Trial record 2 of 2 for:    BIIB037

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01397539
First received: June 30, 2011
Last updated: September 20, 2012
Last verified: September 2012

June 30, 2011
September 20, 2012
June 2011
February 2013   (final data collection date for primary outcome measure)
Safety as measured by adverse event monitoring, laboratory assessments and MRI Tolerability as measured by adverse event monitoring, laboratory assessments and MRI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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
  • evaluate the PK of BIIB037 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • evaluate the immunogenicity of BIIB037 after single dose administration [ 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 Subjects 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 purpose of the study is to evaluate the safety and tolerability of a range of BIIB037 doses administered as single intravenous (IV) infusions in subjects with AD.

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 of Aß. In animal models of Alzheimer's disease, treatment with BIIB037 was shown to decrease beta amyloid content in animal brain. The study will be conducted in subjects with mild to moderate AD to profile the safety, tolerability, and pharmacokinetics (PK) of single doses of BIIB037 in the presence of the biological target (i.e., Aß plaques).

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
    Subjects will receive a single dose of BIIB037 IV
  • Other: Placebo
    IV
  • Experimental: BIIB037
    Intervention: Drug: BIIB037
  • Placebo Comparator: Placebo
    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.
 
Active, not recruiting
48
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men or women aged 55 to 85 years old, inclusive, at the time of informed consent
  • Must be ambulatory
  • Must have a clinical diagnosis of AD consistent with the following:

    1. Probable 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.

Exclusion Criteria:

  • Any medical or neurological condition (other than 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 MRI (e.g., pacemaker; non MRI-compatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia).
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01397539
221AD101
Yes
Biogen Idec Medical Director, Biogen Idec Inc
Biogen Idec
Not Provided
Not Provided
Biogen Idec
September 2012

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