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Lithium

CompletedPhase 2Results posted

Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia

Lead sponsor

Columbia University

Asset

Lithium

Listed sites

Recruiting sites

Enrollment

actual

Study population

Frontotemporal dementia

Key I/E criterion

•MMSE 5-26

Primary endpoint

•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02862210

Org study IDNYSPI 7310

Timeline

Milestones

Study first posted2016-08-10estimated

Study start2017-01-27actual

Primary completion2022-11-20actual

Study completion2022-11-20actual

Last update posted2025-02-03actual

Results first posted2025-02-03actual

Assets

Drug assets

Lithium

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age 40-85

•A diagnosis of behavioral variant FTD (bv-FTD) or semantic variant Primary Progressive Aphasia (sv-PPA, which is generally accompanied by a behavioral syndrome), or agrammatic/non-fluent Primary Progressive Aphasia (nfv-PPA) with behavioral symptoms

•Neuropsychiatric Inventory (NPI) agitation/aggression subscale score ≥4 or disinhibition subscale score ≥ 4 or repetitive behavior subscale ≥ 4 or total score ≥ 6. On each subscale, a score higher than 4 represents moderate to severe symptoms

•Folstein Mini-Mental State Examination (MMSE) score 5-26/30

•An study partner (usually a family member) is required to provide information during interviews about the patient

•Capacity to consent. Subjects without capacity to consent must have capacity to appoint a surrogate

•Structural MRI or CT scan after symptom onset

Exclusion criteria

•Medical contraindication or history of intolerability to lithium, falls in the last month, current abnormal thyroid functions (T3, T4 or thyroid stimulating hormone (TSH); treated hypothyroidism with normal thyroid function tests will not lead to exclusion), creatinine level > 1.5 mg/100 ml or glomerular filtration rate < 44 ml/min/1.73m2 will also lead to exclusion

•The diagnosis of bipolar disorder or schizophrenia or schizoaffective disorder

•Alcohol or substance use disorder in the prior 6 months

•Current diagnosis of other major neurological disorder, e.g., Alzheimer's Disease (AD), stroke with residual clinical deficits, multiple sclerosis, Parkinson's disease. Subjects with MRI or CT evidence of cerebrovascular disease but without clinical signs of stroke will be included

•Sitting blood pressure > 150/90 mm Hg, unstable cardiac disease, severe or unstable medical illness

•Use of medications, including diuretics, known to have adverse effects when combined with lithium. Use of antipsychotic medications will be permitted

•Current major depression or suicidality or dangerous behavior with risk of harm to self and others

•Corrected QT interval (QTc) interval > 460 ms at the time of baseline electrocardiogram (EKG)

•Woman of child-bearing potential

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Safety / tolerability / PK

Behavior / neuropsychiatric

10 endpoints

Primary/protocol endpoint

Change in Agitation and Aggression as Measured by the Neuropsychiatric Inventory Scale (NPI)

Time frame:12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/registry result

Change in Agitation and Aggression as Measured by the Neuropsychiatric Inventory Scale (NPI)

Time frame:12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Lithium Carbonaten=9 Participants	7.14	1.1
Placebon=7 Participants	5.75	1.28

Secondary/protocol endpoint

Number of Responders in the Lithium and Placebo Groups

Time frame:12 weeks

Neuropsychiatric Inventory (NPI)

threshold achievement, improvement

Secondary/registry result

Number of Responders in the Lithium and Placebo Groups

Time frame:12 weeks

Neuropsychiatric Inventory (NPI)

threshold achievement, improvement

Posted result

Group	Value (number), participants	Reported bounds
Lithium Carbonaten=9 Participants	0	-
Placebon=7 Participants	0	-

Other/protocol endpoint

Change in Motor Symptoms as Measured by the NPI

Time frame:12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other/protocol endpoint

The Relationship Between Changes in Brain-derived Neurotropic Factor (BDNF) Serum Levels and Changes in NPI "Agitation/Aggression" Score

Time frame:Baseline and 12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other/protocol endpoint

The Relationship Between Changes in Brain-derived Neurotropic Factor (BDNF) Serum Levels and Changes in NPI "Aberrant Motor Behavior" Score

Time frame:Baseline and 12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other_pre_specified/registry result

Change in Motor Symptoms as Measured by the NPI

Time frame:12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Lithium Carbonaten=9 Participants	6.83	0.95
Placebon=7 Participants	8.8	1.23

Other_pre_specified/registry result

The Relationship Between Changes in Brain-derived Neurotropic Factor (BDNF) Serum Levels and Changes in NPI "Agitation/Aggression" Score

Time frame:Baseline and 12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Lithium Carbonaten=9 Participants	0.71	1.91
Placebon=7 Participants	-1.6	2.11

Other_pre_specified/registry result

The Relationship Between Changes in Brain-derived Neurotropic Factor (BDNF) Serum Levels and Changes in NPI "Aberrant Motor Behavior" Score

Time frame:Baseline and 12 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Lithium Carbonaten=9 Participants	0.4	11.33
Placebon=7 Participants	0.4	1.83

Safety / tolerability / PK

2 endpoints

Other/protocol endpoint

Presence of Adverse Events as Measured by the Treatment Emergent Symptoms Scale (TESS)

Time frame:12 weeks

change from baseline, event

Other_pre_specified/registry result

Presence of Adverse Events as Measured by the Treatment Emergent Symptoms Scale (TESS)

Time frame:12 weeks

change from baseline, event

Posted result

Group	Value (mean), score on a scale	Standard error
Lithium Carbonaten=9 Participants	31.1	0.55
Placebon=7 Participants	31	0.66

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.