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

October 27, 2010
May 20, 2013
August 2010
October 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01230853 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study
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

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).

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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)
  • Drug: Placebo Comparator B
    Placebo Matching Placebo Infusion
  • 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)
  • Drug: Placebo Comparator A
    Placebo Matching Placebo Infusion
  • Active Comparator: Active Comparator: A
    Intervention: Drug: Active Comparator: A
  • Placebo Comparator: Placebo Comparator A
    Intervention: Drug: Placebo Comparator A
  • Active Comparator: Active Comparator: B
    Intervention: Drug: Active Comparator B
  • Placebo Comparator: Placebo Comparator B
    Intervention: Drug: Placebo Comparator B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
February 2013
October 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01230853
BAN2401-A001-101
No
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Eisai Medical Services Eisai Limited
Eisai Inc.
February 2013

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