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

NCT01397539 | Completed Phase 1 DMC

• 1 other identifier: 221AD101
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  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).

  6 months

Secondary Outcomes (7)

• 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

• Maximum Concentration [Cmax] of BIIB037

  6 Months

• Time to Cmax [Tmax]

  6 Months

• Elimination Half-life [t1/2]

  6 Months

Study Arms (2)

BIIB037

EXPERIMENTAL

A single dose of BIIB037 by intravenous infusion.

Drug: BIIB037

Placebo

PLACEBO COMPARATOR

A single dose of placebo matching BIIB037 by intravenous infusion.

Other: Placebo

Interventions

BIIB037 DRUG

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.

Also known as: Aducanumab, fully human IgG1 anti-Aβ mAb

BIIB037

Placebo OTHER

Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion.

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be ambulatory
• Must have a clinical diagnosis of Alzheimer's Disease (AD) consistent with the following:
• 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 \[McKhann et al. 1984\].
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Biogen: lead

Study Sites (3)

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Insight Clinical Trials, LLC

Beachwood, Ohio, 44122, United States

Location

Related Publications (1)

• Ferrero J, Williams L, Stella H, Leitermann K, Mikulskis A, O'Gorman J, Sevigny J. First-in-human, double-blind, placebo-controlled, single-dose escalation study of aducanumab (BIIB037) in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2016 Jun 20;2(3):169-176. doi: 10.1016/j.trci.2016.06.002. eCollection 2016 Sep.

  PMID: 29067304 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

aducanumab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 19, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 23, 2015

Record last verified: 2015-03

Locations

US (3)