EUCTR2008-000827-25-CZ进行中（未招募）不适用
Study AZ3110866, a fixed dose study of SB-742457 versus placebo when added to existing donepezil treatment in subjects with mild-to-moderate Alzheimer's disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 672
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 (Section 11.12 Appendix 12) and National Institute of
- •Neurological and Communicative Diseases and Stroke/Alzheimer’s Disease and
- •Related Disorders Association (NINCDS-ADRDA) criteria (Section 11.13
- •Appendix 13).
- •2. Subject has a documented history of at least 6 months of ongoing donepezil therapy
- •for Alzheimer’s disease, with stable dosing of 5-10mg/day for at least the last 2
- •months (and with no intent to change for the duration of the study).
- •3. Subject has MMSE (Section 11.10 Appendix 10) 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 (Section 11.14 Appendix 14) = 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 therapy]1 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 Section 11.4 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
- •Other Causes for Dementia
- •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
- •(Section 11.15 Appendix 15).
- •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 disease1.
- •3. Focal findings on the neurological exam (excluding changes attributable to 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).
- •Confounding Medical Conditions
- •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 ;Section 11.16
- •Appendix 16) in the past year, or current active depression requiring initiation of
- •Note: If not currently treated, but active depression is suspected, the Cornell Scale
- •for Depression in Dementia (CSDD ;Section 11.9 Appendix 9) 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. History or presence of significant cardiovascular, gastro-intestinal, endocrine, hepatic or renal disease or other conditions 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.
- •9. History of alcohol or other substance abuse, according to the DSM-IV criteria
- •(Section 11.17 Appendix 17), or recent or remote history of the same if that could be
- •a contributing factor to the dementia.
- •Concomitant Medications
- •10. Participation in another investigational drug or device study in AD during the 60
- •days prior to the Screening visit (Visit 1), or within
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