EUCTR2012-003641-15-GB进行中（未招募）1 期
Reducing pathology in Alzheimer’s Disease through Angiotensin taRgeting. The RADAR Trial. A phase II, two arm, double-blind, placebo-controlled, randomised trial to evaluate the effect of losartan on brain tissue changes in patients diagnosed with Alzheimer’s disease. - The RADAR trial in Alzheimer's disease.
orth Bristol NHS Trust0 个研究点目标入组 228 人开始时间: 2013年6月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 228
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
- •Age=55 years
- •A MMSE score of 15-28 (equivalent to a previous Montreal Cognitive Assessment (MoCA) of 7-26). NB all patients must undergo an MMSE as part of their eligibility assessment for RADAR, but may be screened on the basis of a previous MMSE/MoCA score.
- •A modified Hachinski score of 5 or less
- •A previous CT or MRI scan consistent with a diagnosis of AD
- •The presence of an informant who is willing to participate in the study
- •Capacity to consent for themselves as judged by a member of the research team with appropriate training and experience
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Receiving ACE-Inhibitors; AT1RAs, aliskiren or potassium sparing diuretics
- •Known intolerance or renal problems with ACE-inhibitors or sartans
- •Medically unsuitable for, or unwilling to have, an MRI scan
- •Consistent baseline BP of <115/70 mmHg or >160/110 mmHg
- •A fall in BP on standing of >20/10 mmHg associated with clinically significant symptoms or a fall >30/15 mmHg
- •Previous cerebrovascular accident (CVA), with significant residual impairment (Transient Ischaemic Attack (TIA) is NOT an exclusion)
- •Hypertrophic cardiomyopathy; or significant aortic valve stenosis
- •Estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73m2Evidence of liver disease or significant LFT derangement (Aspartate transaminase (AST)/ Alkaline Phosphatase (AP/ALP)/ Bilirubin greater than 2 x upper limit of normal)
- •Potassium (K) greater than 6 on non-haemolysed sample
- •Primary neurodegenerative diseases or potential causes of dementia other than AD.
- •Females who have not yet reached the menopause (defined as having a period in the previous 12 months) who test positive for pregnancy, are unwilling to take a pregnancy test prior to trial entry, or are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial
- •Any severe co-incident medical disease, or other factor inhibiting compliance with the study medication or follow up schedule e.g. participant unlikely to survive the trial follow up period due to a terminal comorbid condition
- •Participation in a previous CTIMP within 6 months of RADAR trial entry
研究者
相似试验
已完成
不适用
The prevention of Alzheimer's disease through regulation of amyloid beta synthesis and brake-down by propolis intaketype 2 diabetes dementiaJPRN-UMIN000015423Kyoto Prefectural University of Medicine, Graduate School of Medical Science60
已完成
2 期
Reducing pathology in Alzheimer's disease through angiotensin targetingTopic: Dementias and Neurodegenerative Diseases Research NetworkSubtopic: DementiaDisease: DementiaNervous System DiseasesAlzheimer disease, unspecifiedISRCTN93682878orth Bristol NHS Trust (UK)261
招募中
Unknown
Dementia treatment with combination of hydrogen gas and reduced dose lithium.Alzheimer's dementiaJPRN-jRCT1091220303Hirohisa Ono50
招募中
不适用
Establishment of dementia onset and progression model considering relevant high-risk genes after COVID-19 infection in dementia high-risk groupMental and behavioural disordersKCT0007688The Catholic University of Korea, Seoul St. Mary's Hospital65
尚未招募
不适用
The care system for Alzheimer's patient to supervise administration with bidirectional IT communicationsAlzheimer's dementiaJPRN-UMIN000006542Department of Human Health Sciences, Graduate School of Medicine, Kyoto University30