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

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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
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Latham, New York 12110
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Los Angeles, California 90095
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
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3212 Cove Bend Drive
Tampa, Florida 33613
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3570 Warrensville Center Road
Beachwood, Ohio 44122
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Decatur, Georgia 30033
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Delray Beach, Florida 33445
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164 Summit Avenue
East Providence, Rhode Island 02906
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Eatontown, New Jersey 07724
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Elk Grove Village, Illinois 60007
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911 East Hallandale Beach Boulevard
Hallandale Beach, Florida 33009
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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...
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Laguna Hills, California 92653
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Long Beach, California 90806
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Marlton, New Jersey 08053
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Miami, Florida 33137
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Miami Springs, Florida 33166
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Portland, Oregon 97210
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Saint Louis, Missouri 63141
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San Diego, California 92103
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San Francisco, California
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
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Sunrise, Florida 33351
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Toms River, New Jersey 08757
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Tucson, Arizona 85741
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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...
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