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NCT02862210 · ClinicalTrials.gov registry record · Phase 2
Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT02862210: Completed Phase 2 study, sponsored by Columbia University.
NCT02862210 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02862210, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
The NPI is a scale designed to assess behavioral changes due to neurological illness. It uses a standardized caregiver interview to rate patient symptoms in a variety of domains, including "Agitation/Aggression." Each domain includes a number of questions about potential specific symptoms, and then asks the caregiver to rate symptom frequency (1, occasionally, to 4, very frequently) as well as symptom severity (1, mild, to 3, severe). Scores range from from 0-12, with 0 being no symptoms and 12
Interventions
- DRUG Placebo
- DRUG Lithium Carbonate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-01-27 |
| Est. Completion | 2022-11-20 |
| Phase | Phase 2 |
What the finished NCT02862210 record still lists
NCT02862210 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02862210 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02862210 about?
NCT02862210 is a clinical study titled "Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia". 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 medicat...
What is the current status of trial NCT02862210?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2017-01-27. Estimated completion is 2022-11-20.
What interventions are being tested in trial NCT02862210?
The interventions under investigation include: Placebo (DRUG), Lithium Carbonate (DRUG).
Who is sponsoring clinical trial NCT02862210?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02862210's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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