EUCTR2008-000826-37-CZ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)
- •5.History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, major depressive disorder (according to DSM-IV) in the past year, or current active depression requiring initiation of treatment
- •Note: If not currently treated, but active depression is suspected, the Cornell Scale for Depression in Dementia (CSDD) may be used by the Investigator as a guide for deciding whether a prospective subject requires treatment. If the subject has a CSDD score >7, the Investigator should decide if the subject has depression in need of prescribed medication, and a CSDD score > 12 is considered a strong indicator that treatment is needed. Subjects will be allowed to re-screen after their depression has been adequately managed for > 3 months
- •6.History of known or suspected seizures, including febrile seizures (except a clearly documented single brief febrile convulsion in infancy), unexplained recent loss of consciousness or history of significant head trauma with loss of consciousness
- •7.Known history of photosensitivity or presence of skin conditions (such as porphyria, photo-dermatitis) or treatments (such as medications, UV light) that may predispose the subject to photosensitivity reactions
- •8.Any significant medical conditions which, in the opinion of the investigator, may be exacerbated by administration of donepezil (e.g. chronic obstructive pulmonary disease, asthma, peptic ulcer disease)
- •9.History or presence of significant cardiovascular, gastro-intestinal, endocrine, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study
- •10.History of alcohol or other substance abuse, according to the DSM-IV criteria, or recent or remote history of the same if that could be a contributing factor to the dementia
- •11.Participation in another investigational drug or device study in AD during the 60 days prior to the Screening visit (Visit 1), or
研究者
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