A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study
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|ClinicalTrials.gov Identifier: NCT01230853|
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : November 23, 2020
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|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||August 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||February 2013|
|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 Name: 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 Name: BAN2401
|Placebo Comparator: Placebo Comparator B||
Drug: Placebo Comparator B
Placebo Matching Placebo Infusion
- Single Ascending Dose (SAD) [ Time Frame: 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)
- Multiple Ascending Dose(MAD) [ Time Frame: 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
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|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- 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.
- On stable doses of all other prescribed medications for at least 4 weeks prior to the screening visit.
- Any neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's disease (AD).
- Any psychiatric diagnosis or symptoms, e.g hallucinations, major depression, or delusions, that could interfere with assessment of cognition in the subject.
- History of transient ischemic attack (TIA), stroke, or seizures within 12 months of Screening.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230853
|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, Utah, United States|
|Study Director:||Eisai Medical Services||Eisai Limited|
|Responsible Party:||Eisai Inc.|
|Other Study ID Numbers:||
|First Posted:||October 29, 2010 Key Record Dates|
|Last Update Posted:||November 23, 2020|
|Last Verified:||February 2013|
Central Nervous System Diseases
Nervous System Diseases