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Phase 4 Completed N=83 Randomized Quadruple-blind Prevention

Lithium As a Treatment to Prevent Impairment of Cognition in Elders

Source: ClinicalTrials.gov NCT03185208 ↗
Enrolled (actual)
83
Serious AEs
26.3%
Results posted
Sep 2025
Primary outcomePrimary: California Verbal Learning Test II — 6.9; 6.2; 6.46; 5.10 units on a scale — p=0.048
◆ Published Evidence
Emerging
6citations · ~6 / year
Low-Dose Lithium for Mild Cognitive Impairment: A Pilot Randomized Clinical Trial.
JAMA neurology · 2026 · Open access · Likely link

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.

Linked Publications (2)

  • Low-Dose Lithium for Mild Cognitive Impairment: A Pilot Randomized Clinical Trial.
    JAMA neurology · 2026 · 6 citations · Open access · Likely link
  • The LATTICE Study: Design of a pilot feasibility randomized controlled trial of lithium to delay cognitive decline in mild cognitive impairment.
    Alzheimer's & dementia (New York, N. Y.) · 2025 · 4 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-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)

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) and the linked publication. 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. Informational only — not medical advice.

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