A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study
This study has been completed.
Sponsor:
Eisai Inc.
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
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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:
- 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.
Exclusion:
- 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.
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 May 23, 2013