EUCTR2019-001476-11-IT进行中（未招募）1 期
A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AL002 IN PARTICIPANTS WITH EARLY ALZHEIMER’S DISEASE - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Alector Inc.
- 入组人数
- 265
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.PT (PT) has any evidence of a condition other than AD that may affect cognition 2.PT has history or presence of vascular disease that has the potential to affect cognitive function, or stroke within past 2 years, or ischemic attack within last 6 months 3.PT has history of severe, clinically significant CNS trauma, or history or presence of intracranial tumor, or presence of infections that affect brain function or history of infections with neurologic sequelae 4.PT has history or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits, or uveitis with medical intervention, chronic inflammatory or degenerative condition of the eye, current eye infection, any ongoing eye disorder requiring injectable medical therapy or planned invasive eye procedure during the study period 5.PT has history of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder, or is at risk of suicide in the PI´s opinion 6.PT has history of alcohol and/or substance use disorder within the past 2 years 7.PT has MRI evidence of a. >2 lacunar infarcts. b. Any territorial infarct >1 cm3. c. Any white matter lesion as per protocol 8.PT has presence on MRI of microbleeds and areas of leptomeningeal hemosiderosis as per protocol 9.PT has presence of significant cerebral vascular pathology, or any cortical stroke regardless of age as assessed by the MRI central reader 10.PT is unable to tolerate MRI procedures or has a contraindication 11.PT has uncontrolled hypertension or has a history or presence of an abnormal ECG 12.PT has history of ventricular dysrhythmias or risk factors for ventricular dysrhythmias 13.PT has significant kidney disease as per protocol 14.PT has impaired hepatic function as per protocol 15.PT is positive for hepatitis B surface Ag, total hepatitis B core antibody, HIV-1 or -2 antibodies or antigen, or history of spirochetal infection of the CNS. PTs with a positive hepatitis C virus antibody will be allowed if hepatitis C RNA is negative 16.PTs with active or latent TB disease should not be enrolled in the trial 17. Any chronic active immune disorder requiring systemic immunosuppressive therapy within 1 year prior to study enrollment 18.PT has abnormal screening thyroid function tests 19.PT has screening folic acid or low vitamin B12 levels that may be contributing to cognitive impairment 20.PT has screening hemoglobin A1c >8% or poorly controlled insulin dependent diabetes 21.PT has deformity of the lumbosacral region of the spine that in the PI´s opinion would contraindicate LP in those who can only be CSF eligible due to regional lack of availability of PET ligands, or in those who are in Part 1 22.PT has clinically significantly abnormal screening blood or urine results that remain abnormal, or has impaired coagulation 23.PT has history of cancer except:a. Is clinically cured.b. Is not being actively treated and is not likely to require treatment in next 3 years.c. Low probability of recurrence d. Prostate cancer, without progression in the past 2 years 24.PT has known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins 25.PT with other severe or unstable medical condition that could put PT at special risk 26.PT resides in a skilled nursing facility, convalescent home, or long-term care facility 27.Takes any medications known to impair consciousness or cognit
排除标准
- •1.Participant (PT) has any evidence of a condition other than AD that may affect cognition 2.PT has history or presence of vascular disease that has the potential to affect cognitive function, or stroke within past 2 years, or ischemic attack within last 6 months 3.PT has history of severe, clinically significant CNS trauma, or history or presence of intracranial tumor, or presence of infections that affect brain function or history of infections with neurologic sequelae 4.PT has history or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits, or uveitis with medical intervention, chronic inflammatory or degenerative condition of the eye, current eye infection, any ongoing eye disorder requiring injectable medical therapy or planned invasive eye procedure during the study period 5.PT has history of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder, or is at risk of suicide in the PI´s opinion 6.PT has history of alcohol and/or substance use disorder within the past 2 years 7.PT has MRI evidence of a. >2 lacunar infarcts. b. Any territorial infarct >1 cm3. c. Any white matter lesion as per protocol 8.PT has presence on MRI of microbleeds and areas of leptomeningeal hemosiderosis as per protocol 9.PT has presence of significant cerebral vascular pathology, or any cortical stroke regardless of age as assessed by the MRI central reader 10.PT is unable to tolerate MRI procedures or has a contraindication 11.PT has uncontrolled hypertension or has a history or presence of an abnormal ECG 12.PT has history of ventricular dysrhythmias or risk factors for ventricular dysrhythmias 13.PT has significant kidney disease as per protocol 14.PT has impaired hepatic function as per protocol 15.PT is positive for hepatitis B surface Ag, total hepatitis B core antibody, HIV-1 or -2 antibodies or antigen, or history of spirochetal infection of the CNS. PTs with a positive hepatitis C virus antibody will be allowed if hepatitis C RNA is negative 16.PTs with active or latent TB disease should not be enrolled in the trial 17. Any chronic active immune disorder requiring systemic immunosuppressive therapy within 1 year prior to study enrollment 18.PT has abnormal screening thyroid function tests 19.PT has screening folic acid or low vitamin B12 levels that may be contributing to cognitive impairment 20.PT has screening hemoglobin A1c >8% or poorly controlled insulin dependent diabetes 21.PT has deformity of the lumbosacral region of the spine that in the PI´s opinion would contraindicate LP in those who can only be CSF eligible due to regional lack of availability of PET ligands, or in those who are in Part 1 22.PT has clinically significantly abnormal screening blood or urine results that remain abnormal, or has impaired coagulation 23.PT has history of cancer except:a. Is clinically cured.b. Is not being actively treated and is not likely to require treatment in next 3 years.c. Low probability of recurrence d. Prostate cancer, without progression in the past 2 years 24.PT has known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins 25.PT with other severe or unstable medical condition that could put PT at special risk 26.PT resides in a skilled nursing facility, convalescent home, or long-term care facility 27.Takes any medications known to impair consciousness
研究者
相似试验
进行中（未招募）
1 期
A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RECOMBINANT HUMAN PLASMA GELSOLIN (RHU-PGSN) ADDED TO STANDARD OF CARE FOR TREATMENT OF SUBJECTS WITH SEVERE COVID-19 PNEUMONIAsevere COVID-19 pneumoniaMedDRA version: 23.0Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862EUCTR2020-002460-31-ROBioAegis Therapeutics, Inc.60
进行中（未招募）
1 期
A Clinical Trial to evaluate AL002 in Participants with early Alzheimer's DiseaseEarly Alzheimer’s DiseaseMedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersEUCTR2019-001476-11-FRAlector Inc.265
进行中（未招募）
不适用
Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitisEUCTR2010-022766-27-BEPfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK128
进行中（未招募）
1 期
A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adultsacute uncomplicated seasonal influenzaMedDRA version: 19.0Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 100000004862MedDRA version: 19.0Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 100000004862MedDRA version: 19.0Level: LLTClassification code 10016790Term: FluSystem Organ Class: 100000004862EUCTR2016-000425-40-ESGenentech Inc.141
进行中（未招募）
1 期
A Clinical Trial to evaluate AL002 in Participants with early Alzheimer's DiseaseEarly Alzheimer’s DiseaseMedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersEUCTR2019-001476-11-DEAlector Inc.328