Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease
NCT ID: NCT01677572
Last Updated: 2020-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
197 participants
INTERVENTIONAL
2012-10-05
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low-dose #1 Aducanumab
Intravenous doses of low-dose level #1 Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study 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 and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Low-dose #2 Aducanumab
Intravenous doses of low-dose level #2 Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study 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 and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Placebo (low dose group)
Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses.
Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study 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 and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Placebo
Placebo to mimic the low dose, mid-dose and high-dose treatment arms of the experimental intervention; administered by intravenous (IV) infusion on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Mid-dose Aducanumab
Intravenous doses of mid-dose Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study 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 and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Placebo (mid dose group)
Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study 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 and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Placebo
Placebo to mimic the low dose, mid-dose and high-dose treatment arms of the experimental intervention; administered by intravenous (IV) infusion on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
High-dose Aducanumab
Intravenous doses of high-dose Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study 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 and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Placebo (high dose group)
Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose administered approximately 4 weeks apart for up to an additional 112 doses.
Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study 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 and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Placebo
Placebo to mimic the low dose, mid-dose and high-dose treatment arms of the experimental intervention; administered by intravenous (IV) infusion on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Aducanumab Titration
Intravenous doses of Aducanumab administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses.
Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study 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 and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Placebo (Titration Group)
Intravenous doses of placebo administered approximately 4 weeks apart over approximately 52 weeks (a total of 14 doses). Qualifying participants can continue into the long-term extension at a dose approximately 4 weeks apart for up to an additional 112 doses.
Placebo
Placebo to mimic the low dose, mid-dose and high-dose treatment arms of the experimental intervention; administered by intravenous (IV) infusion on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Interventions
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Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study 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 and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Placebo
Placebo to mimic the low dose, mid-dose and high-dose treatment arms of the experimental intervention; administered by intravenous (IV) infusion on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
50 Years
90 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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NNS Clinical Research, LLC
Tucson, Arizona, United States
Senior Clinical Trials, Inc.
Laguna Hills, California, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, United States
Collaborative Neuroscience Network, LLC
Long Beach, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Pacific Neuroscience Medical Group
Oxnard, California, United States
Pacific Research Network, Inc.
San Diego, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Alzheimer's Disease Research Unit, Yale University
New Haven, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
MD Clinical Trials, Inc.
Hallandale, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Galiz Research, LLC
Miami Springs, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Infinity Clinical Research, Inc.
Sunrise, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
Neurostudies.net, LLC
Decatur, Georgia, United States
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
St. Louis Clinical Trials, LLC
St Louis, Missouri, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
CRI Lifetree
Marlton, New Jersey, United States
Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States
Empire Neurology, PC
Latham, New York, United States
Insight Clinical Trials LLC
Beachwood, Ohio, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Brown Hospital
East Providence, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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References
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Chen T, O'Gorman J, Castrillo-Viguera C, Rajagovindan R, Curiale GG, Tian Y, Patel D, von Rosenstiel P, von Hehn C, Salloway S, Hock C, Nitsch RM, Haeberlein SB, Sandrock A, Singhal P. Results from the long-term extension of PRIME: A randomized Phase 1b trial of aducanumab. Alzheimers Dement. 2024 May;20(5):3406-3415. doi: 10.1002/alz.13755. Epub 2024 Apr 3.
Sevigny J, Chiao P, Bussiere T, Weinreb PH, Williams L, Maier M, Dunstan R, Salloway S, Chen T, Ling Y, O'Gorman J, Qian F, Arastu M, Li M, Chollate S, Brennan MS, Quintero-Monzon O, Scannevin RH, Arnold HM, Engber T, Rhodes K, Ferrero J, Hang Y, Mikulskis A, Grimm J, Hock C, Nitsch RM, Sandrock A. The antibody aducanumab reduces Abeta plaques in Alzheimer's disease. Nature. 2016 Sep 1;537(7618):50-6. doi: 10.1038/nature19323.
Other Identifiers
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2012-000349-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
221AD103
Identifier Type: -
Identifier Source: org_study_id
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