None listed
Conditions
Brief summary
Background: Statins are effective in treating dyslipidaemia in older adults, reducing the cardiovascular related morbidity – however their adverse effects are more common and harmful amongst older adults. Additionally, the impact on cognition is unclear, with previous studies producing mixed results. The N-of-1 method has been demonstrated to be a feasible method of conducting deprescribing trials, generating strong-patient specific evidence as to the effects of discontinuing statin use on cognition. Aims: 1. To determine the effect on cognition of discontinuation and rechallenge with statins. 2. To determine the effects on quality of life and functional status of discontinuation and rechallenge with statins. Methods: A pilot interventional study of 30 older adults 80 years of age or older admitted to Royal North Shore Hospital, Sydney with current dementia diagnosis, and taking statins for at least 6 months will be conducted. Participants will be randomly assigned to statin and placebo treatment pairs with discontinuation and rechallenge of statins over the course of 4-months. At baseline (0-weeks), recruited patients will be subsequently randomised into either continuation of active statin treatment or placebo replacement for a period of 5-weeks. Participants will be followed at 5-weeks (Visit 2), 10-weeks (Visit 3) and 15-weeks (Visit 4). At each visit, patients will be crossed over into opposing intervention, either continuation of active statin or placebo. The primary outcome will be measured using the cognitive portion of the Alzheimer’s Disease Assessment Score (ADAS-CoG), which assesses the level of cognitive impairment on a 30-point scale with a psychometric test. The patients’ general practitioners will be contacted two months after trial completion to ascertain whether patients had discontinued, lowered dose, or continued their statin medication. Hypothesis: We hypothesise that patients will have improved cognition and quality of life when on placebo compared to when on statins.
Interventions
Patients will be randomly assigned to one of two treatment arms: Arm 1, Placebo-Statin-Placebo; or Arm 2, Statin-Placebo-Statin.
Patients will be on each period of either 'statin' or 'placebo' for 5 weeks with no washout, resulting in a total trial period of 15 weeks.
Patients will be taking their normal statin treatment during their 'statin' period(s), with a placebo replacement during 'placebo' period(s).
Adherence will be tested by using a pill count at the end of each intervention period.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
80 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Mini-Mental State Examination (MMSE) score of between 10 and 23 and/or clinical diagnosis of dementia; currently taking any statin for at least 6 months
Exclusion criteria
Too unwell to participate, or in the terminal stage of any illness; active cancer diagnosis; taking a combination statin;
Outcome results
None listed