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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: BIIB037
Other: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: June 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB037
A single dose of BIIB037 by intravenous infusion.
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
Placebo Comparator: Placebo
A single dose of placebo matching BIIB037 by intravenous infusion.
Other: Placebo
Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT01397539

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

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01397539     History of Changes
Other Study ID Numbers: 221AD101
Study First Received: June 30, 2011
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014