Trial record 1 of 2 for:    BIIB037
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Multiple Dose Study of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease.

This study is currently recruiting participants.
Verified April 2013 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01677572
First received: August 30, 2012
Last updated: September 12, 2013
Last verified: April 2013

August 30, 2012
September 12, 2013
October 2012
November 2014   (final data collection date for primary outcome measure)
Safety and tolerability as measured by adverse event monitoring and brain magnetic resonance imaging findings including the incidence of amyloid-related imaging abnormality-edema and amyloid-related imaging abnormality-hemorrhage. [ 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 as measured by 18F-AV-45 PET scan [ Time Frame: at week 26 and week 54 ] [ Designated as safety issue: Yes ]
  • Multiple dose pharmacokinetic (PK) serum concentrations of BIIB037 [ Time Frame: up to week 52 ] [ Designated as safety issue: Yes ]
  • Immunogenecity of BIIB037 after multiple dose administration [ Time Frame: Baseline to week 70 ] [ Designated as safety issue: Yes ]
  • 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 in Subjects 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 purpose of this study is to evaluate the safety and tolerability of multiple doses of BIIB037 administered via intravenous (IV) infusions in subjects with prodromal or mild Alzheimer's Disease (AD). Patients who meet the inclusion criteria will be eligible for a dose-blinded long-term extension (LTE), following the double-blinded placebo-controlled portion, with all subjects receiving BIIB037.

BIIB037 is an investigational product being developed as a disease modification treatment for Alzheimer's disease (AD). BIIB037 is a fully human monoclonal antibody that recognizes amyloid plaques. In animal models of Alzheimer's disease, treatment with BIIB037 was shown to decrease beta amyloid content in animal brain. A single ascending dose study of BIIB037 in subjects with mild to moderate Alzheimer's Disease (AD) is ongoing. This study will be conducted in subjects with prodromal or mild Alzheimer's Disease (AD) to assess the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profile after multiple doses of BIIB037.

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
    Subjects will recevie multiple doses of BIIB037 intravenous (IV) infusion
  • Drug: Placebo
    intravenous (IV) infusion
  • Experimental: BIIB037
    Administered by intravenous (IV) infusion
    Intervention: Drug: BIIB037
  • Placebo Comparator: Placebo
    Administered by intravenous (IV) infusion
    Intervention: 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
160
April 2016
November 2014   (final data collection date for primary outcome measure)

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, and
    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.

Inclusion Criteria for the Long Term Extension (LTE), candidates must meet the following eligibility criteria at Week 56:

  1. Subject must have completed the placebo-controlled portion of the study. Subject must have received 11 or more doses, and must not have missed more than 2 consecutive doses; subjects who don't meet this criteria can only enter the Long Term Extension (LTE) upon Sponsor's approval.
  2. Mini Mental State Examination (MMSE) score >10 at the Week 54 visit.
  3. Subject (or subject's legal representative) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent (or assent) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  4. Must be ambulatory.

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 psychatric 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.

Exclusion Criteria for Long-term Extension:

Any medical or psychiatric contraindication or clinically significant abnormality that, in opinion of the Investigator, will substantially increase the risk associated with the subject's participation in and completion of the study.

Both
50 Years to 90 Years
No
Contact: Medical Director 221AD103@biogenidec.com
United States
 
NCT01677572
221AD103, EUDRA CT #: 2012-000349-10
Yes
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
April 2013

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