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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

August 30, 2012
August 29, 2014
October 2012
May 2016   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events [ Time Frame: Baseline to week 126 ] [ Designated as safety issue: Yes ]
Safety and tolerability as measured by adverse event monitoring, laboratory assessments, vital signs, neurological and physical exams, 12-lead ECG data, and brain MRI findings including the incidence of ARIA-E or ARIA-H [ Time Frame: Baseline to week 30 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01677572 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Assess the effect of BIIB037 on cerebral amyloid plaque as measured by PET imaging [ Time Frame: Baseline to week 18 ] [ Designated as safety issue: Yes ]
  • Assess the multiple dose PK serum concentrations of BIIB037 [ Time Frame: Baseline to week 30 ] [ Designated as safety issue: Yes ]
  • Assess the immunogenecity of BIIB037 after multiple dose administration [ Time Frame: Baseline to week 30 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Multiple Dose Study of BIIB037 (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease
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 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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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: 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.
    Intervention: Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
  • 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.
    Intervention: Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
  • 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.
    Interventions:
    • Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
    • Drug: Placebo
  • 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.
    Intervention: Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
  • 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.
    Interventions:
    • Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
    • Drug: Placebo
  • 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.
    Intervention: Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
  • 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.
    Interventions:
    • Drug: BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb)
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
194
June 2017
May 2016   (final data collection date for primary outcome measure)

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.

Both
50 Years to 90 Years
No
Contact: Biogen Idec clinicaltrials@biogenidec.com
United States
 
NCT01677572
221AD103, EUDRA CT #: 2012-000349-10
Yes
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP