Trial Search Results
Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease
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.
Stanford is currently accepting patients for this trial.
- Drug: BIIB037
- Other: Placebo
Key Inclusion Criteria:
- Must be ambulatory
- Must have a clinical diagnosis of Alzheimer's Disease (AD) consistent with the
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
- 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.
Ages Eligible for Study
55 Years - 85 Years
Genders Eligible for Study