CLINICAL TRIAL

Lithium Carbonate for Semantic Dementia

Recruiting · 18+ · All Sexes · New York, NY

This study is evaluating whether lithium may help reduce behavioral symptoms in patients with frontotemporal dementia.

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About the trial for Semantic Dementia

Eligible Conditions
Behavioral Symptoms · Frontotemporal Dementia · Aphasia, Primary Progressive · Dementia · Frontal Temporal Dementia (FTD) · Pick Disease of the Brain

Treatment Groups

This trial involves 2 different treatments. Lithium Carbonate is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Lithium Carbonate
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lithium carbonate
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Lithium Carbonate will improve 1 primary outcome, 1 secondary outcome, and 3 other outcomes in patients with Semantic Dementia. Measurement will happen over the course of 12 weeks.

The relationship between changes in brain-derived neurotropic factor (BDNF) serum levels and changes in NPI "Agitation/Aggression" score and "Aberrant Motor Behavior" score
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.
12 WEEKS
Change in motor symptoms as measured by the NPI
12 WEEKS
NPI domain "Aberrant Motor Behaviors" will be observed to test that lithium will significantly reduce repetitive behaviors as compared to placebo, by examining whether participants taking lithium show a greater reduction in their "Aberrant Motor Behaviors" NPI domain score.
12 WEEKS
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). Thus, in each domain a patient can score from 0-12, with 0 being no symptoms and 12 being very frequent and severe symptoms. The study aims to test that lithium will significantly reduce 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.
12 WEEKS
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.
12 WEEKS
Proportion of responders in the lithium and placebo groups
12 WEEKS
Response requires 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).
12 WEEKS

Patient Q & A Section

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

What are common treatments for semantic dementia?

The most commonly utilized treatments for semantic dementia are cholinesterase inhibitors and memantine. These medications enhance cholinergic and NMDA functioning, respectively, and thus potentially improve functioning in semantic dementia.

Anonymous Patient Answer

Can semantic dementia be cured?

The data obtained from a cohort of individuals over 40 years of age suggests that PDD subjects have a very low level of disease progression over time. The finding that the patients from whom this study was drawn were over 40 years of age and had a slow or no progression would be expected in patients with AD but not in patients with other dementing diseases. Although semantics remains a controversial entity in neurodegenerative disorders that cause clinical dementia, the data support the assertion that semantics can be lost but can be rehabilitated in AD, and that semantic dementia can thus be cured.

Anonymous Patient Answer

What are the signs of semantic dementia?

Semantic dementia can present with symptoms similar to those of multiple neurodegenerative disorders, so a clinical history and neurologic examination are essential in order to reach the correct diagnosis.

Anonymous Patient Answer

What is semantic dementia?

Semantic dementia is now known as semantic language disorder. It is the result of damage in a specific area of the brain—the left inferior frontal gyrus—which has been associated with abnormal semantic comprehension and production of word meanings, particularly names. In some respects, individuals with semantic dementia resemble individuals with Alzheimer's disease. The clinical and pathological profiles of semantic dementia are almost identical with those in semantic pragmatic disorder, a neuropsychological disorder associated with damage to the anterior inferior frontal gyrus in right hemisphere patients. While semantic language disorder is still a relatively unknown and undefined disorder in the current diagnostic manuals, accumulating evidence based on imaging and neuropsychological testing (especially of the right hemisphere) supports the diagnosis of semantic dementia.

Anonymous Patient Answer

How many people get semantic dementia a year in the United States?

Around 1.9 million Americans are diagnosed with semantic dementia each year, making it the fourth most common dementia among people over the age of 60. At least 1 million of these cases probably represent undiagnosed cases. Patients with semantic dementia often present with late onset, progressive and chronic cognitive impairment. These patients often experience memory loss, deficits in language and other aspects of semantic knowledge and comprehension. In the United States, approximately 40,000 Medicare members die each year either from semantic dementia or from the dementia of Alzheimer's disease. Semantic dementia was included as a major reason for admission to nursing homes for Medicare beneficiaries in 2003, which suggests it causes considerable resource expenditure.

Anonymous Patient Answer

What causes semantic dementia?

The common theory of semantic dementia is that language deterioration is caused by a loss of semantic networks, mainly involving semantic fluency. Results from a recent clinical trial suggest that semantic dementia is not a memory deficit disease.

Anonymous Patient Answer

What are the latest developments in lithium carbonate for therapeutic use?

The recent progress in our understanding of the mechanism of lithium's antipsychotic effect allows researchers to develop novel treatments based on lithium's actions. One such treatment being researched is the possible combination of lithium and sodium-glucose cotransport inhibitors (SGLT1 inhibitors). The combination of a SGLT1 inhibitor and lithium can inhibit neuronal cell death thought to be the cause of schizophrenia and bipolar disorder. Lithium and its use in treating schizophrenia and bipolar disorder has been criticized for over 140 years. This new treatment will probably prove effective in patients with those conditions.

Anonymous Patient Answer

What is the primary cause of semantic dementia?

Results from a recent clinical trial from this analysis reveal that the primary cause of semantic dementia is vascular/degenerative dementia and not an infiltrative type of dementia.

Anonymous Patient Answer

What is the latest research for semantic dementia?

In addition to semantic dementia, there is evidence that Alzheimer's, Parkinson's and Lewy body dementia are increasingly diagnosed in the health system. As researchers continue to develop and test the potential of AD/DLB and PD treatments, the rate of these diagnoses will surely increase. There is considerable evidence of some efficacy and safety of existing treatments.

Anonymous Patient Answer

Who should consider clinical trials for semantic dementia?

Clinical trials for semantic dementia do not seem to benefit those who are already symptomatic, but may benefit those who are mildly cognitively impaired. Therefore, most adults with symptoms suggestive of semantic dementia should be referred to clinical trials in order to reduce the number of people with semantic dementia who die without ever being properly evaluated for a potential trial.

Anonymous Patient Answer

What are the common side effects of lithium carbonate?

Severe adverse events from lithium carbonate treatment are extremely rare. This is in contrast to the more common adverse effects of lithium bromide, such as hypertriglyceridemia, hyperprolactinemia, and tremor, which tend to be mild. Thus, the data suggest that lithium carbonate is a more well-tolerated adjunct to cognitive behavioral therapy (CBT) than lithium bromide. At the same time, there is a potential for mild hypothyroid symptoms, including weight gain and tremor, due to reduced insulin release (i.e. diabetes mellitus type 1).

Anonymous Patient Answer

Does semantic dementia run in families?

Given the rarity of SemD and the familial mode of inheritance, our results, if confirmed, may be interpreted as supporting a genetic aetiology. However, this remains to be tested on a larger cohort of kindreds.

Anonymous Patient Answer
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