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.

Phase 3

• Conditions: Cognitive Dysfunction; Cognitive Impairment; Cognitive Decline; Hypertension; Cardiovascular - Hypertension; Neurological - Other neurological disorders

• Registration Number: ACTRN12621000121864
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-08
• Study Completion: 2022-05-25
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Inclusion Criteria:
•Age 50 to 70 years.
•DSM-V diagnosis of Minor Neurocognitive Disorder:
omodest 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.
ocognitive deficits are insufficient to interfere with daily activities, but that greater effort, compensatory strategies, or accommodation may be required to maintain independence.
ocognitive deficits do not occur exclusively in the context of a delirium.
ocognitive 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 Criteria

Exclusion Criteria:
•Taking an ACE-I that cannot be:
ostopped, or
oswitched to open label telmisartan 20-40mg, indapamide 1.25mg or 2.5mg, or amlodipine 2.5-5mg, or
oswitched 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified