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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01677572
First received: August 30, 2012
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

The primary objective of this study is to evaluate the safety and tolerability of multiple doses of BIIB037 (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 BIIB037 and to evaluate the immunogenicity of BIIB037 after multiple dose administration in this population.


Condition Intervention Phase
Alzheimer's Disease
Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Baseline to week 126 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in florbetapir-fluorine-18 (18F-AV-45F-AV-45) positron emission tomography (PET) imaging in certain brain areas. [ Time Frame: Day 1 (baseline), Weeks 26, 54 and Week 70 (18 weeks after the final dose) ] [ Designated as safety issue: No ]
  • Multiple dose pharmacokinetic (PK) serum concentrations of BIIB037 [ Time Frame: Up to Weeks 52, 57, 85 and 113. ] [ Designated as safety issue: No ]
  • Change from Baseline in Incidence of Anti-BIIB037 Antibodies in Serum. [ Time Frame: Baseline to week 70 ] [ Designated as safety issue: No ]

Estimated Enrollment: 194
Study Start Date: October 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-dose #1 BIIB037
Intravenous doses of low-dose level #1 BIIB037 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 an additional 14 doses.
Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of BIIB037 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 14 additional doses.
Other Names:
  • IgG1
  • anti-A* mAb
  • Fully human
Experimental: Low-dose #2 BIIB037
Intravenous doses of low-dose level #2 BIIB037 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 an additional 14 doses.
Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of BIIB037 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 14 additional doses.
Other Names:
  • IgG1
  • anti-A* mAb
  • Fully human
Placebo Comparator: 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 additional 14 doses.
Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of BIIB037 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 14 additional doses.
Other Names:
  • IgG1
  • anti-A* mAb
  • Fully human
Drug: 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 BiIB037 doses for up to 14 additional doses.
Experimental: Mid-dose BIIB037
Intravenous doses of mid-dose BIIB037 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 an additional 14 doses.
Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of BIIB037 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 14 additional doses.
Other Names:
  • IgG1
  • anti-A* mAb
  • Fully human
Placebo Comparator: 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 additional 14 doses.
Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of BIIB037 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 14 additional doses.
Other Names:
  • IgG1
  • anti-A* mAb
  • Fully human
Drug: 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 BiIB037 doses for up to 14 additional doses.
Experimental: High-dose BiiB037
Intravenous doses of high-dose BIIB037 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 an additional 14 doses.
Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of BIIB037 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 14 additional doses.
Other Names:
  • IgG1
  • anti-A* mAb
  • Fully human
Placebo Comparator: 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 additional 14 doses.
Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of BIIB037 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 14 additional doses.
Other Names:
  • IgG1
  • anti-A* mAb
  • Fully human
Drug: 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 BiIB037 doses for up to 14 additional doses.

Detailed Description:

The study consists of a placebo-controlled period to study week 54, followed by a long-term extension to study week 126. 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 14 additional doses of active drug.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Subjects must meet criteria for Prodromal Alzheimer's Disease (AD) or Mild Alzheimer's Disease (AD):

    1. Mini Mental State Examination (MMSE) score between 20-30,
    2. Clinical Dementia Rating Scale (CDR) score of 0.5 or 1.0.
    3. A free recall score of lesser or equal to 27 on the Free and Cued Selective Reminding Test (FCSRT) for prodromal Alzheimer's Disease (AD).
  • Subjects must have a positive florbetapir positron emission tomography (PET) amyloid scan.
  • Subjects must consent to apolipoprotein E (ApoE) genotyping.
  • Apart from clinical diagnosis of Alzheimer's Disease (AD), subject 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 subject'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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677572

Contacts
Contact: Biogen Idec clinicaltrials@biogenidec.com

  Show 37 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01677572     History of Changes
Other Study ID Numbers: 221AD103, EUDRA CT #: 2012-000349-10
Study First Received: August 30, 2012
Last Updated: August 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014