EUCTR2012-003641-15-GB
Active, not recruiting
Phase 1
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 sites228 target enrollmentJune 20, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- orth Bristol NHS Trust
- Enrollment
- 228
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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