Alzheimer's disease

The main goal of this trial is to discover the secret, that is, invisible LY2062430, which can reduce Aziz's disease (AD) compared to treatment. The discovery of Huiheimer's treatment method. At the beginning, at the 80th week, the 80th week mixed model repeated measures (MMRM) analysis of 2 main results, namely the 11 Alzheimer’s Disease Assessment Scale-Cognitive Item Scale (ADAS) -Cog11) and Alzheimer’s Disease Cooperative Trial—Daily Activity Checklist (ADCS-ADL). Indeed, it is true that the magnitude of changes in receiving 4LY after treatment will be significantly different in the group.

Solanezumab (LY2062430)

Solanezumab or placebo

solution

400 mg

* Efficacy: ADAS-Cog14 (also used to obtain ADAS-Cog12 and ADAS-Cog11), ADCS-ADL, MMSE, CDR-SB, NPI, vMRI
* Safety: Adverse events and life time after treatment, laboratory test results, changes in electrocardiogram (ECG) and MRI
* Health results: RUD-Lite, EQ-5D Proxy, QoL-AD
* Biological analysis: Medium A� FCSF tau of all patients (evaluated for ethnic group patients in an additional test); amyloid body blood test (in an additional test, for ethnic subgroup patients)
*Pharmacokinetics/Pharmacodynamics: population pharmacokinetics, and its correlation with efficacy, biomarkers, and safety parameters

All patients, whether male or female, must be at least 55 years old and have Alzheimer's disease. They are in line with the National Institute of Neural and Communication Diseases and Stroke/Alzheimer's and Related Diseases Association (NINCDS/ADRDA) for suspected Ah Zheimer’s disease condition; revised Hachinski’s Ischemic Scale (MHIS) score <= 4 points, MMSE score of 16 to 26 points, Geriatric Depression Scale (GDS) short-term score <= 6 points; and the past 2 years The results of magnetic resonance imaging (MRI) or computerized tomography (CT) scans inside are consistent with the diagnosis of Alzheimer's disease. Patients who have other major or unstable diseases, or need to use prescribed drugs, are not allowed to participate in the trial.

1. Does not have a reliable caregiver who is in frequent contact with the patient (≧10 hrs/week)
2. Meets NINDS/AIREN criteria for vascular dementia
3. Dose not have good venous access.
4. Has current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator’s opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of ＜2 years.
5. Has had multiple episodes of head trauma, or a history within the last 5 years of a serious infection disease affecting the brain (including neurosyphilis, meningitis, or encephalitis or head trauma resulting in protracted loss of consciousness.
6. Has a history within the past 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal PSA posttreatment.
7. Has allergies to humanized monoclonal antibodies.
8. Has a known history of HIV, clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reaction.
9. Has a history of chronic alcohol or drug abuse with the past 5 years.
10. Is clinically judged by PI to be at serious risk for suicide.
11. Has a recent (within 6M before screening) or current lab.result indicating a clinically significant lab. abnormality.
12. Has ECG abnormalities obtained at V1 that, in the opinion of the investigator, are clinically significant with regard to the patient’s participation in the study, including corrected QT (QTc) prolongation (Bazett’s corrected QT interval〔QTcB〕 males＞ 458 msec or females＞474 msec).
13. At V1, ALT/SGPI values ≥2 times the ULN (upper limit of normal).AST/SGOT values ≥3 the ULN, or total bilirubin values ≥2 times the ULN.
14. Has any contraindications for MRI studies, including claustrophobia, the presence of metal implants, or cardiac pacemaker.
15. Has received ACHEIs or memantive for less than 4M or has less than 2M of stable therapy on these treatments by V2.(Note: If recently stopped ACHEIs or memantive, patient must have discontinued treatment at least 2M before V2)
16. Has received medication that affect the CNS (except treatment for AD) for less than 4W; that is, doses of chronic medications that affect CNS should be stable for at least 4w before V2.
17. Has had IgG therapy within the last year. Has previously completed or withdrawn from this study or previous participation in any other study investigating active immunization against Aβ.
18. Requires treatment with other monoclonal antibodies.
19. Is currently enrolled clinical trial within the last 30 days.
20. Lacks, in the investigator’s opinion, adequate premorbid literacy to complete the required psychometric tests.
21. Is investigator site personnel directly affiliated with this study or immediate family or is a Lilly employee.