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

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 of Aß. In animal models of Alzheimer's disease, treatment with
BIIB037 was shown to decrease beta amyloid content in animal brain. The study will be
conducted in subjects with mild to moderate AD to profile the safety, tolerability, and
pharmacokinetics (PK) of single doses of BIIB037 in the presence of the biological target
(i.e., Aß plaques).

Inclusion Criteria:

- Men or women aged 55 to 85 years old, inclusive, at the time of informed consent

- Must be ambulatory

- Must have a clinical diagnosis of AD consistent with the following:

1. Probable 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 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 MRI (e.g., pacemaker; non MRI-compatible
aneurysm clips, artificial heart valves, or other metal foreign body;
claustrophobia).