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E2609 for Mild Cognitive Impairment Due to Alzheimer's Disease

Active, not recruiting

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.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years Both No
November 2014
July 31, 2022
700

  • 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

  • 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

Participants in this Phase II study will take a low, medium, or high dose of E2609, a tablet taken once per day with food. E2609 is a BACE inhibitor, an experimental drug that inhibits an enzyme that leads to the overproduction of beta-amyloid in the brains of people with Alzheimer's disease. This trial will test whether E2609 can decrease beta-amyloid production, improve symptoms, and slow disease progression.

Name City State Zip Status Primary Contact
CITrials
Bellflower California 90706

ATP Clinical Research
Costa Mesa California 92626

Behavioral Research Specialists
Glendale California 91206

Nervepro Research
Irvine California 92618

JEM Research Institute
Atlantis Florida 33462

Aventura Neurologic Associates
Aventura Florida 33180

Elite Research and Clinical Trials LLC
Aventura Florida

Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
Boca Raton Florida 33486

Bradenton Research Center Inc
Bradenton Florida

Quantum Labs Inc
Deerfield Beach Florida 33064

Berma Research Group
Hialeah Florida 33016

Galiz Research
Hialeah Florida 33016

Alzheimers Research and Treatment Center
Lake Worth Florida 33449

Compass Research, LLC
Melbourne Florida 32940

Miami Jewish Health Systems Inc
Miami Florida 33137

CCM Clinical Research Group
Miami Florida

Neurostudies Inc
Port Charlotte Florida 33952

Meridien Research
Spring Hill Florida 34609

Neurology Clinical Research, Inc.
Sunrise Florida 33351

Infinity Clinical Research
Sunrise Florida

Stedman Clinical Trials
Tampa Florida 33613

Atlanta Center for Medical Research
Atlanta Georgia 30331

Neurostudies Inc
Decatur Georgia 30033

RTR Medical Group LLC
Savannah Georgia 31419

Southeastern Georgia Geriatrics
Savannah Georgia

Georgia Neurology and Sleep Medicine Associates
Suwanee Georgia 30024

Heartland Research Associates LLC
Wichita Kansas 67207

Borgess Research Institute
Kalamazoo Michigan 49048

Precise Research Centers
Flowood Mississippi 39232

The NeuroCognitive Institute
Mount Arlington New Jersey 07856

Cognitive Research Center of New Jersey
Springfield New Jersey 7081

ANI Neurology, PLLC dba Alzheimer's Memory Center
Charlotte North Carolina 28270

Ohio Clinical Research Partners LLC
Canton Ohio 44718

Neurology Diagnostics, Inc.
Dayton Ohio 45459

Alzheimers Research and Treatment Center
Willow Grove Pennsylvania 19090

Abington Neurologic Associates
Willow Grove Pennsylvania

Rhode Island Mood and Memory Research Institute
East Providence Rhode Island 2914

Coastal Neurology
Port Royal South Carolina 29935

Neurology Consultants of Dallas, PA
Dallas Texas 75231

Clinical Trials of Texas Incorporated
San Antonio Texas 78229

Lifetree Clinical Research
Salt Lake City Utah 84107

Quorum Review, Inc.
Seattle Washington 98101

Eisai Inc.

  • Biogen Idec

Name Phone Email
Eisai Medical Services 1-888-422-4743

NCT02322021

A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Proof-of-Concept, Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's