Skip Navigation

Advertise|Press|Contact|FAQ|CWConnect

Bookmark/Print/Share

Home » Clinical Trials » Alzheimer's Disease

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 purpose of this study is to evaluate the safety and tolerability of multiple doses of BIIB037 administered via intravenous (IV) infusions in subjects with prodromal or mild Alzheimer's Disease (AD). Patients who meet the inclusion criteria will be eligible for a dose-blinded long-term extension (LTE), following the double-blinded placebo-controlled portion, with all subjects receiving BIIB037.

To Learn more
Phase

1

Gender

Both Male and Female

Age

50 to 90 Years

Overall Status

Recruiting

Lead Sponsor

Biogen Idec

Duration

25 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 50 Years to 90 Years

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, and

  • 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.

Inclusion Criteria for the Long Term Extension (LTE), candidates must meet the following eligibility criteria at Week 56:

  1. Subject must have completed the placebo-controlled portion of the study. Subject must have received 11 or more doses, and must not have missed more than 2 consecutive doses; subjects who don't meet this criteria can only enter the Long Term Extension (LTE) upon Sponsor's approval.

  2. Mini Mental State Examination (MMSE) score > 10 at the Week 54 visit.

  3. Subject (or subject's legal representative) 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.

  4. Must be ambulatory.

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 psychatric 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.

Exclusion Criteria for Long-term Extension:

Any medical or psychiatric contraindication or clinically significant abnormality that, in opinion of the Investigator, will substantially increase the risk associated with the subject's participation in and completion of the study.

Site Locations (12)

Country State City Zip Facility and Contact
United States Arizona Tucson Research Site
United States California San Francisco Research Site
United States Florida Delray Beach Research Site
United States Florida Fort Myers Research Site
United States Florida Hallendale Beach Research Site
United States Florida Orlando Research Site
United States Florida Tampa Research Site
United States Missouri St. Louis Research Site
United States New Jersey Eatontown Research Site
United States New Jersey Toms River Research Site
United States Ohio Beechwood Research Site
United States Ohio Toledo Research Site

Contact

Medical Director

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

Name:
Address:
City:
State:
Zip/Postal Code:
Country:
Phone:
Email:  
Message:
 
Please leave this field empty.

NCT ID: NCT01677572

Date Last Changed: September 12, 2013

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials. Some study summaries have been edited for clarity purposes to make them easier to understand. View more study details here.