EUCTR2010-020008-31-GB进行中（未招募）1 期
A Single center, Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Psychosis in Alzheimer’s Disease - Pimavanserin in ADP
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 181
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
入选标准
- •1. Male or female patients, 50 years of age or older at baseline, with NINCDS-ADRDA defined possible or probable AD
- •2. Have been a nursing home resident for = 2 weeks prior to Screening and = 4 weeks prior to randomization, not bedridden and expected to remain in the facility throughout the study
- •3. Have psychotic symptoms that developed after the diagnosis of AD was established. These symptoms must include visual and/or auditory hallucinations, and/or delusions
- •4. Patient must have actively experienced and verbally communicated psychotic symptoms during the month prior to the Screening visit (SV1) and weekly during the previous 2 weeks prior to Baseline
- •5. In the opinion of the investigator the patient requires treatment for their ADP symptoms as evidenced by, for example: distress in the subject, excess disability not attributable to factors other than psychosis, disruptive behavior, interference with medical, nursing or rehabilitative care, and/or dangerous to self or others
- •6. Symptoms must be severe enough at Screening (SV1) and at Baseline to warrant treatment with an antipsychotic agent as documented by Domains A and B of the NPI-NH, and defined as a score of 4 or greater on either the Hallucinations (Frequency x Severity) or Delusions (Frequency x Severity) scales OR a total combined score of 6 or greater
- •7. Patients on acetylcholinesterase inhibitor (AChEI) therapy and/or memantine must be receiving stable doses for 3 months prior to the Baseline visit and during the study
- •8. Female patients must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception (such as oral, intrauterine device [IUD; diaphragm], injectable, transdermal or implantable contraception), for at least one month prior to randomization, during the study, and one month following completion of the study
- •9. Willing and able to provide informed consent. If patient is unable to provide written consent due to the severity of dementia, consent must be given by a legally authorized representative
- •10. Subject and staff caregiver acting as informant are willing and able to adequately communicate in English for the purposes of the key endpoint assessments by raters
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 192
排除标准
- •1. Have psychotic symptoms (hallucinations and delusions) which are likely a part of a toxic, metabolic or infection-induced delirium/encephalopathy, psychosis due to substance abuse, psychosis associated with schizophrenia, bipolar disorder or psychotic depression
- •2. The psychotic symptoms occur exclusively during the course of a delirium
- •3. Have a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Alzheimer’s disease including, but not limited to, schizophrenia or bipolar disorder
- •4. Have a score on the MMSE of < 1 or > 22
- •5. Are unable to communicate verbally
- •6. Have a history of any condition which may prevent the administration or completion of essential study assessments (e.g. cerebrovascular ischemic syndrome/stroke that impairs their ability to complete the MMSE)
- •7. Using any of the medications prohibited or in a manner otherwise restricted as described in Appendix 2 of the clinical protocol (Prohibited and restricted Concomitant Medications)
- •8. Current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient’s ability to participate in the study
- •9. Patient has had a myocardial infarction in the last six months
- •10. Patient has moderate to severe congestive heart failure (New York Heart Association class III or IV as described in Appendix 1 of the clinical protocol)
- •11. Known history or symptoms of long QT syndrome
- •12. Has a Screening and Baseline ECG with Bazett’s corrected QT interval (QTcB) of greater than 460 msec if male or 470 msec if female
- •13. Has clinically significant laboratory abnormalities that in the judgment of the investigator would jeopardize the safe conduct of the study
- •14. Patient is pregnant or breastfeeding. Female patients of child-bearing potential must have a negative serum pregnancy test at Screening, and it must be confirmed at Baseline using a dipstick urine pregnancy test
- •15. Patient has any surgery planned during the screening, treatment or follow-up periods
- •16. Patient is likely to have an allergy or sensitivity to pimavanserin based on known allergies to drugs of the same class
- •17. Patient has previously participated in any prior clinical study with pimavanserin, and/or received any other investigational drug within 30 days prior to the Screening Visit
- •18. Patient is judged by the investigator to be inappropriate for the study
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