What side effects are associated with this type of intervention?

Common treatments for Mild Cognitive Impairment (MCI) include lithium, cholinesterase inhibitors, and memantine. Lithium can cause tremor, increased thirst, diarrhea, and subclinical hypothyroidism. Cholinesterase inhibitors often lead to gastrointestinal issues, muscle cramps, and insomnia. Memantine may result in dizziness, headache, confusion, and occasionally hallucinations or worsened neuropsychiatric symptoms.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cognitive impairment and dementia, primarily focusing on Alzheimer's disease. These include cholinesterase inhibitors like donepezil and NMDA receptor antagonists like memantine. Donepezil is used to improve cognitive function by increasing acetylcholine levels in the brain, while memantine helps to protect neurons from excitotoxicity by blocking NMDA receptors. Although lithium is being studied for its potential neuroprotective properties in delaying dementia onset, it is not yet FDA-approved for this indication. Current treatments aim to manage symptoms and slow disease progression rather than providing a cure.

What other types of research exist?

Promising alternatives to lithium for MCI patients include cholinesterase inhibitors (e.g., donepezil) and NMDA receptor antagonists (e.g., memantine). These treatments have shown efficacy in improving cognitive function and slowing disease progression in Alzheimer's disease, which shares similarities with MCI. Additionally, ongoing research into the use of combination therapies, such as donepezil with memantine, may offer enhanced benefits. Other potential treatments under investigation include neuroprotective agents like vitamin E and novel drugs targeting amyloid plaques and tau proteins.

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Mood Stabilizer

Lithium for Mild Cognitive Impairment (LATTICE Trial)

Phase 4

Waitlist Available

Research Sponsored by Ariel Gildengers, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Major neurologic illness (e.g., multiple sclerosis)

Contraindication to lithium (e.g., renal insufficiency)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and annually for 2 years

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing whether lithium can help slow down or delay Alzheimer's disease in older adults with mild cognitive impairment. Lithium is believed to support brain health by encouraging new brain cell growth, protecting existing cells, and reducing harmful proteins. The study will compare the effects of lithium over time to see if it helps maintain memory and cognitive function. Lithium has been studied for its potential to slow cognitive decline and modify Alzheimer's disease pathology, with some studies showing it may block harmful proteins and support brain health.

Who is the study for?

This trial is for people aged 60 or older who have been diagnosed with mild cognitive impairment. It's not suitable for those with conditions that make lithium use unsafe, like kidney problems, major neurological diseases like multiple sclerosis, serious psychiatric issues, or if they can't do certain mental tests due to permanent disabilities.

What is being tested?

The study is testing whether lithium carbonate can prevent or slow down memory loss and decline in brain function in older adults at risk of dementia compared to a placebo (a pill without medication). Participants will be randomly assigned to receive either lithium or the placebo.

What are the potential side effects?

Lithium may cause side effects such as increased thirst and urination, shakiness of the hands, feeling sick or diarrhea. Some people might also experience changes in heart rhythm or thyroid function.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a major neurological illness like multiple sclerosis.

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I cannot take lithium due to kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and annually for 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and annually for 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and annually for 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain-derived Neurotrophic Factor

Brief Visuospatial Memory Test - Revised

California Verbal Learning Test II

+4 more

Secondary study objectives

Change from baseline brain integrity measures over 2 years as measured by structural imaging (7T MRI)

Change from baseline cerebrospinal phospho tau levels over 2 years

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lithium carbonateExperimental Treatment1 Intervention

Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels until a steady blood level between 0.6 and 0.8 meq/L is achieved. Participants will continue at the dose achieved for 2 years with quarterly monitoring.

Group II: placeboPlacebo Group1 Intervention

Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lithium Carbonate

2008

Completed Phase 4

~1270

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lithium, a common treatment being studied for Mild Cognitive Impairment (MCI), works through several mechanisms, including modulation of neurotransmitter release, inhibition of glycogen synthase kinase-3 (GSK-3), and promoting neurotrophic effects that enhance neuronal survival and plasticity. These mechanisms are crucial for MCI patients as they may help preserve cognitive function and delay the progression to more severe forms of dementia, such as Alzheimer's disease.