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E2609 for Mild Cognitive Impairment Due to Alzheimer's Disease

Start: November 2014
End: December 20, 2019
Enrollment: 700

What Is This Study About?

This study will evaluate the safety and efficacy of the experimental drug E2609, a BACE inhibitor, in people with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 85 Years

Must have:

  • MCI or mild dementia due to Alzheimer's disease according to criteria of the National Institute on Aging-Alzheimer's Association
  • Amyloid-positive positron emission tomography (PET) image
  • Caregiver or informant who is willing and able to provide follow-up information on the participant throughout the study 
  • If taking an Alzheimer's medication (acetylcholinesterase inhibitor or memantine), must have been on a stable dose for at least 12 weeks, with no expected change in dose
  • On stable doses of all other permitted, long-term medications for at least 4 weeks

Must NOT have:

  • Any neurological condition besides Alzheimer's that may contribute to cognitive impairment, for example, cerebrovascular disease
  • History of transient ischemic attacks or stroke within 12 months of screening
  • History of epilepsy
  • Evidence of depression or other psychiatric diagnosis or symptoms at screening (for example, hallucinations, suicidal ideation or behavior)
  • Abnormally low level of serum vitamin B12
  • Above-normal level of thyroid-stimulating hormone
  • Liver disease
  • Inability to undergo MRI and PET scanning or lumbar puncture
  • Severe visual or hearing impairment
  • History of immunodeficiency disorders
  • Chronic viral hepatitis
  • History of tuberculosis (subjects with no history of TB will be tested for previous TB exposure; a positive test will be exclusionary)
  • History of ophthalmic shingles or ocular herpes simplex virus infection
  • Any live vaccine in the 3 months or any active infection in the 4 weeks before study drug administration
  • Any chronic inflammatory disease that is not adequately controlled or requires immunosuppressive or immunomodulatory therapy
  • T helper cell, cytotoxic T cell, or B cell absolute counts below normal
  • Immunoglobulin (Ig) IgG, IgA, or IgM levels below normal
  • Abnormal results of physical examination, vital signs, or clinical laboratory tests at screening or baseline visits
  • Cardiac factors, including: prolonged QT interval greater than 450 msec from electrocardiograms; history of risk factors for torsade de pointes or the use of concomitant medications that prolong the QT/QTc interval; left bundle branch block; persistent low or high heart rate; persistent low or high blood pressure; history of cardiac arrhythmias; other clinically significant ECG abnormalities
  • Diabetes mellitus or other medical conditions that are not well controlled
  • Malignant neoplasms within the past 5 years (except for basal or squamous cell carcinoma in situ of the skin or localized prostate cancer that did not require systemic therapy)
  • Hypopigmentation conditions (albinism and vitiligo)
  • Known or suspected history of drug or alcohol dependency or abuse within the past 2 years, current use of recreational drugs, or a positive urine drug test
  • Planned surgery that requires general, spinal, or epidural anesthesia during the study
  • Participation in any other interventional clinical study related to cognitive impairment within the past 6 months unless subject received a placebo 
  • Use of any investigational drug or device within 60 days or 5 half-lives of the investigational medication
  • Females who are lactating or pregnant
 

Study Contact
Eisai Medical Services
1-888-422-4743

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

California
Bellflower, CA
Costa Mesa, CA
Glendale, CA
Irvine, CA
Florida
Aventura, FL
Boca Raton, FL
Brooksville, FL
Lake Worth, FL
Orlando, FL
Port Charlotte, FL
Georgia
Atlanta, GA
Savannah, GA
Kansas
Wichita, KS
Michigan
Kalamazoo, MI
New Jersey
Mount Arlington, NJ
Scotch Plains, NJ
North Carolina
Charlotte, NC
Ohio
Dayton, OH
South Carolina
Port Royal, SC
Texas
Dallas, TX
San Antonio, TX

Who Sponsors This Study?

Lead: Eisai Inc.

Collaborator Sponsor

  • Biogen Idec

Source: ClinicalTrials.gov ID: NCT02322021