EUCTR2016-001127-32-GB进行中（未招募）1 期
A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer’s Disease
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 432
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. Able to understand and provide signed informed consent, and must be able to sign and date a request for medical records and/or subject privacy form if that is necessary (for example, the Health Insurance Portability and Accountability Act [HIPAA] authorization form in the United States).
- •- from the subject, if the subject is deemed competent to provide informed consent
- •- from the subject’s legally authorized representative with the subject’s assent, if the subject is deemed not competent to
- •provide informed consent
- •2. Male or female, 50 years of age or older
- •3. Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer’s Association (NIA-AA) guidelines
- •4. Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines
- •5. Has an MRI or CT scan (brain imaging) taken during or subsequent to diagnosis of AD, or during the screening period (prior to Baseline)
- •6. Has a Mini-Mental State Examination (MMSE) score of 5 to 26 (inclusive) at Screening
- •7. Has agitation/aggression defined as a Neuropsychiatric Inventory-
- •Clinician rating scale (NPI-C) combined agitation and aggression
- •domain score of =14 at both the Screening and Baseline visits
- •8. Lives at home or in an assisted living facility (but can visit the clinic
- •as an outpatient). Subjects must have been at their current location
- •for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.
- •9. Has a designated study partner/caregiver (e.g., relative, housemate, close personal friend, or professional caregiver) who is in contact with the subject at least 3 times a week on 3 separate days. The
- •study partner/caregiver must:
- •- be willing and able to accompany the subject to all clinic visits,
- •- be capable of routinely monitoring and reporting study drug use,
- •- be regarded by the Investigator as sufficiently informed to report accurately on these areas of the subject’s behavioral and functional status.
- •10. The subject’s study partner/caregiver provides written agreement that they understand the study, including the role of the study
- •partner/caregiver and will participate in the study
- •11. Both subject and study partner/caregiver are fluent in and able to read the local language in which study assessments are administered at the clinical site.
- •12. Both subject and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests
- •13. If taking antidepressants, has been on a stable dose for at least 4 weeks prior to the Baseline visit and should be expected to remain on a stable dose throughout the trial
- •14. If taking cholinesterase inhibitors and/or memantine, has been on a stable dose for at least 12 weeks prior to the Baseline visit and should be expected to remain on a stable dose throughout the trial
- •15. If female, 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 (e.g., oral, intrauterine device [IUD;
- •diaphragm], injectable, transdermal or implantable contraception) or
- •abstinence, for at least one month prior to randomization, during the study, and one month following completion of the study.
- •Females of childbearing potential must have a negative serum human
- •chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine hCG pregnancy test at Bas
排除标准
- •1. The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
- •2. Has a current major depressive disorder episode (within 3 months)
- •according to the Diagnostic and Statistical Manual of Mental
- •Disorders - Fifth Edition (DSM-5) criteria
- •3. Treatment with an antipsychotic medication within 2 weeks of
- •Baseline visit or 5 half-lives, whichever is longer
- •Investigators should not withdraw a subject’s prohibited medication
- •for the purpose of enrolling them into the study unless discontinuation of the medication is deemed to be clinically
- •appropriate (e.g., symptoms are not well-controlled or the subject
- •cannot tolerate the current medication).
- •4. Has brain abnormalities seen on an MRI or CT scan (brain imaging) taken
- •during or subsequent to diagnosis of AD, that can be attributed to diseases or processes other than AD, including but not limited to:
- •- multiple lacunar infarcts or evidence of a single prior infarct >1 cm3;
- •- intracranial mass lesion (including but not limited to meningioma
- •[>1 cm3 with evidence of peritumoral edema]); or
- •- glioma, vascular malformation, or macrohemorrhage.
- •5. Subject or study partner/caregiver has medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments
- •6. Subject requires treatment with a medication prohibited by the
- •protocol (see Section 5.7, Appendix C, and Appendix D)
- •7. Subject has had a myocardial infarction within the last 6 months prior to Screening
- •8. Subject has a known history or symptoms of long QT syndrome
- •9. Subject has a QRS interval <120 msec and whose Fridericia’s corrected QT interval (QTcF) is >460 msec at screening OR subject has a QRS interval =120 msec and QTcF is >480 msec at screening
- •10. Has clinically significant laboratory abnormalities that in the judgment of the Investigator or Medical Monitor would jeopardize the safe participation of the subject in the study
- •11. Has a history of a significant psychotic disorder prior to or concomitant with the diagnosis of Alzheimer’s disease including, but not limited to, schizophrenia or bipolar disorder
- •12. Subject is bedridden or has any significant medical condition that is unstable and that would either:
- •- place the subject at undue risk from study drug or undergoing study
- •procedures; or
- •- interfere with the interpretation of safety or efficacy evaluations
- •performed during the course of the study
- •13. Has participated in or is participating in a clinical trial of any investigational drug, device, or intervention, and within 4 weeks (or five half-lives, whichever is longer) of the Baseline visit
- •14. Subject with sensitivity to pimavanserin or its excipients
- •15. Subject has previously participated in a clinical study with pimavanserin
- •16. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study
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