Action To promote brain HEalth iN Adults (ATHENA) trial: a pilot feasibility study to determine the effects of blood pressure lowering treatment provided by a Triple Pill strategy for attenuation of cognitive decline in participants at risk for dementia.
An investigator initiated and conducted study to determine the feasibility of online and telephone recruitment, videoconference-delivered neuropsychological assessments, and mailed trial medication and self-monitored blood pressure (BP) measures for a double-blinded, placebo-controlled, randomised controlled trial to determine the effects of BP lowering provided by a fixed low-dose combination antihypertensive pill strategy on top of standard of care, on cognitive decline in participants at risk for dementia (ATHENA Pilot).
The George Institute for Global Health
200 participants
Dec 17, 2021
Interventional
Conditions
Summary
The Action To promote brain HEalth iN Adults (ATHENA) pilot trial uses an RCT design and involves treatment with a low-dose triple combination pill of BP lowering agents or placebos. ATHENA will evaluate the feasibility, applicability, tolerability, safety and adherence of a risk reduction approach in a high-risk target population, evaluating a BP lowering intervention. In the current study, we will also test the feasibility of recruitment and assessment of a population with higher than average risk of dementia (i.e. DSM-V diagnosis of Minor Neurocognitive Disorder) remotely. The screening will be made through online assessments with subsequent telephone calls to assess eligibility and videoconference neuropsychological assessments.
Eligibility
Inclusion Criteria8
- Age 50 to 70 years.
- DSM-V diagnosis of Minor Neurocognitive Disorder:
- o modest cognitive decline from a previous level of performance in at least one domain, based on the concerns of the individual, a knowledgeable informant or the clinician; and a decline in neurocognitive performance of >1 standard deviation below appropriate norms on formal testing or equivalent clinical evaluation.
- o cognitive deficits are insufficient to interfere with daily activities, but that greater effort, compensatory strategies, or accommodation may be required to maintain independence.
- o cognitive deficits do not occur exclusively in the context of a delirium.
- o cognitive deficits are not primarily attributable to another mental disorder (for example major depressive disorder and schizophrenia).
- An additional enrichment factor indicating elevated risk for declining cognition, defined as one or more of self-reported: monotherapy treatment of hypertension, diabetes mellitus, elevated low-density lipoprotein cholesterol, obesity, current smoking, or first degree relative with dementia.
- Provision of online, verbal and electronic informed consent.
Exclusion Criteria15
- Taking an ACE-I that cannot be:
- o stopped, or
- o switched to open label telmisartan 20-40mg, indapamide 1.25mg or 2.5mg, or amlodipine 2.5-5mg, or
- o switched to a beta blocker
- Contraindication to any of the study medications, in the context of BP lowering medication currently prescribed by primary care physicians (e.g. those who are on regular NSAID prescription/consumption).
- Unable to complete the study procedures and/or follow-up.
- Significant abnormal kalaemia and/or natraemia, in the opinion of the responsible physician.
- Stage 3b renal failure (GFR < 45 ml/min/1.73m2).
- Severe liver disease (e.g. acute viral hepatitis, chronic active hepatitis, cirrhosis).
- Severe hepatic impairment (ALT or AST) >3x the upper limit of normal [ULN]).
- Pre-existing dementia, another neurodegenerative disease (e.g. Huntington’s, multiple sclerosis, Parkinson’s disease), cognitive decline due to substance use (measured on the World Health Organisation Alcohol Use Disorders Identification Test (WHO-AUDIT)), severe mental ill-health, or neurological or systemic disorder.
- Montreal Cognitive Assessment (MoCA) score <18.
- History of stroke within the last 6 months and/or history of stroke with any residual deficit.
- History of traumatic brain injury with loss of consciousness within the last 2 years.
- No ongoing serious medical or psychiatric cognition that would prevent full participation.
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Interventions
Triple Pill (active treatment) - telmisartan 20mg, amlodipine 2.5mg and indapamide 1.25mg: taken orally once daily for 4 weeks. Medication adherence: At the end of study, returned capsules will be counted and recorded by the study team. Additionally, participants will be provided with contact details of the responsible researcher so that they can make contact if for any reason they are unable to continue their study medication or have missed multiple doses and are unsure whether to continue. Standard of care for participants is monotherapy with any blood pressure lowering medication and GP management. Screening will involve the following: Initial Online assessment: estimated 30 minutes Telephone assessment: (Screening) estimated 40 minutes First videoconference-(Consent and eligibility) estimated 40 minutes Second videoconference: (Cognitive testing) estimated 90 minutes At this point if the participant is eligible they will be randomised
Locations(1)
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ACTRN12621000121864