A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01230853
First received: October 27, 2010
Last updated: May 20, 2013
Last verified: February 2013
  Purpose

The purpose of this study will be to evaluate the safety and tolerability of BAN2401 at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD).


Condition Intervention Phase
Alzheimer's Disease
Drug: Active Comparator: A
Drug: Placebo Comparator B
Drug: Active Comparator B
Drug: Placebo Comparator A
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacodynamic Response, and Pharmacokinetics of Intravenous Infusions of BAN2401 in Subjects With Mild to Moderate Alzheimer?s Disease

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Single Ascending Dose (SAD) [ Time Frame: baseline to Day 180 post-dose ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of single intravenous (i.v.) infusions of BAN2401 at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD)

  • Multiple Ascending Dose(MAD) [ Time Frame: baseline to Day 264 post-dose ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of 4 monthly i.v. infusions of BAN2401 at sequentially ascending doses in subjects with AD


Enrollment: 80
Study Start Date: August 2010
Study Completion Date: February 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Comparator: A Drug: Active Comparator: A
BAN2401 Single Dose Ascending Single intravenous infusions at sequentially ascending doses on Day 1 (dose levels: 0.1, 0.3, 1, 3, 10, and 15 mg/kg)
Placebo Comparator: Placebo Comparator A Drug: Placebo Comparator A
Placebo Matching Placebo Infusion
Active Comparator: Active Comparator: B Drug: Active Comparator B
BAN2401 Multiple Dose Ascending Intravenous infusions once every 4 weeks at sequentially ascending doses (dose levels: 0.3, 1, 3, and 10 mg/kg)
Placebo Comparator: Placebo Comparator B Drug: Placebo Comparator B
Placebo Matching Placebo Infusion

Detailed Description:

This will be a multicenter, double-blind, randomized, placebo-controlled study in subjects with mild to moderate Alzheimer's disease. The study will comprise separate single dose ascending (SAD) and multiple dose ascending (MAD) parts designed to allow the MAD part to be initiated while the SAD part is ongoing.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Clinical diagnosis of probable mild to moderate Alzheimer's disease (AD) by National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association Alzheimer's (NINCDS-ADRDA) criteria.
  2. A Mini Mental State Examination (MMSE) score of 16 to 28, inclusive, at Screening. Subjects recruited to the first 2 SAD cohorts should have an MMSE of > 22.
  3. Where symptomatic treatment of Alzheimer's disease (AD) is clinically indicated, subjects must be on stable treatment (e.g., with an anticholinesterase inhibitor [AChEI] and/or memantine) for at least 12 weeks prior to the Screening visit.
  4. On stable doses of all other prescribed medications for at least 4 weeks prior to the screening visit.

Exclusion:

  1. Any neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's disease (AD).
  2. Any psychiatric diagnosis or symptoms, e.g hallucinations, major depression, or delusions, that could interfere with assessment of cognition in the subject.
  3. History of transient ischemic attack (TIA), stroke, or seizures within 12 months of Screening.
  4. Evidence of infection, tumor, stroke or other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain magnetic resonance imaging (MRI) at Screening.
  5. Other significant pathological findings on brain MRI at Screening, including but not limited to: more than 3 micro-hemorrhages, single macro-hemorrhage; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations or space occupying lesions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230853

Locations
United States, California
Garden Grove, California, United States
San Francisco, California, United States
United States, Florida
Orlando, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, New Jersey
Eatontown, New Jersey, United States
Princeton, New Jersey, United States
United States, Utah
Salt Lake City, UT, Utah, United States
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Eisai Medical Services Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01230853     History of Changes
Other Study ID Numbers: BAN2401-A001-101
Study First Received: October 27, 2010
Last Updated: May 20, 2013
Health Authority: 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 April 15, 2014