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Clinical Trial Details

Overview

Research Study Summary

A clinical trial to evaluate treatments using BIIB037 and Placebo for patients with Alzheimer's Disease

Research Study Title

A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease

Purpose

The primary objective of this study is to evaluate the safety and tolerability of multiple doses of BIIB037 (recombinant, fully human anti-Aβ IgG1 mAb) in participants with prodromal or mild Alzheimer's Disease (AD). The secondary objectives of this study are to assess the effect on cerebral amyloid plaque content as measured by florbetapir-fluorine-18 (18F-AV-45F-AV-45) positron emission tomography (PET) imaging, to assess the multiple dose serum concentrations of BIIB037 and to evaluate the immunogenicity of BIIB037 after multiple dose administration in this population.

To Learn more
Phase

1

Gender

Both Male and Female

Age

50 to 90 Years

Overall Status

Recruiting

Lead Sponsor

Biogen Idec

Duration

43 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 50 Years to 90 Years

Key Inclusion Criteria:

  • Subjects must meet criteria for Prodromal Alzheimer's Disease (AD) or Mild Alzheimer's Disease (AD):

  • Mini Mental State Examination (MMSE) score between 20-30,

  • Clinical Dementia Rating Scale (CDR) score of 0.5 or 1.0.

  • A free recall score of lesser or equal to 27 on the Free and Cued Selective Reminding Test (FCSRT) for prodromal Alzheimer's Disease (AD).

  • Subjects must have a positive florbetapir positron emission tomography (PET) amyloid scan.

  • Subjects must consent to apolipoprotein E (ApoE) genotyping.

  • Apart from clinical diagnosis of Alzheimer's Disease (AD), subject must be in good health.

  • Must have a reliable informant or caregiver.

Key Exclusion Criteria:

  • Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment.

  • Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year.

  • Clinically significant psychiatric illness in past 6 months.

  • Seizure in the past 3 years.

  • Poorly controlled diabetes mellitus.

  • History of unstable angina, myocardial infarction, chronic heart failure, or clinical significant conduction abnormalities within 1 year prior to Screening.

  • Indication of impaired renal or liver function.

  • Have human immunodeficiency virus (HIV) infection.

  • Have a significant systematic illness or infection in past 30 days.

  • Brain MRI showing evidence of acute or sub-acute micro or macrohemorrhage, greater than 4 microhemorrhages, cortical infarct or greater than one 1 lunar infarct.

  • Any contraindications to brain MRI or positron emission tomography (PET) scans.

  • Negative positron emission tomography (PET) scan with any amyloid-targeting ligand within 48 weeks of Screening.

  • Clinically significant 12-lead electrocardiogram (ECG) abnormalities.

  • Alcohol or substance abuse in past 1 year.

  • Taking blood thinners (except for aspirin at a prophylactic dose or less)

  • Have changes in medications or doses of medication in past 4 weeks.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Site Locations (30)

Country State City Zip Facility and Contact
United States Arizona Tuscon 85741 Northwest NeuroSpecialists, PLLC
United States California Laguna Hills 92653 Senior Clinical Trials, Inc.
United States California Lomita 90717 Torrance Clinical Research Institute, Inc.
United States California Long Beach 90806 Collaborative Neuroscience Network, Inc.
Marianne M. de Visser
31 20 566 4026
m.devisser@amc.uva.nl

Marianne M. de Visser
Principal Investigator
United States California Los Angeles 90095 University of California, Los Angeles
United States California Oxnard 93030 Pacific Neuroscience Medical Group
United States California San Diego 92013 Pacific Research Network, Inc.
United States California San Francisco 94109 San Francisco Clinical Research Center
United States California Standford 94305 Stanford University Medical Center
United States Connecticut New Haven 6519 Alzheimer's Disease Research Unit, Yale University
United States Connecticut New Haven 6510 Institute For Neurodegenerative Disorders
United States District of Columbia Washington 20057 Georgetown University Hospital
United States Florida Delray Beach 33445 Brain Matters Research
United States Florida Fort Meyers 33912 Neuropsychiatric Research Center of Southwest Florida
United States Florida Hallandale Beach 33009 MD Clinical
United States Florida Miami 33137 Miami Jewish Health Systems
United States Florida Orlando 32806 Compass Research, LLC
United States Florida Sunrise 33351 Neurology Clinical Research, Inc.
United States Florida Tampa 33609 Axiom Clinical Research of Florida
United States Florida Tampa 33613 Stedman Clinical Trials, LLC
United States Georgia Decatur 30033 Neurostudies.net, LLC
United States Illinois Elk Grove Village 60007 Alexian Brothers Neuroscience Institute
United States Indiana Indianapolis 46202 Indiana University School of Medicine
United States Missouri St. Louis 63118 St. Louis Clinical Trials, LLC
United States New Jersey Tom's River 8755 Memory Enhancement Center of NJ
United States New York Latham 12110 Empire Neurology, PC
United States Ohio Beachwood 44122 Insight Clinical Trials, LLC
United States Oregon Portland 97210 Summit Research Network (Oregon) Inc.
United States Rhode Island East Providence 2906 Butler Hospital
United States Rhode Island Providence 2903 Rhode Island Hospital

Contact

Biogen Idec

E-mail:

NCT ID: NCT01677572

Date Last Changed: August 29, 2014

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