EUCTR2008-000826-37-EE进行中（未招募）不适用
Study AZ3110865, a study comparing SB-742457 or donepezilversus placebo in subjects with mild-to-moderate Alzheimer’sdisease
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 576
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. Male or female subject with a clinical diagnosis of probable Alzheimer's disease in
- •accordance with Diagnostic and Statistical Manual of Mental Disorders, Fourth
- •Edition (DSM-IV) criteria and National Institute of Neurological and
- •Communicative Diseases and Stroke/Alzheimer’s Disease and Related Disorders
- •Association (NINCDS-ADRDA) criteria
- •2. Subject has a documented history of symptoms of AD for at least 6 months prior to
- •entry into the study
- •3. Subject has MMSE score 12-24 inclusive at Screening and a baseline MMSE score
- •10-26 inclusive. The MMSE score at baseline must be within ± 3 points of the
- •Screening value
- •4. Hachinski Ischaemia score = 4 at Screening
- •5. Age = 50 to = 85 years
- •6. A female subject must be:
- •a. Of non-childbearing potential (i.e., any female who is post-menopausal [ > 1 year
- •without menstrual period in the absence of hormone replacement therapy1] or
- •surgically sterile; or,
- •b. If pre-menopausal or menopausal for 1 year or less, must have a negative pregnancy test and must not be lactating at the Screening and Baseline Visits and agrees to satisfy one of the requirements listed in Appendix 4
- •7. Subject has the ability to comply with procedures for cognitive and other testing in
- •the opinion of the investigator
- •8. Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend all visits, oversee the subject's compliance with protocol specified procedures and study medication, and report on subject's status
- •Note: A non-cohabiting caregiver must spend sufficient time with the subject so that
- •in the opinion of the Investigator, the caregiver can reliably assess cognitive
- •function, activities and behaviour, and report on the subject’s compliance and health.
- •GSK should be consulted if adequacy of a caregiver situation is in doubt. However,
- •as guidance, the ability for a caregiver to meet his/her expected responsibilities for
- •this study would normally be possible when the caregiver spends no less than 10
- •hours per week with the subject, divided over multiple days
- •9. Subject has provided full written informed consent prior to the performance of any
- •protocol-specified procedure; or if unable to provide informed consent due to
- •cognitive status, subject has provided assent and full written informed consent on
- •behalf of the subject has been provided by a legally acceptable representative
- •10. Caregiver has provided full written informed consent on his/her own behalf prior to the performance of any protocol-specified procedure
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •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
- •1. Diagnosis of possible, probable or definite vascular dementia in accordance with
- •National Institute of Neurological Disorders and Stroke-Association Internationale
- •pour la Recherche l’Enseignement en Neurosciences (NINDS-AIREN) criteria
- •2. History and/or evidence (CT or MRI scan performed within the past 12 months or at Screening) of any other central nervous system (CNS) disorder that could be
- •interpreted as a cause of dementia (in the opinion of the investigator): e.g.
- •cerebrovascular disease (stroke, haemorrhage), structural or developmental
- •abnormality, epilepsy, infectious, degenerative or inflammatory/demyelinating CNS
- •conditions, Parkinson’s disease2
- •3. Focal findings on the neurological exam (excluding changes attributable to AD or
- •peripheral injury)
- •4. Evidence of the following disorders: current vitamin B12 deficiency, positive
- •syphilis serology (unless neurosyphilis was ruled out) or active thyroid dysfunction
- •(particularly suggestive of hypothyroidism), including abnormally high or low serum
- •levels of thyroid stimulating hormone (TSH), where this is thought to be the cause
- •of, or to contribute to the severity of, the subject’s dementia
- •(Note: testing is required for each parameter only when no result is available from
- •previous 12 months)
研究者
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