EUCTR2008-004012-13-IT进行中（未招募）不适用
A dose ranging, randomized, double blind, parallel-group placebo-controlled multi-center study of RO5313534 used as add-on to donepezil treatment in patients with mild to moderate symptoms of Alzheimer s Disease.
F.Hoffmann-La Roche Ltd - Pharmaceutical Division, PDR0 个研究点目标入组 360 人开始时间: 2009年4月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Probable AD, based on the NINCDS/ADRDA and DSM-IV criteria. 2. Males, females of non-childbearing potential: i.e. more than two years after the cessation of menses or surgically sterile by means of hysterectomy, bilateral oopherectomy or tubal ligation). Additional blood tests will be done if required by the local regulations/guidelines/EC/IRB for further confirmation of non-childbearing potential. 3. Age range: a minimum of 50 years of age at the time of screening visit. 4. Non smokers and not using nicotine-containing products for at least 3 months prior to baseline. 5. Have a MMSE score at screening between 13 and 22 inclusive. 6. Have a Modified Hachinski Ischemia Scale score of `?¤ 4 (see Appendix 5) 7. Are under stable donepezil treatment given at a fixed dose either 5 or 10 mg daily for at least 4 months prior to baseline. 8. Adequate vision & hearing (physical ability to perform all the study assessments). 9. Not requiring nursing home care. 10. Have a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker or nurse) who is considered reliable by the Investigator in providing support to the patient to ensure compliance with study treatment, accompany patient to study visits and help with protocol procedures, and who is also able and willing to provide input for completing the caregiver scales and sign the caregiver consent form. 11. Are cooperative, willing and able to complete all aspects of the study, and capable of doing so either alone or with the help of a responsible caregiver. Patients who make an effortful attempt to perform CANTAB at screening but are unable to complete all aspects may be considered eligible if other eligibility criteria are met. 12. Signed a written consent for participation in the study (cosigned by the patient s next of kin or caregiver, if required by the local regulations/guidelines/EC/IRB).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •CNS 1. Dementia due to condition other than AD; 2. Other significant neurological disorder, including current diagnosis of epilepsy, stroke (patients found with clinically silent lacunar stroke at MRI or CT may be allowed if the lesion is unique, less than or equal to 1 cm in maximal diameter and not located in any of the following regions:hippocampus of either hemisphere, head of the left caudate, dorsomedial region of the left thalamus), history of brain injury, Parkinson's disease; 3. Background of mental retardation; 4. Untreated/non stabilized Major Depressive Disorder (DSMIV); 5. Bipolar disorder, schizophrenia or any serious psychiatric condition (Axis I Disorder, DSM-IV-TR); 6. At risk of suicide in the opinion of the investigator; 7. Uncontrolled behavioral symptoms incompatible with compliance or evaluability: e.g. severe agitation, lack of impulse control, violence, severe dysphoria;8. Alcohol and/or substance abuse or dependence (DSM 'IV) in the past 2 years. Et al..
研究者
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