CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Lithium Carbonate +1 moredrug
Likely dose
Lithium Carbonate 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02862210
NCT02862210Phase 2Completed
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Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia

Columbia University·interventional·Posted Aug 10, 2016·Updated Feb 3, 2025

In Brief

A Phase 2 clinical trial evaluating Lithium Carbonate and Placebo for Frontotemporal Dementia (FTD). Completed, enrolled 17 participants across 1 site.

Detailed Summary

Frontotemporal dementia (FTD) is a progressive neurodegenerative illness that affects the frontal and anterior temporal lobes of the brain. Changes in behavior, including agitation, aggression, and repetitive behaviors, are common symptoms in FTD. The investigators currently do not have good medications to treat these symptoms in FTD, and the medications the investigators use often have side effects. In this project, the investigators will test the use of low-dose lithium, compared to a placebo pill, for the treatment of behavioral symptoms in FTD. Lithium greatly reduces the behavioral symptoms of bipolar disorder, and many have found low-dose lithium to be well-tolerated in patients with dementia. Lithium appears to inhibit the creation of a protein involved in many cases of FTD called tau.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFrontotemporal Dementia (FTD)
CountriesUnited States
CollaboratorsAlzheimer's Drug Discovery Foundation

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 10, 2016
Enrollment StartJan 27, 2017
Primary CompletionNov 20, 2022
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 9.9 years ago

Interventions

Lithium Carbonatedrug

Lithium will be prescribed starting at 150 mg/day, with subsequent dose titration to 300, 450, and 600 mg/day as tolerated according to side effects and blood lithium level.

Placebodrug

Placebo will be prescribed starting at 1 pill per day, with subsequent dose titration to 2,3, and 4 pills per day as tolerated by sham blood lithium levels.