Can a common blood pressure drug, losartan, help in Alzheimer's disease?

Phase 1

• Conditions: Alzheimer's Disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-003641-15-GB
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-20
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 228

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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.
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified