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

This study is currently recruiting participants.
Verified June 2013 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01767311
First received: January 8, 2013
Last updated: June 11, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: BAN2401 2.5 mg/kg
Drug: BAN2401 5.0 mg/kg
Drug: BAN2401 10 mg/kg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Change from baseline in the derived Composite Clinical Score at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 & 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAN2401 2.5 mg/kg biweekly Drug: BAN2401 2.5 mg/kg
2.5 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
Experimental: BAN2401 5.0 mg/kg biweekly Drug: BAN2401 5.0 mg/kg
5.0 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
Experimental: BAN2401 10 mg/kg biweekly Drug: BAN2401 10 mg/kg
10 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
Experimental: BAN2401 5.0 mg/kg monthly 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
Experimental: BAN2401 10 mg/kg monthly 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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. ≤15 for age 50 to 64 years
    2. ≤12 for age 65 to 69 years
    3. ≤11 for age 70 to 74 years
    4. ≤9 for age 75 to 79 years
    5. ≤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 > 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767311

Contacts
Contact: Eisai Medical Services (888) 422-4743

  Show 51 Study Locations
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Chad Swanson, PhD Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01767311     History of Changes
Other Study ID Numbers: BAN2401-G000-201
Study First Received: January 8, 2013
Last Updated: June 11, 2013
Health Authority: Italy: The Italian Medicines Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013