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Clinical Trials/EUCTR2012-003641-15-GB
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.

Registry
who.int
Start Date
June 20, 2013
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
orth Bristol NHS Trust

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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