EUCTR2005-000979-18-CZ进行中（未招募）1 期
A phase IIa/b double-blind, randomised, placebo-controlled, linear trend design dose-ranging study to investigate the effects of 24 weeks of monotherapy with SB-742457 on cognition in subjects with mild to moderate Alzheimer's disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 mild to moderate Alzheimer's disease with MMSE score 12-24 inclusive at the screening visit and 12-26 inclusive at the end of the placebo run-in period .
- •3. Fifty to 85 years of age inclusive.
- •4. Female subjects must be post-menopausal (i.e. >24 weeks without menstrual period) or surgically sterile. Female subjects who have been post-menopausal for < 2 years must undertake pregnancy testing (ßhCG) at Visit 1, which must be negative.
- •5. Subject has the ability to comply with procedures for cognitive and other testing.
- •6. Subject lives with (or has substantial periods of contact with) a permanent 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. (Subjects living in a nursing home are not eligible.)
- •7. 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, full written informed consent on behalf of the subject has been provided by a legally acceptable representative.
- •8. 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
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •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.
- •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: e.g. cerebrovascular disease, structural or developmental abnormality, epilepsy, infectious, degenerative or inflammatory/demyelinating CNS conditions.
- •3. Focal findings on the neurological exam (excluding changes attributable to peripheral injury).
- •4. Untreated abnormal result of any of the following tests: vitamin B12, syphilis serology, thyroid stimulating hormone (TSH), where this is thought to be the cause of, or to contribute to the severity of, the subject’s dementia.
- •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, or current depression (score on Centre for Epidemiological Studies - Depression Scale (CES-D) >18).
- •6. History of known or suspected seizures, including febrile seizures, 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, 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.
- •9. History of alcohol or other substance abuse, according to the DSM-IV criteria.
- •Concomitant Medications
- •10. Treatment with cholinesterase inhibitors (including tacrine), memantine or selegiline is not permitted:
- •within the past 3 months
- •at any point in the past if the treatment was discontinued for lack of efficacy or
- •significant adverse events, which are also likely to occur with SB-742457.
- •11. Current use or use of any of the following within 30 days or 5 half-lives prior to screening (whichever is longer) is not permitted:
- •Any other treatments approved in the countries for treatment of cognitive symptoms of AD
- •Butyrophenones, phenothiazines or atypical antipsychotics
- •Barbiturates
- •MAO inhibitors
- •Any investigational drug
- •PRN use of benzodiazepines or other sedatives/hypnotics (used for hypnotic or anxiolytic effects) with half-life greater than or equal to 6 hours
- •Chronic short or long term use of benzodiazepines
- •Potent Pgp inhibitors (itraconazole, ketoconazole, cyclosporin, loperamide, diltiazem, verapamil, spironolactone, quinidine, bepridil, quinine, carvedilol)
- •12. Use of the following is not permitted unless prescribed at a stable dose for at least 2 months prior to screening (changes to dose during the study must be discussed with the medical monitor):
- •Antidepressants (other than monoamine oxidase
研究者
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