The feasibility of REducing Cognitive decline and dementiA by Lowering bLood pressure in healthy adults aged 70 years and over Pilot (RECALL Pilot)

The George Institute for Global Health0 sites300 target enrollmentMay 24, 2023

Conditionsdementia mild cognitive impairment cardiovascular disease hypertension Neurological - Dementias Cardiovascular - Hypertension

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: dementia
Sponsor: The George Institute for Global Health
Enrollment: 300
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 24, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

The George Institute for Global Health

Eligibility Criteria

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).

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