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

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: BIIB037; Other: Placebo

• Registration Number: NCT01397539
• Lead Sponsor: Biogen

Brief Summary

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.

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).

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-30
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIIB037	BIIB037	A single dose of BIIB037 by intravenous infusion.
Placebo	Placebo	A single dose of placebo matching BIIB037 by intravenous infusion.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	6 months	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

Name	Time	Method
Area Under the Curve from Time Zero Extrapolated to Infinity [AUC0-∞]	6 months
Area Under the Curve from Time 0 to Time of the Last Measurable Concentration [AUC0-tlast]	6 months
Time to Cmax [Tmax]	6 Months
Clearance [Cl]	6 Months
Elimination Half-life [t1/2]	6 Months
Maximum Concentration [Cmax] of BIIB037	6 Months
Incidence of Anti-BIIB037 Antibodies in Serum	6 Months

Trial Locations

Locations (3)

Compass Research, LLC; 🇺🇸 Orlando, Florida, United States

Brain Matters Research; 🇺🇸 Delray Beach, Florida, United States

Insight Clinical Trials, LLC; 🇺🇸 Beachwood, Ohio, United States