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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• Main ID: NCT02862210
• Date of registration: 07/08/2016
• Prospective Registration: Yes
• Primary sponsor: Columbia University
• Public title: Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia Lithium
• Scientific title: Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia
• Date of first enrolment: January 27, 2017
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02862210
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Edward Huey, MD
• Affiliation: Brown University

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Frontotemporal Dementia (FTD)

Intervention(s)

Drug: Lithium Carbonate

Drug: Placebo

Primary Outcome(s)

Change in agitation and aggression as measured by the Neuropsychiatric Inventory Scale (NPI) [Time Frame: 12 weeks]

Secondary Outcome(s)

Proportion of responders in the lithium and placebo groups [Time Frame: 12 weeks]

Secondary ID(s)

NYSPI 7310

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Alzheimer's Drug Discovery Foundation