NL-OMON52785已完成3 期
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer*s Disease - I5T-MC-AACI / TRAILBLAZER-ALZ 2
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eli Lilly
- 入组人数
- 27
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
- 65 至 99（—）
入选标准
- •1. 60 to 85 years of age inclusive, at the time of signing the informed consent.
- •2. Gradual and progressive change in memory function reported by the
- •participant or informant for >=6 months.
- •3. An MMSE score of 20 to 28 (inclusive) at LEAD-IN SCREENING or COMPLETE
- •4. Meet flortaucipir F18 scan (central read) criteria
- •5. Meet florbetapir F18 scan (central read) criteria
- •6. Have a study partner who will provide written informed consent to
- •participate, is in frequent contact with the participant (defined as at least
- •10 hours per week), and will accompany the participant to study visits or be
- •available by telephone at designated times.
- •7. Have adequate literacy, vision, and hearing for neuropsychological testing
- •in the opinion of the investigator at the time of screening.
- •8. Are reliable and willing to make themselves available for the duration of
- •the study and are willing to follow study procedures.
- •9. Males and females will be eligible for this study.
- •10.Capable of giving signed informed consent as described in Section 10.1.3
- •which includes compliance with the requirements and restrictions listed in the
- •informed consent form (ICF) and in this protocol.
排除标准
- •12. Significant neurological disease affecting the central nervous system
- •(CNS), other than AD, that may affect cognition or ability to complete the
- •study, including but not limited to, other dementias, serious infection of the
- •brain, Parkinson*s disease, multiple concussions, or epilepsy or recurrent
- •seizures (except febrile childhood seizures).
- •13. Current serious or unstable illnesses including cardiovascular, hepatic,
- •renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than
- •AD), psychiatric, immunologic, or hematologic disease and other conditions
- •that, in the investigator*s opinion, could interfere with the analyses in this
- •study; or has a life expectancy of <24 months.
- •14. History of cancer within the last 5 years, with the exception of
- •non-metastatic basal and/or squamous cell carcinoma of the skin, in situ
- •cervical cancer, nonprogressive prostate cancer, or other cancers with low risk
- •of recurrence or spread.
- •15. Participants with any current primary psychiatric diagnosis other than AD
- •if, in the judgment of the investigator, the psychiatric disorder or symptom is
- •likely to confound interpretation of drug effect, affect cognitive assessment,
- •or affect the participant*s ability to complete the study. Participants with
- •history of schizophrenia or other chronic psychosis are excluded.
- •16. Are, in the judgment of the investigator, actively suicidal and therefore
- •deemed to be at significant risk for suicide.
- •17. History of alcohol or drug use disorder (except tobacco use disorder)
- •within 2 years before the screening visit.
- •18. Have a history of clinically significant multiple or severe drug allergies,
- •significant atopy, or severe posttreatment hypersensitivity reactions
- •(including but not limited to erythema multiforme major, linear immunoglobulin
- •A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).
- •19. Have any clinically important abnormality at screening, as determined by
- •investigator, in physical or neurological examination, vital signs, ECG, or
- •clinical laboratory test results that could be detrimental to the patient,
- •could compromise the study, or show evidence of other etiologies for dementia.
- •20. Screening MRI which shows evidence of significant abnormality that would
- •suggest another potential etiology for progressive dementia or a clinically
- •significant finding that may impact the patient*s ability to safely participate
- •in the study.
- •21. Have any contraindications for MRI, including claustrophobia or the
- •presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
- •22. Have a centrally read MRI demonstrating presence of ARIA-E, >4 cerebral
- •microhemorrhages, more than 1 area of superficial siderosis, any
- •macrohemorrhage or severe white matter disease at screening.
- •23. Sensitivity to florbetapir F18 or flortaucipir F18.
- •24. Poor venous access.
- •25. Contraindication to PET.
- •26. Present or planned exposure to ionizing radiation that, in combination with
- •the planned administration of study PET ligands, would result in a cumulative
- •exposure that exceeds local recommended exposure limits.
- •27. A corrected QT (QTcF) interval measurement >450 msec (men) or >470 msec
- •(women) at screening (as determined at the investigational site). The site may
- •request a central read prior to making determination of thi
研究者
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