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Mood Stabilizer

Lithium Carbonate for Frontotemporal Dementia (Lithium Trial)

Phase 2
Waitlist Available
Led By Edward Huey, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Lithium Trial Summary

This trial will test whether low-dose lithium can improve behavioral symptoms in people with frontotemporal dementia.

Eligible Conditions
  • Frontotemporal Dementia

Lithium Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in agitation and aggression as measured by the Neuropsychiatric Inventory Scale (NPI)
Secondary outcome measures
Proportion of responders in the lithium and placebo groups
Other outcome measures
Change in motor symptoms as measured by the NPI
Presence of adverse events as measured by the Treatment Emergent Symptoms Scale (TESS)
The relationship between changes in brain-derived neurotropic factor (BDNF) serum levels and changes in NPI "Agitation/Aggression" score and "Aberrant Motor Behavior" score

Lithium Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lithium carbonateExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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 provided by an unblinded study team member.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lithium carbonate
FDA approved

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,429 Previous Clinical Trials
2,460,135 Total Patients Enrolled
2 Trials studying Frontotemporal Dementia
35 Patients Enrolled for Frontotemporal Dementia
Alzheimer's Drug Discovery FoundationOTHER
21 Previous Clinical Trials
3,124 Total Patients Enrolled
3 Trials studying Frontotemporal Dementia
190 Patients Enrolled for Frontotemporal Dementia
Edward Huey, MDPrincipal InvestigatorBrown University
3 Previous Clinical Trials
285 Total Patients Enrolled
2 Trials studying Frontotemporal Dementia
35 Patients Enrolled for Frontotemporal Dementia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this trial?

"Affirmative. Clinicaltrials.gov details that this experimental trial, which was first introduced on January 27th 2017, is currently enrolling patients. To fulfil the needs of the study, 60 volunteers need to be recruited at two different medical sites."

Answered by AI

Is this study accepting participants aged above 20?

"Interested participants must be in the range of 40 to 85 years old, as detailed by this study's selection requirements. There are 42 clinical trials available for those under 18 and 436 studies catered towards patients over 65."

Answered by AI

Does this research endeavor have any open slots for participants?

"Clinicaltrials.gov states that this medical study is actively enrolling participants, with the first posting on January 27th 2017 and a recent update occurring November 7th 2022."

Answered by AI

Has the FDA sanctioned Lithium Carbonate for treatment?

"Taking into account the Phase 2 trial status, our team at Power assigned Lithium Carbonate a safety rating of 2 out of 3. This is because there are some reports confirming its security but none that suggest it brings about any beneficial effects."

Answered by AI

Am I eligible for participation in this research study?

"This medical trial seeks 60 individuals aged between 40 and 85 who are displaying behavioural symptoms. To meet the criteria, they must have a study partner to provide information during interviews, possess Structural MRI or CT scan after symptom onset, be diagnosed with bv-FTD/sv-PPA/nfv-PPA (generally accompanied by behavioural syndrome), score 5 - 26 on Folstein Mini Mental State Examination, exhibit capacity for consent or appoint a surrogate, show moderate to severe NPI agitation/aggression subscale scores higher than 4."

Answered by AI
~2 spots leftby Apr 2025