PHASE II MILD AD, MMSE 20-26

Effect of oral formulation drug XXXXX on Alzheimer's Disease progression as measured by Cerebral 18F-AV-1451 Tau-PET in Mild Alzheimer's Disease Dementia. 

Rationale: 
Oral formulation drug XXXXX, a synthetic small molecule which is a potent inhibitor of β-site amyloid precursor protein (APP)-cleaving enzyme [BACE]1, for the treatment of Alzheimer's disease(Alzheimer's Disease). 

It is hypothesized that inhibition of BACE1 may slow or inhibit the progression of Alzheimer's Disease. A Phase II study, will assess if inhibiting the production of Aβ in the brain through BACE1 inhibition can slow the progression of disease as assessed by biomarkers of neurodegeneration over 52 weeks of treatment. 

Primary Objective: 
To assess the change from baseline in 18F-AV-1451 positron emission tomography (PET) after treatment with drug XXXX 3 mg or 12 mg per day compared with placebo for 52 weeks among patients with mild Alzheimer's disease (AD) dementia and evidence of brain amyloid. 

Inclusion Criteria: 
1. Present with mild Alzheimer's Disease dementia based on the NIA-AA disease diagnostic criteria. 
2. MMSE score of 20 to 26 inclusive. 
3. Is ≥55 years of age and <85 years of age. 
4. Has a florbetapir PET scan consistent with the presence of amyloid pathology at screening. 
5. Patient must have a reliable study partner with whom he/she cohabits or has regular contact. Exclusion Criteria: 

 

Exclusion Criteria:
1. Lack of adequate premorbid literacy, adequate vision, or hearing to complete the require tests. 
2. Significant neurological disease affecting the CNS, other than Alzheimer's Disease, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures. 
3. Current serious or unstable illnesses including retinal, cardiovascular (including unstable ischemic cardiovascular disease), hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease. 
4. History of cancer within the last 5 years, with the exception of non –metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or nonprogressive prostate cancer. 
5. Patients with a current Diagnostic and Statistical Manual of Mental Disorders, diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis other than AD. Patients with history of schizophrenia or other chronic psychosis are excluded. 
6. Is clinically judged by the investigator to be at serious risk for suicide as assessed by medical history. 
7. Ocular pathology that significantly limits ability to reliably evaluate vision or the retina. 
8. History of alcohol or drug use disorder within 2 years before the screening visit. 
9. Congenital QT prolongation. Corrected QT (QTcF) interval measurement >450 msec (men) or >470 msec (females). 
10. Intermittent second- or third-degree (AV) heart block or history of ventricular tachycardia . 
11. Has a cardiac pacemaker. 
12. History of vitiligo and/or current evidence of post -inflammatory hypopigmentation. 
13. Known positive serologic findings for human immunodeficiency virus (HIV) antibodies. 
14. Patients with a past history (suspected or confirmed) of Hepatitis B or Hepatitis C. 
15. Calculated creatinine clearance <30 mL/min. 
16. Alanine transaminase (ALT) ≥2X the upper limit of normal, aspartate aminotransferase (AST) ≥2X ULN, total bilirubin level (TBL) ≥1.5X ULN, or alkaline phosphatase (ALP) ≥1.5X ULN at screening. 
17. Contraindication to MRI or PET or poor venous access for blood draws. 

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