 and a Memory Box score of 0.5 or greater at Screening and Baseline

Inclusion criteria that must be met by all subjects:

  1. Positive amyloid load as indicated by PET assessment
  2. Age between 50 and 90 years, inclusive
  3. Mini Mental State Examination (MMSE) score equal to or greater than 22, and equal to or less than 30, at Screening and Baseline
  4. Body Mass Index (BMI) less than 35 at Screening
  5. Females must not be pregnant or lactating, and specified contraceptive precautions must be followed
  6. Subjects on acetylcholinesterase inhibitor or memantine therapy for Alzheimer's disease (AD) must be on a stable dose for at least 12 weeks prior to baseline
  7. Subjects must have identified caregivers/informants
  8. Subjects must provide written informed consent

Key Exclusion criteria:

  1. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD
  2. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
  3. Any psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the subject
  4. Contraindications to 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 MR scanners
  5. Evidence of other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening, or other significant pathological findings on brain MRI at Screening
  6. A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by a repeated electrocardiogram (ECG)
  7. Certain other specified medical conditions
  8. Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately
Both
50 Years to 90 Years
No
Contact: Eisai Medical Services (888) 422-4743
United States
 
NCT01767311
BAN2401-G000-201
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Chad Swanson Eisai Inc.
Eisai Inc.
October 2013

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