CTIS2023-506514-44-00进行中（未招募）1 期
A PLACEBO CONTROLLED, RANDOMIZED DOUBLE-BLIND PARALLEL GROUP 12-MONTH TRIAL OF FASUDIL FOR THE TREATMENT OF EARLY ALZHEIMER’S DISEASE (FEAD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Early AD, eg Stage 3 MCI or Stage 4 (mild AD dementia), A significant change on a validated AD amyloid or tau biomarker (as determined either by visual reading of amyloid PET scans using any of the approved ligands, or CSF Aß 1-42 levels or blood p-tau 217 cut-offs as determined by the clinical research laboratory)., A CDR Global rating of 0.5 or 1.0 and have an MRI scan within the past two years that has no findings inconsistent with AD, Capacity to give informed consent based on the clinical judgement of an experienced clinician, The participant needs to have a reliable study partner with regular contact (a combination of face-to-face visits and telephone contact is acceptable) who has sufficient interaction with the participant to provide meaningful input into rating scales, Age from 50 years., Fluency in Norwegian and evidence of adequate premorbid intellectual functioning, Capable of participating in all scheduled evaluations and complete all required tests, Female participants must be of non-childbearing potential or have a negative serum pregnancy test within 14 days of baseline assessments and agree to the use of effective birth control throughout their participation in the study
排除标准
- •Significant cerebrovascular disease, as indicated by clinical history, neurological examination, or on MRI (including cortical infarction or deep white matter or periventricular white matter hyperintensities with a Fazekas scale score of 3, Current clinically significant depression or other mental disorder likely to affect cognition or interfere with study participation, Recent (within 3 months) relevant medication changes. Participants must have been on stable anti-dementia (cholinesterase inhibitors or memantine) or anti-depressive medications for at least three months before the study, Participants using sedating drugs, if unavoidable, will be excluded from the study. However, short-acting sleep medications can be used if taken as recommended and if the participant has maintained stability on them for a minimum of 3 months prior to the start of the study, Participation in other drug trials, Currently ongoing life-threatening disease, such as metastatic cancer, advanced cardiovascular disease, advanced respiratory disease, terminal kidney disease, or advanced stages of infectious diseases, Any current or past neurological disease unrelated to Alzheimer's disease with cognitive sequelae, A QTc interval = 460 milliseconds for males or = 470 milliseconds for females will be considered abnormal during the ECG assessments, A history of cerebrovascular bleeding or severe bleeding of the digestive tract, lungs, nose or skin, Severe renal impairment (GFR <30) or serum creatinine or urea nitrogen values =3 times ULN at screening or baseline, Moderate to severe hepatic impairment. Serum alanine transaminase (ALT) or aspartate transaminase levels =3 times ULN at screening or baseline, Currently poorly controlled diabetes as indicated by HbA1c values >9, White blood cell (WBC) values <3.5 K/µl, History of paralytic ileus or current severe chronic constipation, Known allergy to fasudil or established systemic inflammatory disease or autoimmune disease., Clinically significant hypotension defined by blood pressure values <90/60 mmHg, regardless of the individual's sitting or standing position and associated with relevant clinical symptoms (e.g., tachycardia, dizziness, syncope)
研究者
相似试验
进行中（未招募）
不适用
A study to determine the effects of 8 week treatment with an oral drug called ZPL-3893787 in adult subjects with moderate to severe atopic dermatitis.Atopic Dermatitis (AD)MedDRA version: 18.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2014-005057-39-PLZiarco Pharma Ltd90
已完成
不适用
CLINICAL STUDY TO EVALUATE IMMUNITY MODULATING EFFECTS ON HEALTHY SUBJECTSCTRI/2020/09/027961Tenshi Kaizen Pvt Ltd India60
进行中（未招募）
1 期
A study to determine the effects of 8 week treatment with an oral drug called ZPL-3893787 in adult subjects with moderate to severe atopic dermatitis.EUCTR2014-005057-39-BEZiarco Pharma Ltd90
进行中（未招募）
不适用
A clinical trial of MABT5102A for the treatment of Alzheimer's DiseaseMedDRA version: 14.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Alzheimer's DiseaseEUCTR2010-021926-37-DEGenentech Inc450
进行中（未招募）
1 期
A study to determine the effects of 8 week treatment with an oral drug called ZPL-3893787 in adult subjects with moderate to severe atopic dermatitis.Atopic Dermatitis (AD)MedDRA version: 18.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858EUCTR2014-005057-39-GBZiarco Pharma Ltd98