NL-OMON56092招募中不适用
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBC-Ab002 in Persons with Early Alzheimer's Disease - IBC-01-01
ImmunoBrain Checkpoint, Inc0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age range: 50-80 years of age at the Screening visit
- •2. Diagnosis of early AD based on the NIA-AA Research Framework criteria,
- •regardless of APOE gene status
- •a. Biomarker classification A+T+N+ or A+T+N- based upon Screening CSF profile
- •consistent with AD defined by either of the following criteria:
- •i. CSF Aβ42 < 1000 pg/mL and pTau181 > 19 pg/mL
- •ii. CSF pTau181/Aβ42 ratio > 0.020
- •b. AD Clinical Stage 3 or 4 based on the National Institute on Aging and
- •Alzheimer's Association (NIA-AA) Research Framework criteria
- •i. Gradual and progressive change in memory function reported by the
- •participant or informant for >=6 months
- •ii. Have a Mini-Mental State Examination (MMSE) score at Screening between
- •20-28 inclusive
- •iii. Clinical Dementia Rating Scale (CDR) global score at Screening of 0.5 or 1
- •with memory box score >= 0.5
- •3. Able to speak, read and write the local language fluently
- •4. With respect to symptomatic treatment for Alzheimer*s disease, subjects
- •should either be:
- •a. Not treated with any approved treatments for AD with a reasonable
- •expectation that, based on the course of illness, need for treatment is not
- •imminent and the patient should not be initiated on treatment for the length of
- •the study, OR
- •b. Stabilized on an approved medication(s) other than anti-Ab antibodies for
- •the treatment of AD for at least 3 months prior to Baseline. The dose of the AD
- •treatment should remain the same after entering the study
- •5. Subject has a study partner who spends at least 10 hours/week with the
- •patient, and can attend all visits with the patient, report accurately on the
- •subject*s status and ensure compliance with all study requirements
排除标准
- •1. Females who are not postmenopausal at Screening as defined by amenorrhea for
- •at least 12 consecutive months or who have not been sterilized surgically (i.e.
- •bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all
- •with surgery at least 1 month before Screening)
- •2. Males who are fertile but refuse to practice double-barrier methods of
- •contraception with female partners of childbearing potential
- •3. Other than AD, neurologic or medical disorder which may impair cognition
- •including: head trauma, seizure disorder, neurodegenerative disease,
- •hydrocephalus, cerebral / spinal hematoma, inflammatory disease, CNS infection
- •(e.g. encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder
- •(including hypoxic or hypoglycemic episodes), or endocrine disorder, or any
- •significant medical conditions that, in the opinion of the Investigator, would
- •prohibit their participation in the study
- •4. As assessed by the central MRI reader,
- •a. Magnetic Resonance Imaging (MRI) evidence of a) more than three lacunar
- •infarcts, b) territorial infarct or macroscopic hemorrhage, or c) deep white
- •matter lesions corresponding to a Fazekas score = 3
- •b. Presence of any structural lesion that could potentially explain the
- •subject*s cognitive impairment, or place the subject at risk for AEs during the
- •trial. Examples include but are not limited to: cerebral contusion,
- •encephalomalacia, aneurysm or vascular malformation, infective lesion,
- •intraparenchymal tumor, meningioma or arachnoid cyst larger than 1 cm in
- •longest diameter
- •c. More than 5 Amyloid-Related Imaging Abnormalities-Hemorrhages (ARIA-H)
- •(including microbleeds and areas of leptomeningeal hemosiderosis (LH)) or more
- •than 3 areas of LH
- •5. Any contra-indication to undergo MRI, as judged by local PI or radiologist,
- •including but not limited to presence of pacemaker, aneurysm clips, artificial
- •heart valves, ear implants, ventriculoperitoneal shunt, foreign metal objects
- •in the eyes, skin or body or any other circumstance which would contraindicate
- •an MRI scan or impair MRI image quality, or history of claustrophobia or of not
- •tolerating MRI scanning procedures
研究者
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