CompletedPhase 1

Single Ascending Dose Study of BIIB037 in Participants 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

Lead sponsor

Biogen

Asset

Aducanumab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 14-26•MRI contraindications excluded

Primary endpoint

•Adverse Events as a Measure of Safety and Tolerability

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID221AD101

NCT IDNCT01397539

Timeline

Milestones

Study start2011-06 (month precision)

Study first posted2011-07-19estimated

Primary completion2013-08actual (month precision)

Study completion2013-08actual (month precision)

Last update posted2015-03-23estimated

Assets

Drug assets

Aducanumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Neuroimaging

1 endpoint

Primary/protocol endpoint

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

Time frame:6 months

event count, event

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Maximum Concentration [Cmax] of BIIB037

Time frame:6 Months

concentration, descriptive

Secondary/protocol endpoint

Time to Cmax [Tmax]

Time frame:6 Months

time to event, event

Secondary/protocol endpoint

Elimination Half-life [t1/2]

Time frame:6 Months

concentration, descriptive

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

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

Time frame:6 months

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:6 months

concentration, descriptive

Secondary/protocol endpoint/low confidence

Clearance [Cl]

Time frame:6 Months

descriptive

Secondary/protocol endpoint/low confidence

Incidence of Anti-BIIB037 Antibodies in Serum

Time frame:6 Months

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID29067304via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.