EUCTR2005-003475-20-CZ进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of Bifeprunox in the Treatment of Elderly Subjects with Psychosis and Behavioural Disturbances Associated with Dementia of the Alzheimer's Type
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •Current Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text
- •Revision (DSM-IV TR) diagnosis of Dementia of the Alzheimer.s Type (code 294.11);
- •In order to be eligible to participate in this study, subjects must meet the following criteria:
- •1. Delusions or Hallucinations =1 month, at least moderate in severity (i.e. impair
- •subjects. functional capacity or cause them to pose a threat to themselves).
- •2. Fulfill the criteria for behavioral disturbance. defined as: A score of greater than 3 on any one of the following BPRS items:
- •- Hostility,
- •- Suspiciousness,
- •- Uncooperativeness (hostile-suspiciousness factor);
- •Or a score of greater than 6 on the sum of these three items;
- •3. The subject's authorized Legal Representative must understand the nature of the study and must provide written informed consent with the subject assent or based on country specific laws the subject's next of kin must provide concent/assent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen);
- •4. Each subject must be able to speak, read, understand and possess the ability to follow simple instructions in English or in their native language if the Investigator is fluent in that language. All required documents, including the informed consent, will be translated into that language as appropriate;
- •5. Male or female subject's = 65, but = 90 years of age.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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. Current evidence of clinically significant, untreated or uncontrolled neurological, hematological, immunological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, pulmonary or infectious disease, or metabolic disturbance that would possibly interfere with the subject's participation in the study. Patients with evidence of stroke, hepatitis or head trauma should be excluded;
- •2. Subjects with other current Axis I primary psychiatric diagnoses that may interfere with the interpretation of efficacy and/or safety evaluations, e.g., Bipolar Disorder, Schizophrenia or Schizoaffective Disorder. Patients with current depressive and
- •anxiety disorders may be considered on a case-by-case basis.
- •3. Any clinically significant abnormal laboratory data (e.g., creatinine, aspartate
- •transaminase (AST) or alanine transaminase (ALT) greater than 2X the upper limit of normal), vital sign, physical examination at screening or baseline which in the opinion of the Investigator would preclude study participation or interfere with the assessment of safety;
- •4. Vascular dementia or dementia due to substance abuse, head trauma, or HIV disease;
- •5. History of seizure disorder requiring treatment within the previous 12 months;
- •6. Current alcohol or drug dependence (DSM-IV TR. criteria), or history of substance abuse within the past year;
- •7. Clinical or radiological evidence of stroke;
- •8. Subjects with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension by history or physical exam, defined as a decrease of 30 mmHg or more in systolic BP and/or a decrease of 20 mmHg or more in diastolic BP after at least two minutes standing compared to the previous lying BP. The abnormal value must be confirmed at two separate measurements;
- •9. Subjects who experience significant difficultly ingesting oral medications as well as patients with clinically significant dysphagia, esophageal motility disorders, hiatal hernia, or esophageal stricture.
- •10. History of multiple episodes of aspiration pneumonia (= 2) in the 90 days prior to the baseline visit.
- •11. Subjects with clinically significant abnormal ECG findings, including clinically
- •relevant conduction disturbances identified at screening. These include subjects with any one or more of the following:
- •-Subjects with a cardiac pacemaker at screening or who require the implantation of a pacemaker during the study;
- •- Subjects with clinically significant (or potentially clinically significant) abnormal ECG findings that are present at screening or that are identified any time throughout the study, including: atrial fibrillation / flutter, prolonged QTc using Bazett’s formula (> 450 msecs for men and > 470 msecs for women), complex premature ventricular contractions, other clinically relevant conduction disturbances, incomplete right bundle branch blocks, potentially clinically significant ST/T wave changes.
- •Subjects with first degree A-V block can be allowed in the trial on a case-by-case basis following review with the Quintiles Medical Advisor)
- •12. History of repeated vasovagal syncope;
- •13. Clinical evidence of Parkinson.s disease, Lewy body disease, Huntington’s disease, tardive dyskinesia, or multiple sclerosis;
- •14. Subjects judged by the Investigator as being at significant risk of suicide and/or
- •violent behavior;
- •15. Subjects receiving a depot antipsychotic medication within one dose interval prior to Screening;
- •16. Subjects who, in the Investigator.s opinion, have failed to respond to a
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