Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000555651
Ethics application status
Approved
Date submitted
12/05/2023
Date registered
24/05/2023
Date last updated
30/06/2023
Date data sharing statement initially provided
24/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of REducing Cognitive decline and dementiA by Lowering bLood pressure Pilot (RECALL Pilot)
Scientific title
The feasibility of REducing Cognitive decline and dementiA by Lowering bLood pressure in healthy adults aged 70 years and over Pilot (RECALL Pilot)
Secondary ID [1] 309139 0
None
Universal Trial Number (UTN)
Trial acronym
RECALL-Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 329237 0
mild cognitive impairment 329238 0
cardiovascular disease 329239 0
hypertension 330060 0
Condition category
Condition code
Neurological 326196 326196 0 0
Dementias
Cardiovascular 326197 326197 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325587 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334073 0
Feasibility of recruitment - percentage of eligible participants recruited from listed generated by GP practices. Time and speed of recruitment from community assessed in recruitment logs.
Timepoint [1] 334073 0
Recruitment assessed at conclusion of 6 month study period.
Secondary outcome [1] 419278 0
Adherence to medication assessed using pill count.
Timepoint [1] 419278 0
Assessed for each participant at study end using pill count.
Secondary outcome [2] 419279 0
Safety assessed by blood tests measuring Urea, Creatinine, Sodium and Potassium .
Timepoint [2] 419279 0
Assessed by blood tests measuring Urea, Creatinine, Sodium, Potassium after at least 1 month on medication.
Secondary outcome [3] 422119 0
Scoring on series of online cognitive testing procedures from Creyos Health.
Timepoint [3] 422119 0
At end of study duration.

Eligibility
Key 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
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Logistics and feasibility: simple descriptive statistics and tests (proportions, means, chi-squared, t-tests) will be used to describe recruitment rates and differences in the characteristics of participants and the general population. Statistical models will be used to estimate the likely outcome rates (CV events and mortality) in a large phase III study, based on the characteristics of those recruited.

To describe the effects on BP and biochemistry/renal function: We will use descriptive statistics (means, medians, ranges, and their 95%CIs) to describe the baseline, end of run-in phase, and at 3-months follow-up. If the data are skewed, we will use the log scale and calculate geometric means (with 95% CIs) to estimate differences.

To identify the characteristics of people whose are more susceptible to dropping out of the study: We will use data from a nested process evaluation to inform the quality of our systems.

Descriptive results of recruitment speed and adherence of IMP will be provided. Recruitment figures will be generated weekly plus cumulative recruitment speed, comparing with expected recruitment number within 6 months. Proportion of adherence to IMP will be generated at the end of follow-up and adequate adherence (>=80% of adherence to IMP) will be assessed. Blood pressure measurements over time and other patient characteristics will be analysed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
Date of last participant enrolment
Anticipated
3/01/2024
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313341 0
Other Collaborative groups
Name [1] 313341 0
The George Institute for Global Health
Country [1] 313341 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
Level 5, 1 King Street, Newtown NSW 2042
Country
Australia
Secondary sponsor category [1] 315087 0
None
Name [1] 315087 0
Address [1] 315087 0
Country [1] 315087 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312563 0
Sydney Local Health District HREC – RPA
Ethics committee address [1] 312563 0
Ethics committee country [1] 312563 0
Australia
Date submitted for ethics approval [1] 312563 0
23/03/2023
Approval date [1] 312563 0
Ethics approval number [1] 312563 0
Ethics committee name [2] 313323 0
Royal Prince Alfred Hospital Ethics Committee
Ethics committee address [2] 313323 0
Ethics committee country [2] 313323 0
Australia
Date submitted for ethics approval [2] 313323 0
24/03/2023
Approval date [2] 313323 0
25/05/2023
Ethics approval number [2] 313323 0
2022/ETH02097

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125102 0
Prof Craig Anderson
Address 125102 0
The George Institute for Global Health, Level 5, 1 King Street, Newtown NSW 2042
Country 125102 0
Australia
Phone 125102 0
+61 410 476 311
Fax 125102 0
Email 125102 0
[email protected]
Contact person for public queries
Name 125103 0
Ruth Peters
Address 125103 0
The George Institute for Global Health, Level 5, 1 King Street, Newtown NSW 2042
Country 125103 0
Australia
Phone 125103 0
+61 2 8052 4300
Fax 125103 0
Email 125103 0
[email protected]
Contact person for scientific queries
Name 125104 0
Ruth Peters
Address 125104 0
The George Institute for Global Health, Level 5, 1 King Street, Newtown NSW 2042
Country 125104 0
Australia
Phone 125104 0
+61 2 8052 4300
Fax 125104 0
Email 125104 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared as this is a Pilot/ feasibility study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18517Informed consent form    385511-(Uploaded-18-05-2023-14-58-50)-Study-related document.docx
19146Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.