Clinical Trial to Explore the the Amyloid Beta Draining Effect of Thiethylperazine (TEP) in Subjects With Newly Diagnosed Early-to-mild Dementia Due to Alzheimer's Disease (AD) in Comparison to Healthy Volunteers

Exclusion Criteria

• •1. CSF cut-off values identified during routine Neurochemical Dementia Diagnostics
• •2. History or evidence of other significant neurological disease of the Central Nervous System (such as Parkinson's disease, multi-infarct dementia, fronto-temporal dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supra nuclear palsy, epilepsy, myasthenia gravis, subdural hematoma or multiple sclerosis)
• •3. History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
• •4. Significant neuroimaging abnormalities, previously known or discovered on the MRI scan, including evidence of infection, infarction (\> 3 mm in size), brain tumors (other than small meningiomas), or other focal lesions, multiple lacunas or lacunas in a critical memory structure or severe confluent microvascular disease (but not mild white matter changes, which are frequent with aging)
• •5. History or evidence of moderate congestive heart failure defined by the New York Heart Association criteria (class I-IV)
• •6. Clinical relevant ECG findings, abnormalities, e.g. pro-arrhythmic potential/effects on QT interval (QTc \>450 msec for males, \>470 msec for females, confirmed by manual assessment of ECG parameters)
• •7. History of new cardiovascular event within the last 6 months
• •8. Resting sitting vital signs: Systolic blood pressure ≤ 100 mmHg or ≥ 165 mmHg, Diastolic blood pressure ≤ 60 mmHg or ≥ 100 mmHg, heart rate ≤ 50 beats/min or ≥ 90 beats/min9. Clinically significant renal disease or insufficiency, including but not limited to creatinine value of \>1.5 mg/dl
• •9. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), total bilirubin, or alkaline phosphatase \>2.5 times the upper limit of normal laboratory range, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis) without enzyme elevation
• •10. Positive tested for hepatitis B surface antigen (HBsAG) or hepatitis C virus/antibodies (anti-HCV) for the first time within the last 6 months prior to the Screening Visit
• •11. Positive tested for human immunodeficiency virus (HIV) at Screening Visit
• •12. Fasting triglycerides \>2.5 times of the upper limit of normal
• •13. Uncontrolled diabetes (FBG \> 150 mg/dl)
• •14. Coagulopathy or any kind of anti-coagulant therapy
• •15. Extrapyramidal syndrome
• •16. Elevation of prolactin, e.g. subject with prolactin-dependent breast cancer or pituitary tumor
• •17. History of severe psychiatric disease like psychotic disorder or current anxiolytic or neuroleptic therapy (for dementia-related or other psychiatric disorder) within the last 3 months of enrolment
• •18. Chronic depression or bipolar disorder or history of major depression within the past 2 years or history of any episode of treatment-resistant depression (requiring \> 1 antidepressants, Electroconvulsive Therapy (ECT) etc.)
• •19. Significant history of alcohol abuse or drug abuse within the past 6 months (at the judgment of the investigator)
• •20. Current treatment with TEP or treatment up to 24 month prior to screening
• •21. Known incompatibility of TEP or phenothiazines
• •22. Subject is receiving the following treatment that may interact with TEP, e.g. adrenaline, tricyclic antidepressants, narcotics, bromocriptine, MAO (monoamine oxidase) inhibitors, CYP2D6 inhibitors, tramadol, pentetrazol, levodopa, anticonvulsants, medication causing extrapyramidal symptoms increases the likelihood of central nervous system side effects
• •23. Participation in a clinical trial involving another investigational drug within 4 weeks prior to screening visit
• •24. Women of child bearing potential or women who are pregnant or nursing
• •25. Male subjects with reproductive potential who refuse to use adequate means of contraception during and up to 3 months after stopping treatment with TEP