Efficacy and safety of pioglitazone in improving cognitive function among patients with impaired cognition as an add on therapy- a study protocol.

Rationale Management strategy to improve cognition is one of the challenges faced by clinicians. Importantly, pioglitazone, a safe and cost-effective medication has been shown to improve memory dysfunction in both animal and some clinical studies Aim To assess and compare the effect of pioglitazone as an add-on therapy in treating cognitive decline in patients with Parkinson’s disease, stroke and dementia. Sample size estimates A sample size of 240 patients with parkinson’s disease, stroke and dementia (60 in each group) were calculated based on convenience sampling with a 5% significance, 80% power. Methods and design This is a randomised double blind controlled trial involving individuals with severe to mild cognitive impairment (MoCA score below 24) associated with either parkinson’s disease, stroke or dementia. All neurological conditions were clinically diagnosed based on the standard criterions. Participants were randomised 1:1 to orally take 15mg of pioglitazone once daily for 6 months. Study outcomes The primary outcome measure is the change in MoCA score at 6 months. Secondary outcome measures include the assessment of clinical manifestations, cognitive performance, normal neurological markers, adverse drug reactions and medication adherence over a follow- up period of 6 months and 12 months. Discussion The objective of this trial is to evaluate the efficacy of Pioglitazone in improving cognitive dysfunction associated with parkinson’s disease, stroke and dementia. Additionally, the trial gives insights onto the safety of the medication in these conditions.