Reid ENVIS‐ion 2012.

Study name	Aspirin for the prevention of cognitive decline in the elderly: rationale and design of a neurovascular imaging study (ENVIS‐ion) Substudy of: Aspirin in Reducing Events in the Elderly (ASPREE)
Methods	Double‐blind, placebo‐controlled trial of 3 years' duration set in 2 Australian academic medical centre outpatient clinics
Participants	600 adults aged ≥ 70 years with normal cognitive function and without overt cardiovascular disease
Interventions	Aspirin 100 mg daily Placebo
Outcomes	Primary outcome Death from any cause or incident, dementia or persistent physical disability (every 6 months) Secondary outcomes All‐cause mortality (every 6 months) Fatal and non‐fatal cardiovascular events including: death due to coronary heart disease, non‐fatal myocardial infarction, fatal and non‐fatal stroke and any hospitalisation for heart failure (every 6 months) Fatal and non‐fatal cancer, excluding non‐melanoma skin cancer (every 6 months) Dementia (every 6 months) Mild cognitive impairment (assessed using Modified MMSE and other cognitive function measures) (every 6 months) Physical disability (every 6 months) Major haemorrhagic events (every 6 months) Depression (annually)
Starting date	January 2010
Contact information	Principal Investigators: Richard Grimm, MD, PHD: Berman Center for Outcomes and Clinical Research, Minneapolis, MN, US; John McNeil, MBBS, PHD: Monash University; Berman Center for Outcomes & Clinical Research; ASPREE Project Manager, Brenda Kirpach Contact number: 612‐873‐6905 Contact email: bkirpach@bermancenter.org
Notes	Clinicaltrial.gov: NCT01038583 Study protocol: www.ncbi.nlm.nih.gov/pmc/articles/PMC3297524/

ADAS‐Cog‐11: 11‐item Alzheimer's Disease Assessment Scale – Cognitive Subscale; ALT: alanine aminotransferase; AST: aspartate transaminase; CHADS: Congestive heart failure, Hypertension, Age ≥ 75 years, Diabetes mellitus, previous Stroke/transient ischaemic attack; CrCl: creatinine clearance; CSF: cerebrospinal fluid; DAD: Disability Assessment for Dementia; INR: international normalised ratio; MMSE: Mini‐Mental State Examination; MRI: magnetic resonance imaging; NINDS‐CSN: National Institute of Neurological Disorders and Stroke – Canadian Stroke Network; TIA: transient ischaemic attack; VCI: vascular cognitive impairment; WMC: white matter change; WMH: white matter hyperintensity.