E2609 for Mild Cognitive Impairment Due to Alzheimer's Disease

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?

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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

Who Sponsors This Study?

Lead: Eisai Inc.

Collaborator Sponsor

• Biogen Idec

Source: ClinicalTrials.gov ID: NCT02322021