NL-OMON51159已完成2 期
A Phase 2a, Proof-of-Concept, Open-Label Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Obicetrapib in Patients with Early Alzheimer*s Disease (Hetero/Homozygote APOE4 Carriers) - Obicetrapib in early Alzheimer's disease (Hetero/Homozygote APOE4 Carriers)
ewAmsterdam Pharma B.V.0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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: 50-75 years of age at the Screening Visit.
- •2. Males, or females who are post-menopausal or otherwise not of child-bearing
- •a. Women are not considered to be of childbearing potential if they meet 1 of
- •the following criteria as documented by the Investigator:
- •i. They have had a hysterectomy or tubal ligation at a minimum of 1 cycle prior
- •to signing the ICF; or
- •ii. They are postmenopausal, defined as *1 year since their last menstrual
- •period for women *55 years of age or *1 year since their last menstrual period
- •and have a follicle stimulating hormone (FSH) level in the postmenopausal range
- •for women <55 years of age
- •b. Men whose partners are of childbearing potential must agree to use an
- •effective method of avoiding pregnancy from screening to 90 days after the last
- •visit. Effective methods of avoiding pregnancy are contraceptive methods with a
- •Pearl index of <1 used consistently and correctly (including implantable
- •contraceptives, injectable contraceptives, oral contraceptives, transdermal
- •contraceptives, intrauterine devices, diaphragm with spermicide, male or female
- •condoms with spermicide, or cervical cap) or a sterile sexual partner;
- •3. Diagnosis of AD based on the NIA-AA Research Framework criteria:
- •Biomarker classification A+T+N+ or A+T+N- based upon:
- •a. CSF profile consistent with AD (an Aβ42 concentration of <1000 pg/mL AND
- •phosphorylated tau (p-Tau) >19 pg/mL, or a ratio of p-Tau/Aβ42 of >=0.020 taken
- •during the Screening period prior to the day of the first dose of study
- •medication or,
- •b. Documented evidence of a CSF profile consistent with AD obtained within the
- •previous 12 months, or
- •c. Documented amyloid positron emission tomography (PET) scan evidence acquired
- •within the previous 12 months.
- •4. AD Clinical Stage 3 or 4 based on the NIA-AA Research Framework criteria
- •a. Have a mini-mental state examination (MMSE) score at Screening and baseline
- •b. Clinical Dementia Rating scale-Sum of Boxes (CDR-SB) global score >=0.5 and
- •<=1 with memory box score >=1.0.
- •5. Able to speak, read and write the local language fluently.
- •6. Have an APOE genotype of E4/E4 or E3/E4.
- •7. Patients 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) 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.
- •8. Patient and study partner are willing to consent to all study procedures.
排除标准
- •1. Other than AD, neurologic or medical disorder which may impair cognition
- •including: head trauma, seizure disorder, neurodegenerative disease,
- •hydrocephalus, cerebral/spinal hematoma, inflammatory disease, central nervous
- •system infection (eg, 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.
- •2. Any contra-indication to undergo magnetic resonance imaging (MRI), as judged
- •by Investigator or radiologist.
- •3. MRI of the brain indicative of significant abnormality, including, but not
- •limited to, prior hemorrhage or infarct >1 cm3, >3 lacunar infarcts, deep white
- •matter lesions corresponding to a Fazekas score of 3, cerebral contusion,
- •encephalomalacia, aneurysm, vascular malformation, subdural hematoma,
- •hydrocephalus, space-occupying lesion (eg, abscess or brain tumor such as
- •meningioma). Small incidental meningiomas may be allowed if discussed and
- •approved by the Principal Investigator (PI).
- •4. History of any of the following neurological, psychiatric or medical
- •conditions:
- •a. History of large vessel stroke
- •b. History of myocardial infarction or unstable angina within the previous 12
- •c. Type 1 diabetes and uncontrolled type 2 diabetes (hemoglobin A1c [HbA1c] >8%)
- •d. Systemic blood pressure >150/90 mmHg on 3 separate determinations
- •e. History of hyperaldosteronism
- •f. Significant renal or hepatic dysfunction
- •g. Current or previous hepatitis B infection (defined as positive test for
- •hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody
- •(anti-HBc). Subjects with immunity to hepatitis B (if due to natural infection
- •defined as negative HBsAg, positive hepatitis B antibody [anti-HBs] and
- •positive anti-HBc; if due to vaccination defined as negative HBsAg, negative
- •anti-HCV and positive anti-HBs) are eligible to participate in the study
- •h. History or positive test at Screening for hepatitis C virus antibody
- •(anti-HCV)
- •i. History or positive test at Screening for human immunodeficiency virus (HIV)
- •j. Diagnosed with cancer with metastatic potential within the last 5 years
- •other than carcinoma in situ of the breast or cervix, or basal cell carcinoma
- •of the skin that has been completely excised
- •k. Major depressive episode requiring initiation of medication or
- •hospitalization within the previous 90 days
- •l. Presence of hallucinations or delusions
- •m. Surgery within 12 weeks of Screening
- •5. Any of the following laboratory abnormalities at Screening
- •a. Clinically significant (as determined by a cardiologist or local PI) 12-lead
- •ECG abnormalities
- •b. Any serum chemistry value (eg, aspartate aminotransferase [AST], alanine
- •aminotransferase [ALT], alkaline phosphatase, creatine kinase [CK], total
- •bilirubin etc) >2x the upper limit of normal (ULN) on 2 successive
- •determinations less than 2 weeks apart
- •c. Serum creatinine above the ULN or estimated glomerular filtration rate
- •(eGFR) <60 mL/min
- •d. Platelet count, international normalized ratio (INR), prothrombin time (PT)
- 另有 3 项未显示
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