Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease



Status:Active, not recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 90
Updated:9/12/2018
Start Date:October 5, 2012
End Date:October 21, 2021

Use our guide to learn which trials are right for you!

A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease

The primary objective of this study is to evaluate the safety and tolerability of multiple
doses of Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb) in participants with
prodromal or mild Alzheimer's Disease (AD). The secondary objectives of this study are to
assess the effect on cerebral amyloid plaque content as measured by florbetapir-fluorine-18
(18F-AV-45F-AV-45) positron emission tomography (PET) imaging, to assess the multiple dose
serum concentrations of Aducanumab and to evaluate the immunogenicity of Aducanumab after
multiple dose administration in this population.

The study consists of a placebo-controlled period to study week 54, followed by a long-term
extension to study week 518. The placebo-controlled period is conducted with a staggered,
parallel group design, with the first 3 treatment arms conducted in parallel, 2 further
treatment arms subsequently beginning in parallel, 2 additional treatment arms beginning in
parallel, and the last 2 treatment arms subsequently beginning in parallel. Qualifying
participants can enter the long-term extension period for up to 42 additional doses of active
drug for the first 3 years of LTE. Furthermore, up until the last participant in Arms 8 and 9
has had his or her last dose in the fifth year of the LTE, eligible participants will be able
to continue treatment beyond the third year of the LTE.

Key Inclusion Criteria:

- Participants must be ambulatory.

- Participants must meet the following core clinical criteria as determined by the
Investigator:

Prodromal Alzheimer's Disease (AD) (all of the criteria must apply):

- Mini Mental State Examination (MMSE) scores between 24-30 (inclusive)

- a spontaneous memory complaint

- objective memory loss defined as a free recall score of ≤27 on the Free and Cued
Selective Reminding Test (FCSRT)

- a global Clinical Dementia Rating Scale (CDR) score of 0.5

- absence of significant levels of impairment in other cognitive domains

- essentially preserved activities of daily living, and an absence of dementia. OR

Mild Alzheimer's Disease (AD) criteria (all criteria must apply):

- Mini Mental State Examination (MMSE) scores between 20-26 (inclusive)

- a global Clinical Dementia Rating Scale (CDR) of 0.5 or 1.0

- meeting the National Institute on Aging-Alzheimer's Association core clinical criteria
for probable AD.

- Participants must have a positive florbetapir positron emission tomography (PET)
amyloid scan.

- Participants must consent to apolipoprotein E (ApoE) genotyping.

- Apart from clinical diagnosis of Alzheimer's Disease (AD), participant must be in good
health.

- Must have a reliable informant or caregiver.

Key Exclusion Criteria:

- Any medical or neurological condition (other than Alzheimer's Disease) that might be a
contributing cause of the participant's cognitive impairment.

- Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of
consciousness in the past 1 year.

- Clinically significant psychiatric illness in past 6 months.

- Seizure in the past 3 years.

- Poorly controlled diabetes mellitus.

- History of unstable angina, myocardial infarction, chronic heart failure, or clinical
significant conduction abnormalities within 1 year prior to Screening.

- Indication of impaired renal or liver function.

- Have human immunodeficiency virus (HIV) infection.

- Have a significant systematic illness or infection in past 30 days.

- Brain MRI showing evidence of acute or sub-acute micro or macrohemorrhage, greater
than 4 microhemorrhages, cortical infarct or greater than one 1 lunar infarct.

- Any contraindications to brain MRI or positron emission tomography (PET) scans.

- Negative positron emission tomography (PET) scan with any amyloid-targeting ligand
within 48 weeks of Screening.

- Clinically significant 12-lead electrocardiogram (ECG) abnormalities.

- Alcohol or substance abuse in past 1 year.

- Taking blood thinners (except for aspirin at a prophylactic dose or less)

- Have changes in medications or doses of medication in past 4 weeks.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
32
sites
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
3212 Cove Bend Drive
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
3570 Warrensville Center Road
Beachwood, Ohio 44122
?
mi
from
Beachwood, OH
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Delray Beach, Florida 33445
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
164 Summit Avenue
East Providence, Rhode Island 02906
?
mi
from
East Providence, RI
Click here to add this to my saved trials
Eatontown, New Jersey 07724
?
mi
from
Eatontown, NJ
Click here to add this to my saved trials
Elk Grove Village, Illinois 60007
?
mi
from
Elk Grove Village, IL
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
911 East Hallandale Beach Boulevard
Hallandale Beach, Florida 33009
?
mi
from
Hallandale Beach, FL
Click here to add this to my saved trials
340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Laguna Hills, California 92653
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
Latham, New York 12110
?
mi
from
Latham, NY
Click here to add this to my saved trials
?
mi
from
Lomita, CA
Click here to add this to my saved trials
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Marlton, New Jersey 08053
?
mi
from
Marlton, NJ
Click here to add this to my saved trials
Miami, Florida 33137
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Springs, Florida 33166
?
mi
from
Miami Springs, FL
Click here to add this to my saved trials
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
Oxnard, CA
Click here to add this to my saved trials
Portland, Oregon 97210
?
mi
from
Portland, OR
Click here to add this to my saved trials
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Sunrise, Florida 33351
?
mi
from
Sunrise, FL
Click here to add this to my saved trials
Toms River, New Jersey 08757
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
Tucson, Arizona 85741
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
?
mi
from
Washington,
Click here to add this to my saved trials