Trial · NCT02862210
Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia
NCT02862210, Phase 2, Completed, Columbia University; results first posted 2025-02-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia. Trials, record NCT02862210. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02862210
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia
- NCT number
- NCT02862210
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Frontotemporal Dementia (FTD)
- Interventions
- Lithium Carbonate, Placebo
- First posted
- 2016-08-10
- Last updated
- 2025-02-03
- Results first posted
- 2025-02-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Agitation and Aggression as Measured by the Neuropsychiatric Inventory Scale (NPI) | 12 weeks | 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 being very frequent and severe symptoms. The study aims to test the effect of lithium on agitation/aggression as compared to placebo by testing whether participants taking lithium show a greater reduction in their NPI "Agitation/Aggression" domain score over the course of the trial. |
| Secondary | Number of Responders in the Lithium and Placebo Groups | 12 weeks | Responder defined as a 30% decrease in NPI core score (sum of domain scores for "Agitation/Aggression" and "Aberrant Motor Behavior") plus a Clinical Global Impression (CGI) Change score of much improved or very much improved (CGI based on these behavioral symptoms only). |
| Other | Change in Motor Symptoms as Measured by the NPI | 12 weeks | NPI domain "Aberrant Motor Behaviors" will be observed to test the effect of lithium on repetitive behaviors as compared to placebo, by examining whether participants taking lithium show a greater reduction in their "Aberrant Motor Behaviors" NPI domain score. Scores range from from 0-12, with 0 being no symptoms and 12 being very frequent and severe symptoms. |
| Other | Presence of Adverse Events as Measured by the Treatment Emergent Symptoms Scale (TESS) | 12 weeks | The tolerability of low-dose lithium by assessing emergent side effects over the course of the 12-week trial will be assessed. The side effects will be captured with TESS in which 30 symptoms are rated either "Absent," "Mild," "Moderate," or "Severe." The change in TESS score from baseline to week 12 will be observed. Total scores range from 0 to 96 with a higher score indicating a worse outcome. |
| Other | The Relationship Between Changes in Brain-derived Neurotropic Factor (BDNF) Serum Levels and Changes in NPI "Agitation/Aggression" Score | Baseline and 12 weeks | The baseline serum BDNF levels as a potential baseline predictor of lithium treatment response and an increase from pre to post-treatment BDNF levels as a potential biomarker correlate of improvement in symptoms (as measured by the NPI) will be explored. The mean change of NPI "Agitation/Aggression" score as a function of BDNF level change from baseline to 12 weeks will be reported. Scores range from from 0-12, with 0 being no symptoms and 12 being very frequent and severe symptoms. |
| Other | The Relationship Between Changes in Brain-derived Neurotropic Factor (BDNF) Serum Levels and Changes in NPI "Aberrant Motor Behavior" Score | Baseline and 12 weeks | The baseline serum BDNF levels as a potential baseline predictor of lithium treatment response and an increase from pre to post-treatment BDNF levels as a potential biomarker correlate of improvement in symptoms (as measured by the NPI) will be explored. Aberrant motor behavior is characterized by repetitive movements and inability to sit still. The mean change of NPI Aberrant Motor Behavior score as a function of BDNF level change from baseline to 12 weeks will be reported. Scores range from from 0-12, with 0 being no symptoms and 12 being very frequent and severe symptoms. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Agitation and Aggression as Measured by the Neuropsychiatric Inventory Scale (NPI) | 12 weeks | score on a scale | MEAN | |
| SECONDARY | Number of Responders in the Lithium and Placebo Groups | 12 weeks | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Change in Motor Symptoms as Measured by the NPI | 12 weeks | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Presence of Adverse Events as Measured by the Treatment Emergent Symptoms Scale (TESS) | 12 weeks | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | The Relationship Between Changes in Brain-derived Neurotropic Factor (BDNF) Serum Levels and Changes in NPI Agitation/Aggression Score | Baseline and 12 weeks | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | The Relationship Between Changes in Brain-derived Neurotropic Factor (BDNF) Serum Levels and Changes in NPI Aberrant Motor Behavior Score | Baseline and 12 weeks | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Agitation and Aggression as Measured by the Neuropsychiatric Inventory Scale (NPI) | Lithium Carbonate | 7.14 | Standard Error 1.1 | score on a scale | |
| Change in Agitation and Aggression as Measured by the Neuropsychiatric Inventory Scale (NPI) | Placebo | 5.75 | Standard Error 1.28 | score on a scale | |
| Number of Responders in the Lithium and Placebo Groups | Lithium Carbonate | 0 | participants | ||
| Number of Responders in the Lithium and Placebo Groups | Placebo | 0 | participants | ||
| Change in Motor Symptoms as Measured by the NPI | Lithium Carbonate | 6.83 | Standard Error 0.95 | score on a scale | |
| Change in Motor Symptoms as Measured by the NPI | Placebo | 8.8 | Standard Error 1.23 | score on a scale | |
| Presence of Adverse Events as Measured by the Treatment Emergent Symptoms Scale (TESS) | Lithium Carbonate | 31.1 | Standard Error 0.55 | score on a scale | |
| Presence of Adverse Events as Measured by the Treatment Emergent Symptoms Scale (TESS) | Placebo | 31 | Standard Error 0.66 | score on a scale | |
| The Relationship Between Changes in Brain-derived Neurotropic Factor (BDNF) Serum Levels and Changes in NPI Agitation/Aggression Score | Lithium Carbonate | 0.71 | Standard Error 1.91 | score on a scale | |
| The Relationship Between Changes in Brain-derived Neurotropic Factor (BDNF) Serum Levels and Changes in NPI Agitation/Aggression Score | Placebo | -1.6 | Standard Error 2.11 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lithium Carbonate | 9 | |
| Overall Study | STARTED | Placebo | 7 | |
| Overall Study | COMPLETED | Lithium Carbonate | 9 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Lithium Carbonate | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Fall | Injury, poisoning and procedural complications | Lithium Carbonate | 2 | 9 | 2 |
| serious | Fall | Injury, poisoning and procedural complications | Placebo | 0 | 7 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lithium Carbonate | 0 | 9 |
| Total, all-cause mortality | Placebo | 0 | 7 |
| Total, other adverse events | Lithium Carbonate | 0 | 9 |
| Total, other adverse events | Placebo | 0 | 7 |
| Total, serious adverse events | Lithium Carbonate | 2 | 9 |
| Total, serious adverse events | Placebo | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lithium Carbonate vs Placebo: Number of Responders in the Lithium and Placebo Groups | Trial comparisons |
| Lithium Carbonate vs Placebo: deaths from any cause | Trial comparisons |
| Lithium Carbonate vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02862210
GET https://conductscience.org/api/trials/v1/NCT02862210/registered