Phase 4 N=83 Randomized Quadruple-blind Prevention

Lithium As a Treatment to Prevent Impairment of Cognition in Elders

Mild Cognitive Impairment

Bottom Line

View on ClinicalTrials.gov: NCT03185208 ↗

Enrolled (actual)

Serious AEs

26.3%

Results posted

Sep 2025

Primary outcome: Primary: California Verbal Learning Test II — 6.9; 6.2; 6.46; 5.10 units on a scale — p=0.048

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lithium Carbonate (Drug); Placebo oral capsule (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Ariel Gildengers, MD
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY California Verbal Learning Test II	6.9; 6.2; 6.46; 5.10	0.048 sig
PRIMARY Brief Visuospatial Memory Test - Revised	5.97; 5.9; 5.69; 6.19	0.78
PRIMARY Preclinical Alzheimer Cognitive Composite Composed of Memory and Other Cognitive Tests	0.10; 0.43; -0.67; -0.19	0.80
PRIMARY Glycogen Synthase Kinase-3 Beta (GSK-3β) Activity	—	—
PRIMARY Brain-derived Neurotrophic Factor	14.5; 14.1; 14.5; 14.3	0.93
PRIMARY Cerebral Cortical Gray Matter Volume	412951; 405236; 411270; 402212	0.78
PRIMARY Hippocampal Volume	7352; 7118; 7369; 6884	0.087
SECONDARY Cerebrospinal Fluid Phospho Tau Level (CSF)	—	—

Summary

Alzheimer's disease (AD) is the most common cause of dementia in adults 65 years and older. AD leads to a complete loss of memory and independent function, and presently there is no cure. Many studies suggest that lithium treatment may delay dementia onset or slow its progression. However, more research is needed to understand the extent of its anti-dementia properties if it will be deployed broadly in the general population. This study will examine whether lithium has anti-dementia properties in older adults who have mild cognitive impairment and are at risk of becoming demented.

Eligibility Criteria

Inclusion Criteria

60 years or older
Diagnosis of Mild Cognitive Impairment

Exclusion Criteria

Major psychiatric illness (mild psychiatric illness may be included)
Major neurologic illness (e.g., multiple sclerosis)
Contraindication to lithium (e.g., renal insufficiency)
Unable to complete neuropsychological testing due to non-remediable impairment (e.g., blindness)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03185208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.