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Intranasal insulin therapy does not deliver significant cognitive, functional, or biomarker benefits in mild cognitive impairment or mild-to-moderate Alzheimer’s disease.
A growing body of research has linked central insulin resistance to Alzheimer’s disease (AD) development, giving rise to the concept of AD as a possible form of “type 3 diabetes.” Based on this hypothesis, intranasal insulin has been explored as a novel, non-invasive strategy to enhance brain insulin signaling while avoiding systemic metabolic side effects.
However, new evidence suggests that this approach may not deliver meaningful clinical benefits. Researchers conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to monitor the efficiency and safety of intranasal insulin in patients with mild cognitive impairment (MCI) or mild-to-moderate AD.
The analysis encompassed studies comparing intranasal insulin with placebo, with a focus on both cognitive and functional outcomes, as well as biomarker changes. The literature search covered Embase. PubMed, and the Cochrane Central Register of Controlled Trials (CENTRAL) through April 2025. Outcomes were pooled via random-effects models, and study quality was assessed via the Cochrane Risk of Bias 2 tool.
Primary endpoints included:
Secondary endpoints included:
Overall, 5 RCTs involving 540 subjects fulfilled the inclusion criteria. Across pooled analyses, intranasal insulin did not demonstrate a statistically significant advantage over placebo for any major cognitive or functional outcome:
Similarly, intranasal insulin did not considerably alter CSF biomarkers, including Aβ42, total tau, or phosphorylated tau, suggesting no detectable impact on core AD pathology. From a safety perspective, intranasal insulin was generally well-tolerated, but some differences emerged:
This study challenges the growing interest in intranasal insulin as a treatment for AD, showing no meaningful improvement in cognition, daily functioning, or key biomarkers among patients with MCI or mild-to-moderate AD.
Revue Neurologique
Intranasal insulin for mild cognitive impairment and Alzheimer's disease: A systematic review and meta-analysis of randomized controlled trials
A M P Silva et al.
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