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Low-Dose Lithium for Mild Cognitive Impairment: A Pilot Randomized Clinical Trial.

Ariel G Gildengers1, Tamer S Ibrahim2, Stewart J Anderson3

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|March 2, 2026
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Summary

This pilot study found low-dose lithium carbonate feasible and safe for mild cognitive impairment (MCI). While not meeting significance, lithium showed a trend toward slowing cognitive decline in MCI patients.

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Area of Science:

  • Neuroscience
  • Gerontology
  • Pharmacology

Background:

  • Lithium deficiency is implicated in Alzheimer's disease pathogenesis.
  • No prior randomized clinical trials have investigated lithium's impact on cognition, neuroimaging, and plasma biomarkers in mild cognitive impairment (MCI).

Purpose of the Study:

  • To assess the feasibility, safety, and preliminary efficacy of lithium carbonate in delaying cognitive decline among older adults diagnosed with MCI.
  • To establish effect size estimates for future research on low-dose lithium interventions for MCI.

Main Methods:

  • A single-site, randomized, double-blind, placebo-controlled pilot feasibility trial involving 83 adults (aged 60+) with MCI.
  • Participants received daily low-dose lithium carbonate or placebo for two years, with follow-up analyses using linear mixed-effects models.
  • Six coprimary outcomes included cognitive performance (CVLT-II, BVMT-R, preclinical Alzheimer cognitive composite), hippocampal volume, cortical gray matter volume, and brain-derived neurotrophic factor.

Main Results:

  • None of the six coprimary outcomes reached statistical significance.
  • A trend suggested lithium may slow cognitive decline, with a 0.69 points/year difference in CVLT-II delayed recall compared to placebo (P=.05).
  • Adverse events were similar between groups; no serious events were definitively treatment-related.

Conclusions:

  • The pilot trial demonstrated that low-dose lithium carbonate is feasible, safe, and tolerable for individuals with MCI.
  • While not statistically significant, the study provides valuable effect size estimates and suggests a potential benefit for lithium in slowing cognitive decline, warranting further investigation.