BAN2401 for Early Alzheimer's Disease
BAN2401 for Early Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
This study will test the effectiveness of the experimental drug BAN2401 as a possible treatment for people with mild cognitive impairment (MCI) or mild Alzheimer's disease.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | 90 Years | Both | No |
Inclusion Criteria:
- Positive amyloid load as indicated by PET brain scan
- MMSE score of 22-30 inclusive at screening and beginning of trial
- Body mass index of less than 35
- Women must not be pregnant or lactating, and specified contraceptive precautions must be followed.
- If taking acetylcholinesterase inhibitor or memantine, must be on a stable dose for at least 12 weeks
- Available, identified caregiver
- Intermediate likelihood of MCI according to National Institute of Aging-Alzheimer's Association (NIA-AA) core clinical criteria
- Clinical Dementia Rating score of 0.5; Memory Box score of 0.5 or greater
- History of subjective memory decline, with gradual onset and slow progression during the year before screening, corroborated by a family member or friend
- Objective impairment in episodic memory, as indicated by the Wechsler Memory Scale, 4th edition
- Probable Alzheimer's dementia according to NIA-AA core clinical criteria
- Clinical Dementia Rating score of 0.5-1.0; Memory Box score of 0.5 or greater
All Participants
Participants with Mild Cognitive Impairment due to Alzheimer's
Participants with Mild Alzheimer's Dementia
Exclusion Criteria:
- Any neurological condition besides Alzheimer's disease that may be contributing to cognitive impairment
- History of transient ischemic attack (TIA), stroke, or seizure within 12 months of screening
- Any psychiatric diagnosis or symptoms (for example, hallucinations, major depression, or delusions) that could interfere with study procedures
- Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator or magnetic metal implants
- MRI evidence of clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's disease or other significant pathological findings
- Prolonged QT/QTc interval (QTc > 450 ms) as shown by a repeated electrocardiogram (ECG)
- Severe visual or hearing impairment that would prevent accurate performance on psychometric tests
Detailed Description:
This 18-month, Phase II study will test the effectiveness of the experimental drug BAN2401 as a possible treatment for people with mild cognitive impairment (MCI) or mild Alzheimer's disease. BAN2401 is a monoclonal antibody that binds to large oligomers, called protofibrils, and neutralizes their damage to brain cells. Five different dose levels will be tested, including three different doses (2.5, 5, and 10 mg/kg) given every 2 weeks and two different doses (5 and 10 mg/kg) given monthly. During the study, frequent interim analyses will be conducted to guide subsequent randomization of participants into dose groups.
Central Contact Information:
For more information about this study or study locations, contact Eisai Medical Services at 1-888-422-4743.
Locations:
| Map Marker | City | State | Status | |
|---|---|---|---|---|
Geolocation is 33.4483771, -112.0740373 | Site | Phoenix | Arizona | Recruiting |
Geolocation is 32.2217429, -110.926479 | Site | Tucson | Arizona | Recruiting |
Geolocation is 33.7922392, -118.3150722 | Site | Lomita | California | Recruiting |
Geolocation is 33.768321, -118.1956168 | Site | Long Beach | California | Recruiting |
Geolocation is 33.8030716, -118.0725641 | Site | Los Alamitos | California | Recruiting |
Geolocation is 34.1975048, -119.1770516 | Site | Oxnard | California | Recruiting |
Geolocation is 39.737567, -104.9847179 | Site | Denver | Colorado | Recruiting |
Geolocation is 41.308274, -72.9278835 | Site | New Haven | Connecticut | Recruiting |
Geolocation is 26.5909025, -80.1008762 | Site | Atlantis | Florida | Recruiting |
Geolocation is 26.3586885, -80.0830984 | Site | Boca Raton | Florida | Recruiting |
Geolocation is 27.4989278, -82.5748194 | Site | Bradenton | Florida | Recruiting |
Geolocation is 26.3184123, -80.0997657 | Site | Deerfield Beach | Florida | Recruiting |
Geolocation is 26.4614625, -80.0728201 | Site | Delray Beach | Florida | Recruiting |
Geolocation is 26.640628, -81.8723084 | Site | Fort Meyers | Florida | Recruiting |
Geolocation is 25.9812024, -80.148379 | Site | Hallandale Beach | Florida | Recruiting |
Geolocation is 25.7889689, -80.2264393 | Site | Miami | Florida | Recruiting |
Geolocation is 25.8223198, -80.289495 | Site | Miami Springs | Florida | Recruiting |
Geolocation is 29.1871986, -82.1400923 | Site | Ocala | Florida | Recruiting |
Geolocation is 28.5383355, -81.3792365 | Site | Orlando | Florida | Recruiting |
Geolocation is 26.8233946, -80.1386547 | Site | Palm Beach Gardens | Florida | Recruiting |
Geolocation is 26.1571743, -80.2862256 | Site | Sunrise | Florida | Recruiting |
Geolocation is 27.950575, -82.4571776 | Site | Tampa | Florida | Recruiting |
Geolocation is 33.7489954, -84.3879824 | Site | Atlanta | Georgia | Recruiting |
Geolocation is 32.4609764, -84.9877094 | Site | Columbus | Georgia | Recruiting |
Geolocation is 33.7748275, -84.2963123 | Site | Decatur | Georgia | Recruiting |
Geolocation is 42.0039178, -87.9703461 | Site | Elk Grove Village | Illinois | Recruiting |
Geolocation is 41.6819935, -85.9766671 | Site | Elkhart | Indiana | Recruiting |
Geolocation is 39.768403, -86.158068 | Site | Indianapolis | Indiana | Recruiting |
Geolocation is 42.3370413, -71.2092214 | Site | Newton | Massachusetts | Recruiting |
Geolocation is 42.4828221, -83.4183823 | Site | Farmington Hills | Michigan | Recruiting |
Geolocation is 42.5678534, -83.373339 | Site | West Bloomfield | Michigan | Recruiting |
Geolocation is 40.2962222, -74.0509725 | Site | Eatontown | New Jersey | Recruiting |
Geolocation is 39.9537358, -74.1979458 | Site | Toms River | New Jersey | Recruiting |
Geolocation is 42.6525793, -73.7562317 | Site | Albany | New York | Recruiting |
Geolocation is 42.9756133, -78.7914222 | Site | Amherst | New York | Recruiting |
Geolocation is 42.7470225, -73.7590088 | Site | Latham | New York | Recruiting |
Geolocation is 43.16103, -77.6109219 | Site | Rochester | New York | Recruiting |
Geolocation is 39.6283928, -84.1593818 | Site | Centerville | Ohio | Recruiting |
Geolocation is 35.4675602, -97.5164276 | Site | Oklahoma City | Oklahoma | Recruiting |
Geolocation is 45.5234515, -122.6762071 | Site | Portland | Oregon | Recruiting |
Geolocation is 40.1198332, -75.1253492 | Site | Abington | Pennsylvania | Recruiting |
Geolocation is 40.0959438, -75.1251743 | Site | Jenkintown | Pennsylvania | Recruiting |
Geolocation is 41.8137116, -71.3700545 | Site | East Providence | Rhode Island | Recruiting |
Geolocation is 35.9606384, -83.9207392 | Site | Knoxville | Tennessee | Recruiting |
Geolocation is 30.267153, -97.7430608 | Site | Austin | Texas | Recruiting |
Geolocation is 32.7801399, -96.8004511 | Site | Dallas | Texas | Recruiting |
Geolocation is 29.7601927, -95.3693896 | Site | Houston | Texas | Recruiting |
Geolocation is 29.4241219, -98.4936282 | Site | San Antonio | Texas | Recruiting |
Geolocation is 42.878094, -73.1968001 | Site | Bennington | Vermont | Recruiting |
Geolocation is 37.5407246, -77.4360481 | Site | Richmond | Virginia | Recruiting |
Geolocation is 43.0389025, -87.9064736 | Site | Milwaukee | Wisconsin | Recruiting |
Lead Sponsor:
| Agency |
|---|
Eisai Inc. |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Chad Swanson | Study Director | Eisai Inc. |
Study Contact:
| Name | Phone |
|---|---|
Eisai Medical Services | 888-422-4743 |
Locations
ClinicalTrials.gov ID
NCT01767311 (follow link to view full record on ct.gov in new window)
Official Title:
A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer?s Disease
Study Start Date:
December 2012
Study End Date:
April 2016
Disease Stage:
Early
Enrollment:
800
