RADAR Study

Principal Investigator:

Dr Bernadette McGuinness

 

Name of the Study:

Reducing Pathology in Alzheimer’s Disease Through Angiotensis Targeting.  The RADAR Trial.  A Phase II, Randomised, Double Blind, Placebo Control Trial To Evaluate the Effect of Losartan on Brain Tissue in Patients Diagnosed with Alzheimer’s Disease.

 

Why is this Study important?

To investigate whether 52 week treatment of Alzheimer’s Disease (AD) with the anti-hypertensive drug losartan has a beneficial effect on surrogate markers of disease progression.  Alzheimer’ s Disease is currently incurable and current therapies only treat symptoms for a limited time.  There is urgent need for better treatments to extend the quality of life in AD patients and their carers and reduce the rising costs to the NHS.   Epidemiology studies have consistently shown that hypertension in midlife, late life and stroke increase risk of dementia.

 

What is the research question/aim?

To investigate whether losartan reduces rates of Alzheimer’s Disease associated whole brain atrophy, improves levels of cerebral blood flow (CBF) and reduces levels of white matter hyperintensities (WMH) using sophisticated and industry standard MRI scanning and analysis.  Examine if losartan improves patient scores in standard cognitive assessments.  Examine the correlation between MRI measures of AD pathology and cognitive assessment scores following one year of losartan treatment.  Explore the tolerability and safety profile of losartan in elderly normotensive AD patients to inform phase III studies.  Explore the differences in brain atrophy rates and changes in cognitive measures, in relation to change in blood pressure levels in AD patients after AngII suppression.  Provide an archive of stored bloods from trail participants that can be subsequently investigated in more depth, if the trial is successful. (optional)

 

What the study involves:

A phase II, two arm double-blind, placebo-controlled, multi-centre, randomised trial comparing 100mg losartan or placebo effects on MRI brain imaging in AD patients following 12 months of treatment.  The randomised stage of the trial will commence after 3-4 week pre-study open-label phase.  This will involve potential participants being on active drug for 14 days and the 4-14 days washout on a placebo, to ensure all patients entering the trial can tolerate the 100mg dose of losartan.  After the open-label phase participants will undergo a baseline MRI protocol and cognitive assessment and will be randomised.

 

Visits:

Visit 1:  Screening Visit: (4 hours). One room. Consent, vital signs, blood samples, physical exam, ECG, cognitive assessment x1.

Visit 6: Baseline Visit: (6 hours in total - 4 hours for participant, 2 hours for carer). Two rooms. Vital signs, blood samples, cognitive assessment x5, drug dispensing.

Visit 12: End of Study: (6 hours in total – 4 hours for participant, 2 hours for carer).  Two rooms: Vital signs, physical exam, blood samples, cognitive assessments x6.

Unscheduled: 4 hours. One room. Consent, vital signs, blood samples, physical exam, ECG, cognitive assessment.

Early Termination: 6 hours in total – 4 hours for participant, 2 hours for carer.

 

PPI Involvement:

Not applicable.

 

Who can take part in the Study?

Participants with mild Alzheimer’s Disease, who will each be accompanied by their carer.

 

Contact Information:

Principal Investigator: Dr Bernadette McGuinness

Third Floor

Institute of Clinical Science

Centre Public Health

Royal Victoria Hospital Site

Grosvenor Road

Belfast

BT12 6BA

Email: b.mcguinness@qub.ac.uk

Tel:     028 9063 2638

 

 

 

Location:

NI Clinical Research Facility,

U Floor, Belfast City Hospital,

Lisburn Road, Belfast, BT9 7AB

 

Tel:+44 (0)28 9504 0342

Email:NICRF@belfastrust.hscni.net

 
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