ISRCTN93682878已完成2 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
orth Bristol NHS Trust (UK)0 个研究点目标入组 261 人开始时间: 2013年9月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 261
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29226862 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34687634/ (added 26/10/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age =55 years
- •2. A Mini Mental State Examination (MMSE) score of 18-28 or Montreal Cognitive Assessment (MoCA) of 12-24
- •3. A modified Hachinski score (56) of 5 or less
- •4. A previous CT or MRI scan consistent with a diagnosis of AD
- •5. The presence of an informant who is willing to participate in the study
- •6. Capacity to consent for themselves as judged by a member of the research teamwith appropriate training and experience
排除标准
- •Patients will be excluded/ineligible if they have any of the following:
- •1. Receiving ACE-Inhibitors; AT1RAs, aliskiren or potassium sparing diuretics
- •2. Known intolerance to sartans
- •3. Medically unsuitable for, or unwilling to have, an MRI scan
- •4. Consistent baseline BP of <115/70 mmHg or >160/110 mmHg
- •5. A fall in BP on standing of >20/10 mmHg associated with clinically significant symptoms or a fall >30/15 mmHg
- •6. Previous cerebrovascular accident (CVA), with significant residual impairment (Transient Ischaemic Attack (TIA) is NOT an exclusion)
- •7. Hypertrophic cardiomyopathy; or significant aortic valve stenosis
- •8. Estimated creatinine clearance of < 30 mL/min/1.73m2, or previous severe renal impairment with a sartan or ACE inhibitor
- •9. Evidence of liver disease or significant LFT derangement (Aspartate transaminase (AST)/ Alkaline Phosphatase (AP/ALP)/ Bilirubin greater than 2 x upper limit of normal) in the previous 12 months
- •10. Primary neurodegenerative diseases or potential causes of dementia other than AD.
- •11. 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
- •12. 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
- •13. Participation in a previous CTIMP within 6 months of RADAR trial entry
- •14. Severe hippocampal atrophy as identified at baseline (or previous) MRI scan according to the Sheltens Scale
研究者
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