EUCTR2016-000429-38-DK进行中（未招募）1 期
A Phase 2a Study of the Safety, Tolerability, and Pharmacodynamic Effects of Pexidartinib 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）
- 入组人数
- 34
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.Signed and dated written informed consent from the subject has been obtained in accordance with the local regulations. The subject’s study partner must also consent to participate in the study.
- •2.Diagnosis of probable AD according to the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders (NINCDS-ADRDA) criteria.
- •3.Aged 55 to =85 years, inclusive.
- •4.At the time of screening assessments, resides in the community (not in an assisted living facility or long term care nursing facility).
- •5.Mini-Mental State Examination score of 16 to 26, inclusive, at screening.
- •6.Adequate hematologic, hepatic, and renal function.
- •7.Able to ingest oral medication.
- •8.For subjects participating in Part 2 only: evidence of microglial neuroinflammation: [11C](R)PK11195 uptake at screening that is =20% above the normal mean.
- •9.Subject has a reliable study partner or caregiver (eg, spouse, sibling, close friend) who, in the investigator’s judgement, has frequent, direct contact with the subject at least 4 days a week, can accompany the subject to all visits, and is also able to provide information to study investigator/staff via telephone contact.
- •10.Subject or study partner understands the study procedures and agrees to return for follow-up visits and procedures in the event of discontinuation of study drug.
- •11.Reliable study partner must supervise administration of study medication.
- •12.Stable use of cholinesterase inhibitors and memantine is permitted if the doses are stable for 3 months prior to enrollment. The dose of these medications should be stable throughout the study unless it becomes clinically necessary to adjust the dosage.
- •13.Stable use of antidepressants is permitted if the doses are stable for 4 weeks prior to enrollment. The dose of these medications should be stable throughout the study unless it becomes clinically necessary to adjust the dosage.
- •14.Women must be surgically sterile (bilateral tubal ligation, both ovaries removed, or hysterectomy) or postmenopausal for at least 2 years.
- •15.Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of the study drug.
- •16.Agrees not to participate in any other investigational study while participating in this protocol.
- •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 2
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •1.Has significant neurological disease other than AD that may affect cognition.
- •2.Has history or screening brain MRI scan results indicative of any other significant abnormality.
- •3.Has a history of clinically significant stroke.
- •4.Has a Modified Hachinski Ischemia Score =4.
- •5.For subjects participating in Part 2 only: Is unsuitable for magnetic resonance imaging (MRI) scanning as assessed by the investigator.
- •6.Has current evidence or history in the past 2 years of epilepsy; seizure; focal brain lesion; head injury with loss of consciousness; or Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, or severe alcohol or substance abuse.
- •7.Has sensory impairment that would prevent him/her from participating in the study or cooperating with the protocol.
- •8.Has used another investigational agent within 1 month of screening.
- •9.Has prior exposure to pexidartinib.
- •10.Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •11.If receiving behavioral medications (including antidepressants, antipsychotics, or anxiolytics), doses must have been stable for at least 4 weeks prior to enrollment.
- •12.Has active neoplastic disease or any medical condition that requires concurrent immunosuppression.
- •13.At screening, has psychosis or hallucinations as determined by Neuropsychiatric Inventory or Geriatric Depression Scale short form scores =6.
- •14.Has any unstable cardiovascular disease, uncontrolled diabetes, chronic inflammatory, or infections conditions.
- •15.Is using Coumadin or Coumadin related medications.
- •16.Is unable to take oral medication or has significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
- •17.At baseline, has mean corrected QT interval (QTc) using the Fridericia method (QTcF) = 450 ms (males) or = 470 ms (females).
- •18.Has clinically significant cardiac arrhythmias, including bradyarrhythmias and/or requires anti arrhythmic therapy (excluding beta blockers or digoxin). Subjects who have controlled atrial fibrillation are not excluded from participation.
- •19.Has congenital long QT syndrome or is taking concomitant medication(s) known to prolong the QT interval (eg, tricyclics, azithromycin, methadone).
- •20.Has > Grade 1 (high or low) serum potassium, magnesium, or calcium levels.
- •21.Has hypertension, which is defined as a systolic blood pressure > 140 mmHg or diastolic pressure > 95 mmHg despite optimal medical management.
- •22.Has an ongoing active infection at the time of screening.
- •23. Has a positive tuberculin skin test at screening.
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