Start: November 2014
End: December 20, 2019
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?
- 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.
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?
Lead: Eisai Inc.
Source: ClinicalTrials.gov ID: NCT02322021