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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and annually for 2 years
Awards & highlights

LATTICE Trial Summary

This trial will examine whether lithium has anti-dementia properties in people with mild cognitive impairment who are at risk of becoming demented.

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.Check my eligibility
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.See study design
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.

LATTICE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline biomarker values over 2 years
Change from baseline brain volume values over 2 years as measured by structural imaging (7T MRI)
Change from baseline cognitive testing measures over 2 years
Secondary outcome measures
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

LATTICE 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
~1280

Find a Location

Who is running the clinical trial?

Ariel Gildengers, MDLead Sponsor
National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,004,984 Total Patients Enrolled

Media Library

Lithium Carbonate (Mood Stabilizer) Clinical Trial Eligibility Overview. Trial Name: NCT03185208 — Phase 4

Frequently Asked Questions

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

How many participants are entering the experiment?

"At this moment, no candidates are being sought for the trial in question. Initially posted on September 1st 2017 and last revised on June 6th 2022, it has been concluded that recruitment is not necessary at present. However, if you seek other studies to participate in there are 568 trials recruiting those with mild cognitive impairment (MCI) and 10 admitting participants for Lithium Carbonate treatment."

Answered by AI

Are there any vacancies for participation in this research study?

"Clinicaltrials.gov suggests that this study, initially posted on September 1st 2017 and recently edited June 6th 2022, is presently not enrolling patients. However, there are 578 other medical trials seeking participants at the present moment."

Answered by AI

Has the FDA given their stamp of approval to Lithium Carbonate?

"Lithium Carbonate is rated a 3 for safety as this treatment has been approved, which means it's reached Phase 4 of the clinical trial process."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
University of Pittsburgh Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I do not want to get Alzheimer's Disease.
PatientReceived no prior treatments
~1 spots leftby May 2024