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

Sponsor
Eisai Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01230853
Collaborator
(none)
80
Enrollment
8
Locations
4
Arms
30.1
Duration (Months)
10
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Active Comparator: A
  • Drug: Placebo Comparator B
  • Drug: Active Comparator B
  • Drug: Placebo Comparator A
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active Comparator: A

Drug: Active Comparator: A
Lecanemab 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)
Other Names:
  • BAN2401

    		•
    Placebo Comparator: Placebo Comparator A

    Drug: Placebo Comparator A
    Placebo Matching Placebo Infusion
    Active Comparator: Active Comparator: B

    Drug: Active Comparator B
    Lecanemab Multiple Dose Ascending Intravenous infusions once every 4 weeks at sequentially ascending doses (dose levels: 0.3, 1, 3, and 10 mg/kg)
    Other Names:
  • BAN2401

    		•
    Placebo Comparator: Placebo Comparator B

    Drug: Placebo Comparator B
    Placebo Matching Placebo Infusion

    Outcome Measures

    Primary Outcome Measures

    1. Single Ascending Dose (SAD) [baseline to Day 180 post-dose]

      To evaluate the safety and tolerability of single intravenous (i.v.) infusions of lecanemab at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD)

    2. Multiple Ascending Dose(MAD) [baseline to Day 264 post-dose]

      To evaluate the safety and tolerability of 4 monthly i.v. infusions of lecanemab at sequentially ascending doses in subjects with AD

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Garden Grove California United States
    2 San Francisco California United States
    3 Orlando Florida United States
    4 Atlanta Georgia United States
    5 Indianapolis Indiana United States
    6 Eatontown New Jersey United States
    7 Princeton New Jersey United States
    8 Salt Lake City Utah United States

    Sponsors and Collaborators

    • Eisai Inc.

    Investigators

    • Study Director: Eisai Medical Services, Eisai Limited

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eisai Inc.
    ClinicalTrials.gov Identifier:
    NCT01230853
    Other Study ID Numbers:
    • BAN2401-A001-101
    First Posted:
    Oct 29, 2010
    Last Update Posted:
    Nov 23, 2020
    Last Verified:
    Feb 1, 2013
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Nov 23, 2020