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Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01397539
First received: June 30, 2011
Last updated: September 12, 2014
Last verified: September 2014

June 30, 2011
September 12, 2014
June 2011
August 2013   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Significant assessments reported as AEs or SAEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead electrocardiogram (ECG), and brain MRI findings (including the occurrence of vasogenic edema and incident hemorrhage).
  • clinical laboratory assessments [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • nature of adverse events (AEs) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • serious adverse events (SAEs) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • vital signs [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • brain magnetic resonance imaging (MRI) findings (including the occurrence of vasogenic edema and incident hemorrhage). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • neurological examination [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01397539 on ClinicalTrials.gov Archive Site
  • Area Under the Curve from Time Zero Extrapolated to Infinity [AUC0-∞] [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Area Under the Curve from Time 0 to Time of the Last Measurable Concentration [AUC0-tlast] [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Maximum Concentration [Cmax] of BIIB037 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Time to Cmax [Tmax] [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Elimination Half-life [t1/2] [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Clearance [Cl] [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Incidence of Anti-BIIB037 Antibodies in Serum [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
serum BIIB037 concentrations and PK parameters (including AUC0-∞, AUC0 tlast, maximum concentration [Cmax], time to Cmax [Tmax], elimination half-life [t1/2], and Cl); and incidence of anti-BIIB037 antibodies in serum. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease
A Randomized, Blinded, Placebo-Controlled Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB037 in Subjects With Mild to Moderate Alzheimer's Disease

The primary objective of the study is to evaluate the safety and tolerability of a range of BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study population are to assess the pharmacokinetics(PK) and to evaluate the immunogenicity of BIIB037 after single-dose administration.

BIIB037 is an investigational product being developed as a treatment for Alzheimer's disease (AD). BIIB037 is a fully human immunoglobulin gamma 1 (IgG1) monoclonal antibody that is selective for the fibrillar form of beta amyloid (Aß).

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: BIIB037
    Participants receive a single dose of BIIB037 by intravenous (IV) infusion in cohorts assigned to the following ascending doses: .03 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg, and 60 mg/kg.
    Other Name: fully human IgG1 anti-Aβ mAb
  • Other: Placebo
    Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion.
  • Experimental: BIIB037
    A single dose of BIIB037 by intravenous infusion.
    Intervention: Drug: BIIB037
  • Placebo Comparator: Placebo
    A single dose of placebo matching BIIB037 by intravenous infusion.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
August 2013
August 2013   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Must be ambulatory
  • Must have a clinical diagnosis of Alzheimer's Disease (AD) consistent with the following:

    1. Probable Alzheimer's Disease (AD), according to National Institute of Neurological and Communicative Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria [McKhann et al. 1984].
    2. Dementia of Alzheimer's type, according to Diagnostic and Statistical Manual of Mental Disorders-Text Revision (DSM IV TR) criteria [American Psychiatric Association 2000]
  • Subject (or subject's permanent caregiver) 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.
  • Must have a Mini Mental State Examination (MMSE) score of 14 to 26 inclusive.

Key Exclusion Criteria:

  • Any medical or neurological condition other than Alzheimer's Disease (AD) that in the opinion of the Investigator could be a contributing cause of the subject's dementia (e.g., medication use, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, diffuse Lewy body disease, head trauma).
  • History within the past 6 months or evidence of clinically significant psychiatric illness (e.g., major depression, schizophrenia, or bipolar affective disorder).
  • Subject currently lives in a nursing home.
  • Blood donation (1 unit or more) within the 1 month prior to Screening
  • Participation in any other drug, biologic, device, or clinical study or treatment with any investigational drug or approved therapy for investigational use within 30 days (or 5 half lives, whichever is longer) prior to Screening, and/or participation in any other clinical study involving experimental medications for AD within the 60 days (or 5 half lives, whichever is longer) prior to Screening.
  • Any contraindications to having a brain Magnetic Resonance Imaging (MRI) e.g., pacemaker; Non-Magnetic Resonance Imaging (MRI)-compatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01397539
221AD101
Yes
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
September 2014

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