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

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BIIB037

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Brain Matters Research
Compass Research, LLC
Insight Clinical Trials, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BIIB037

Placebo

Arm Description

A single dose of BIIB037 by intravenous infusion.

A single dose of placebo matching BIIB037 by intravenous infusion.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Area Under the Curve from Time Zero Extrapolated to Infinity [AUC0-∞]

Area Under the Curve from Time 0 to Time of the Last Measurable Concentration [AUC0-tlast]

Maximum Concentration [Cmax] of BIIB037

Time to Cmax [Tmax]

Elimination Half-life [t1/2]

Clearance [Cl]

Incidence of Anti-BIIB037 Antibodies in Serum

Full Information

NCT ID

NCT01397539

First Posted

June 30, 2011

Last Updated

March 19, 2015

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT01397539

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIIB037

Arm Type

Experimental

Arm Description

A single dose of BIIB037 by intravenous infusion.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

A single dose of placebo matching BIIB037 by intravenous infusion.

Intervention Type

Drug

Intervention Name(s)

BIIB037

Other Intervention Name(s)

Aducanumab, fully human IgG1 anti-Aβ mAb

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Area Under the Curve from Time Zero Extrapolated to Infinity [AUC0-∞]

Time Frame

6 months

Title

Area Under the Curve from Time 0 to Time of the Last Measurable Concentration [AUC0-tlast]

Time Frame

6 months

Title

Maximum Concentration [Cmax] of BIIB037

Time Frame

6 Months

Title

Time to Cmax [Tmax]

Time Frame

6 Months

Title

Elimination Half-life [t1/2]

Time Frame

6 Months

Title

Clearance [Cl]

Time Frame

6 Months

Title

Incidence of Anti-BIIB037 Antibodies in Serum

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Brain Matters Research

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Facility Name

Compass Research, LLC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Insight Clinical Trials, LLC

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29067304

Citation

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.

Results Reference

derived

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

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