Start: September 2014
End: August 2019
What Is This Study About?
This clinical trial will assess the efficacy and safety of AZD3293, compared with a placebo, as a possible treatment for early Alzheimers disease.
Do I Qualify To Participate in This Study?
- Gradual and progressive change in memory during the past 6 months or more reported by participant and study partner
- Mini Mental State Examination Score of 21-28 inclusive at screening
- Objective impairment in memory and functioning, as evaluated by memory test and functional measure performed at screening visit
- Meets National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for probable Alzheimer's disease or mild cognitive impairment (MCI) due to Alzheimer's
Must NOT have:
- Significant neurological disease affecting the central nervous system, other than Alzheimer's, that may affect cognition or ability to complete the study, including but not limited to other dementias, serious brain infection, Parkinsons disease, or epilepsy or recurrent seizures
- History of clinically evident stroke or multiple strokes, based on history or imaging results
- History of clinically important carotid or vertebrobasilar stenosis or plaque
- History of multiple concussions with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years
- Major depression or any other psychiatric diagnosis that, in the judgment of the investigator, is likely to confuse study results or affect the participant's ability to complete the study
- History of alcohol or drug abuse or dependence (except nicotine dependence) within the past 2 years
- Within 1 year before the screening visit or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, NYHA class III or IV; hospitalization for or symptom of unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (for example, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia
- Congenital QT prolongation
- History or presence of diabetes, unless disease and serum glucose levels are well controlled and actively managed
- History of cancer within the last 5 years, with the exception of nonmetastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or nonprogressive prostate cancer
- Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study; may include hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Who Is the General Study Contact?
For more information about this clinical trial, please contact Eli Lilly at 1-877-285-4559 or 1-317-615-4559. Refer to ClinicalTrial.gov number NCT02245737.
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?
Source: ClinicalTrials.gov ID: NCT02245737