None listed
Conditions
Brief summary
RECALL-Pilot is a prospective, decentralised pilot trial to investigate the feasibility of using a blood pressure lowering ‘polypill’ including telmisartan 20mg, amlodipine 2.5mg, indapamide 1.25mg in a decentralised trial to prevent ‘significant cognitive impairment’ (MCI or dementia).
Interventions
Treatment will be with GMRx2 once daily- a combination of 3 antihypertensive agents in a single pill with 4-weeks of a ½ dose (i.e. telmisartan 10mg, amlodipine 1.25mg, indapamide 0.625mg), followed by 4-weeks of the full dose (i.e. telmisartan 20mg, amlodipine 2.5mg, indapamide 1.25mg). Participants will be asked to self-report remaining medication and offered to return medication.
Sponsors
The George Institute for Global Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults (age greater than or equal to 70 years) 2. Proficient in English (able to provide informed consent) 3. Participants cannot be taking any ACE Inhibitors, spironolactone, eplerenone, amiloride, or triamterene or the medications contained the in the trial treatment at a dose that would mean taking the trial treatment resulted in a more than maximum dose of angiotensin receptor blockers, thiazide like diuretics or dihydropyridine calcium channel blockers nor any medication contraindicated for the trial treatment. 4. Participants cannot be taking 2 or more antihypertensive medications of any class. 5. A measure of systolic BP >110 mmHg taken in the previous one-month via home blood pressure monitor, in pharmacy or by clinician; 6. Two valid contact details – a. the participant (home address, mobile and email), b. GP or Medical Centre (name, address and phone number). 7. Satisfactory completion of online cognitive testing (3 cognitive tests) that meet the software (CREYOS) providers validity indicator to show the test was attempted. Participants must also score above the study threshold (higher scores indicate better performance) on 2 of the 3 tests on at least one of two occasions (i.e. participants are allowed up to 2 attempts at the 3 cognitive tests). If participants score above the threshold on their first attempt an additional attempt will not be offered. The study threshold is set at 1 standard deviation below the mean. 8. Agree to take trial medication for a total of: ½ dose of GMRx2 for 30 days, followed by the full dose of GMRx2 for 30 days (i.e. 60 days total duration). 9. Agrees to complete online assessments before the study start, during and at the end of the pilot trial. 10. Agrees to nominating a ‘study buddy’ for the study, and obtaining the study buddy’s consent for investigators to contact them if required. 11. Willingness to have two blood tests as part of the study
Exclusion criteria
1. A reported diagnosis of Dementia 2. Current treatment with anti-dementia medication 3. Cognitive test scores below acceptable threshold after two assessments. 4. Participants who report having a serious health condition that would compromise their ability to adhere to all of the study procedures 5. Reports symptomatic low BP 6. Current treatment with excluded or contraindicated medication 7. Are unable to provide contact details and GP details 8. Participating in another Investigational Medicinal Product Trial that conflicts with RECALL-Pilot 9. Unable to provide written informed e-consent. 10. Unable to complete online forms
Outcome results
None listed