PHASE III MILD AD, MMSE 20-26

A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of oral formulation drug XXXXX in Mild Alzheimer's Disease Dementia 

Rationale: 
Drug XXXXX is a brain-permeable inhibitor of human Beta-site amyloid precursor protein-cleaving enzyme 1(BACE1/β-secretase). It is being developed for the modification of the clinical course of Alzheimer's disease (AD) by slowing disease progression in patients with early Alzheimer's Dementia . 

Primary Objective: 
To test the hypothesis that drug XXXXX, administered orally at doses of 20 and 50 mg daily for 78 weeks, will slow the decline of Alzheimer's Disease as compared with placebo in patients with mild AD dementia 

Inclusion Criteria: 
Patients with mild Alzheimer's Disease dementia meet all of the following criteria at screening. 
1. Male or female, aged 55 to 85 years. 
2. Patient must meet the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (NIA-AA) criteria for probable Alzheimer's Disease dementia. 
3. Mini-Mental State Examination (MMSE) score of 20 to 26 inclusive. 
4. Florbetapir F 18 positron emission tomography (PET) positive for presence of amyloid. 
5. Patient must have a reliable study partner with whom he/she cohabits or has regular contact. 

 

Exclusion Criteria: 
1. Significant and/or current neurological disease affecting the central nervous system, other than AD, including but not limited to, other dementias, repetitive head trauma, serious infection of the brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease. 
2. Patients with any current primary psychiatric diagnosis other than AD. Patients with history of schizophrenia or other chronic psychosis are excluded. 
3. History of alcohol or drug use disorder within 2 years. 
4. Within 1 year, any of the following: myocardial infarction; moderate or severe congestive heart failure; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia 
5. Congenital QT prolongation. Corrected QT (QTcF) interval measurement >470 msec. 
6. Intermittent second- or third-degree atrioventricular (AV) heart block. 
7. History of malignant cancer within the last 5 years, exception, non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or non-progressive prostate cancer. 
8. Current serious or unstable clinically important systemic illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders. 
9. History of vitiligo and/or current evidence of post-inflammatory hypopigmentation. 
10. Uncontrolled hypertension, that is, supine systolic BP >165 mmHg or diastolic BP >95 mmHg. 
11. Known positive serologic findings for human immunodeficiency virus (HIV) antibodies. 
12. Patients with past history (suspected or confirmed) of Hepatitis B and Hepatitis C. 
13. Calculated creatinine clearance <30 mL/min 
14. Alanine aminotransferase (ALT) ≥2x the upper limit of normal, aspartate aminotransferase (AST) ≥2x ULN, total bilirubin 1.5x ULN, or alkaline phosphatase (ALP) ≥1.5x ULN. 
15. Has any contraindications for MRI studies 

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