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.

Lead Sponsor:

Biogen

Intervention(s):

  • Drug: BIIB037
  • Other: Placebo

Phase:

Phase 1

Eligibility


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.

Ages Eligible for Study

55 Years - 85 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christina Wyss-Coray
650-721-2409
Recruiting