Mild Cognitive ImpairmentPhase 4LATTICENCT03185208
Lithium As a Treatment to Prevent Impairment of Cognition in Elders
A Phase 4 study testing Lithium Carbonate in people with Mild Cognitive Impairment, run by Ariel Gildengers, MD at 1 site in United States.
Trial summary
Alzheimer's disease (AD) is the most common cause of dementia in adults 65 years and older. AD leads to a complete loss of memory and independent function, and presently there is no cure. Many studies suggest that lithium treatment may delay dementia onset or slow its progression. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Lithium Carbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2018to 6 Aug 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years or older
- Diagnosis of Mild Cognitive Impairment
Who cannot join
- Major psychiatric illness (mild psychiatric illness may be included)
- Major neurologic illness (e.g., multiple sclerosis)
- Contraindication to lithium (e.g., renal insufficiency)
- Unable to complete neuropsychological testing due to non-remediable impairment (e.g., blindness)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Evaluation of Brain and Cognitive Changes in Older Adults With MCI Taking Lithium to Prevent Alzheimer Type Dementia
Alzheimer's disease (AD) is the most common cause of dementia in adults 65 years and older. AD leads to a complete loss of memory and independent function, and presently there is no cure. Many studies suggest that lithium treatment may delay dementia onset or slow its progression. However, more research is needed to understand the extent of its anti-dementia properties if it will be deployed broadly in the general population. This study will examine whether lithium has anti-dementia properties in older adults who have mild cognitive impairment and are at risk of becoming demented.
Read the detailed description
Alzheimer's disease (AD) is the most common cause of dementia in adults 65 years and older. Unchecked, the disease will reach epidemic proportions in the United States and worldwide by 2050, and presently, there is no intervention that has shown a clear effect on AD progression. Over the past several years, there has been increasing interest in re-purposing the use of lithium for diseases involving neurodegeneration. Lithium treatment has been associated with neurogenesis in the hippocampus, up-regulation of important neurotrophic factors such as B-cell lymphoma 2 (Bcl-2) and brain-derived neurotrophic factor (BDNF), and inhibition of glycogen synthase kinase 3 (GSK-3) isoforms α and β. In particular, GSK-3α interacts with gamma-secretase playing a critical role in the conversion of amyloid precursor protein (APP) to amyloid-beta (Aβ); lithium has been shown to reduce Aβ production and memory deficits in AD transgenic mouse models. GSK-3β phosphorylates tau, a critical step in the formation of neurofibrillary tangles, and lithium has been shown to reduce tau phosphorylation in vivo and in vitro. That lithium may alter the AD trajectory is supported by numerous observational reports showing delay of dementia onset in those treated with it. However, the results of the few human lithium trials conducted have been mixed. Additional research is needed to determine whether lithium has a role as an anti-dementia agent. In contrast to previous studies, we will implement an Randomized Controlled Trial (RCT) with a more integrative, comprehensive approach than done before involving state-of-the-art ultra-high field (7T) human Magnetic Resonance Imaging (MRI), neurocognitive assessment, and blood- and Cerebrospinal Fluid (CSF)- based biomarker measurement to investigate the role of lithium as an anti-dementia agent. The specific aim of this pilot-feasibility study is to examine the potential disease modifying properties of lithium in individuals with mild cognitive impairment (MCI) in delaying conversion to dementia. The study will enroll and randomly assign 80 individuals 60 years and older with MCI to take lithium, titrated to a maximally tolerated blood level (0.5 to 0.8 meq/L), or placebo for two years to assess lithium's effects on preserving cognition and delaying conversion to dementia. Participants will receive annual neurocognitive assessment, blood- and CSF-based biomarker measurement, and 7T MRI of structural brain volumes (e.g., hippocampal, total cortical gray). At baseline, all subjects who are able will undergo Positron Emission Tomography (PET) imaging for Aβ. The following hypotheses will be tested: H1: a) Participants randomized to take lithium for two years, compared to placebo, will better maintain cognitive function, primarily in memory, which b) will be associated with changes in biomarkers (e.g., GSK-3β, BDNF). H2: a) Participants randomized to take lithium, compared to placebo, will have larger hippocampal volumes and lower total gray matter thinning, which b) will be associated with changes in biomarkers and c) better cognitive function, primarily in memory. The exploratory aim examines whether lithium is related to additional markers of enhanced brain integrity (e.g., lower level of microbleeds, higher white matter integrity, better network connectivity, or decreased CSF phospho tau levels).
The following amendments were made with entering the results to correct mistakes in the original registration:
- Primary Outcome 6 was corrected to Cerebral Cortical Gray Matter Volume.
- Primary Outcome 7 was correct to Hippocampal Volume.
- The outcome measure "Change From Baseline Brain Integrity Measures Over 2 Years as Measured by Structural Imaging (7T MRI)" was corrected to Other Pre-Specified Outcome Measure(s).
- The outcome measure "NIH Toolbox" was corrected to PostHoc Outcome Measure(s).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Lithium Carbonate, Placebo oral capsule
- Keywords
- Lithium, Mild Cognitive Impairment, MCI, Dementia, Alzheimer, Alzheimer's Disease, Cognition, Memory, Thinking, Prevention, amyloid, imaging, MRI, PET, tau, plaques, tangles
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease, Pick Disease of the Brain, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium CarbonateDrug
See lithium carbonate arm
Placebo oral capsuleDrug
See placebo arm
| Study group | Role | What they receive |
|---|---|---|
| Lithium carbonate | Experimental | 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. Receives: Drug: Lithium Carbonate |
| placebo | Placebo comparator | Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
California Verbal Learning Test II
California Verbal Learning Test II. Long-delay free recall. Scores range from 0 - 16; higher means better.
Measured: Year 1 and Year 2
Brief Visuospatial Memory Test - Revised
Brief Visuospatial Memory Test - Revised. Delayed Recall. Scores range from 0 - 12; higher means better.
Measured: Year 1 and Year 2
Preclinical Alzheimer Cognitive Composite Composed of Memory and Other Cognitive Tests
Cognitive testing measures with a composite of memory, executive function, processing speed, activities of daily living, and general cognition tests. Values are Z-scores. Higher values mean better cognition. A Z-score of 0 represents the population mean, while Z-scores of ±1 capture approximately 68% of the data around the mean and Z-scores of ±2 capture approximately 95% of the data in a normal distribution.
Measured: Year 1 and Year 2
Glycogen Synthase Kinase-3 Beta (GSK-3β) Activity
Values of blood-based biomarkers
Measured: Year 1 and Year 2
Brain-derived Neurotrophic Factor
Brain-Derived Neurotrophic Factor (BDNF) supports neuron survival and growth; reduced levels linked to neurodegeneration. Nucleic Acid-Linked Immuno-Sorbent Assay (NULISA) measures BDNF using nucleic acid-tagged antibody pairs recognizing different BDNF epitopes. Sequential capture/purification via polyA/biotin tails, then ligation and next-generation sequencing quantification achieves attomolar sensitivity alongside hundreds of other proteins.
Measured: Year 1 and Year 2
Cerebral Cortical Gray Matter Volume
Cerebral cortical gray matter volume as measured by structural imaging (7T MRI) corrected for age, sex, and intracranial volume
Measured: Year 1 and Year 2
Hippocampal Volume
Hippocampal volume values as measured by structural imaging (7T MRI) corrected for age, sex, and intracranial volume
Measured: Year 1 and Year 2
Secondary outcomes (1)
Cerebrospinal Fluid Phospho Tau Level (CSF)
Cerebrospinal fluid phospho tau levels
Measured: Year 1 and Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start2 Feb 2018
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal, randomized, double-blind, placebo-controlled experimental trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariel Gildengers, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Ariel Gildengers, MD, University of Pittsburgh
- Investigators
- Ariel Gildengers, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185208
- Sponsor's protocol ID
- PRO17030527
- Other IDs
- R01AG055389-01
- Acronym
- LATTICE
- Status last verified
- Aug 2025
- First submitted
- 24 Apr 2017
- Last updated
- 11 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be shared with the National Cell Repository for Alzheimer's Disease (NCRAD).
Publications
Gildengers AG, Ibrahim TS, Anderson SJ, Emanuel JE, Santini T, Diaz JL, Lopresti BJ, Royse SK, Lopez OL, Zeng X, de Almeida B, Alkhateeb SK, Chu C, Karikari TK, Lee L, Weinstein AM, Butters MA. Low-Dose Lithium for Mild Cognitive Impairment: A Pilot Randomized Clinical Trial. JAMA Neurol. 2026 Apr 1;83(4):310-319. doi: 10.1001/jamaneurol.2026.0072.
PubMed 41770546Gildengers AG, Ibrahim TS, Zeng X, Aizenstein HJ, Alkhateeb SK, Anderson SJ, Chu C, Diaz JL, Emanuel JE, Karikari TK, Li J, Lopez OL, Lopresti BJ, Royse SK, Sajewski AN, Santini T, Weinstein AM, Wu M, Butters MA. The LATTICE Study: Design of a pilot feasibility randomized controlled trial of lithium to delay cognitive decline in mild cognitive impairment. Alzheimers Dement (N Y). 2025 Jun 11;11(2):e70112. doi: 10.1002/trc2.70112. eCollection 2025 Apr-Jun.
PubMed 40501510
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain and Cognitive Changes in Older Adults With MCI Taking Lithium to Prevent Alzheimer Type Dementia
- ClinicalTrials.gov ID
- NCT03185208
- Acronym / sponsor ID
- LATTICE / PRO17030527
- Conditions
- Mild Cognitive Impairment
- Keywords
- Lithium, Mild Cognitive Impairment, MCI, Dementia, Alzheimer, Alzheimer's Disease, Cognition, Memory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Ariel Gildengers, MDUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alzheimer's disease (AD) is the most common cause of dementia in adults 65 years and older. AD leads to a complete loss of memory and independent function, and presently there is no cure. Many studies suggest that lithium treatment may delay dementia onset or slow its progression. However, more research is needed to understand the extent of its anti-dementia properties if it will be deployed broadly in the general population. This study will examine whether lithium has anti-dementia properties in older adults who have mild cognitive impairment and are at risk of becoming demented.
Detailed description
Alzheimer's disease (AD) is the most common cause of dementia in adults 65 years and older. Unchecked, the disease will reach epidemic proportions in the United States and worldwide by 2050, and presently, there is no intervention that has shown a clear effect on AD progression. Over the past several years, there has been increasing interest in re-purposing the use of lithium for diseases involving neurodegeneration. Lithium treatment has been associated with neurogenesis in the hippocampus, up-regulation of important neurotrophic factors such as B-cell lymphoma 2 (Bcl-2) and brain-derived neurotrophic factor (BDNF), and inhibition of glycogen synthase kinase 3 (GSK-3) isoforms α and β. In particular, GSK-3α interacts with gamma-secretase playing a critical role in the conversion of amyloid precursor protein (APP) to amyloid-beta (Aβ); lithium has been shown to reduce Aβ production and memory deficits in AD transgenic mouse models. GSK-3β phosphorylates tau, a critical step in the formation of neurofibrillary tangles, and lithium has been shown to reduce tau phosphorylation in vivo and in vitro. That lithium may alter the AD trajectory is supported by numerous observational reports showing delay of dementia onset in those treated with it. However, the results of the few human lithium trials conducted have been mixed. Additional research is needed to determine whether lithium has a role as an anti-dementia agent. In contrast to previous studies, we will implement an Randomized Controlled Trial (RCT) with a more integrative, comprehensive approach than done before involving state-of-the-art ultra-high field (7T) human Magnetic Resonance Imaging (MRI), neurocognitive assessment, and blood- and Cerebrospinal Fluid (CSF)- based biomarker measurement to investigate the role of lithium as an anti-dementia agent. The specific aim of this pilot-feasibility study is to examine the potential disease modifying properties of lithium in individuals with mild cognitive impairment (MCI) in delaying conversion to dementia. The study will enroll and randomly assign 80 individuals 60 years and older with MCI to take lithium, titrated to a maximally tolerated blood level (0.5 to 0.8 meq/L), or placebo for two years to assess lithium's effects on preserving cognition and delaying conversion to dementia. Participants will receive annual neurocognitive assessment, blood- and CSF-based biomarker measurement, and 7T MRI of structural brain volumes (e.g., hippocampal, total cortical gray). At baseline, all subjects who are able will undergo Positron Emission Tomography (PET) imaging for Aβ. The following hypotheses will be tested: H1: a) Participants randomized to take lithium for two years, compared to placebo, will better maintain cognitive function, primarily in memory, which b) will be associated with changes in biomarkers (e.g., GSK-3β, BDNF). H2: a) Participants randomized to take lithium, compared to placebo, will have larger hippocampal volumes and lower total gray matter thinning, which b) will be associated with changes in biomarkers and c) better cognitive function, primarily in memory. The exploratory aim examines whether lithium is related to additional markers of enhanced brain integrity (e.g., lower level of microbleeds, higher white matter integrity, better network connectivity, or decreased CSF phospho tau levels).
The following amendments were made with entering the results to correct mistakes in the original registration:
- Primary Outcome 6 was corrected to Cerebral Cortical Gray Matter Volume.
- Primary Outcome 7 was correct to Hippocampal Volume.
- The outcome measure "Change From Baseline Brain Integrity Measures Over 2 Years as Measured by Structural Imaging (7T MRI)" was corrected to Other Pre-Specified Outcome Measure(s).
- The outcome measure "NIH Toolbox" was corrected to PostHoc Outcome Measure(s).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Longitudinal, randomized, double-blind, placebo-controlled experimental trial
| Arm | Type | Receives |
|---|---|---|
| Lithium carbonate | Experimental | Drug: Lithium CarbonateLithium 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. |
| placebo | Placebo comparator | Drug: Placebo oral capsuleMatching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 years or older
- Diagnosis of Mild Cognitive Impairment
Key exclusion criteria (4 listed)
- Major psychiatric illness (mild psychiatric illness may be included)
- Major neurologic illness (e.g., multiple sclerosis)
- Contraindication to lithium (e.g., renal insufficiency)
- Unable to complete neuropsychological testing due to non-remediable impairment (e.g., blindness)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithium CarbonateSee lithium carbonate arm | Drug | Lithium carbonate |
| Placebo oral capsuleSee placebo arm | Drug | placebo |
Primary outcome
California Verbal Learning Test II
Time frame: Year 1 and Year 2
California Verbal Learning Test II. Long-delay free recall. Scores range from 0 - 16; higher means better.
Brief Visuospatial Memory Test - Revised
Time frame: Year 1 and Year 2
Brief Visuospatial Memory Test - Revised. Delayed Recall. Scores range from 0 - 12; higher means better.
Preclinical Alzheimer Cognitive Composite Composed of Memory and Other Cognitive Tests
Time frame: Year 1 and Year 2
Cognitive testing measures with a composite of memory, executive function, processing speed, activities of daily living, and general cognition tests. Values are Z-scores. Higher values mean better cognition. A Z-score of 0 represents the population mean, while Z-scores of ±1 capture approximately 68% of the data around the mean and Z-scores of ±2 capture approximately 95% of the data in a normal distribution.
Glycogen Synthase Kinase-3 Beta (GSK-3β) Activity
Time frame: Year 1 and Year 2
Values of blood-based biomarkers
Brain-derived Neurotrophic Factor
Time frame: Year 1 and Year 2
Brain-Derived Neurotrophic Factor (BDNF) supports neuron survival and growth; reduced levels linked to neurodegeneration. Nucleic Acid-Linked Immuno-Sorbent Assay (NULISA) measures BDNF using nucleic acid-tagged antibody pairs recognizing different BDNF epitopes. Sequential capture/purification via polyA/biotin tails, then ligation and next-generation sequencing quantification achieves attomolar sensitivity alongside hundreds of other proteins.
Cerebral Cortical Gray Matter Volume
Time frame: Year 1 and Year 2
Cerebral cortical gray matter volume as measured by structural imaging (7T MRI) corrected for age, sex, and intracranial volume
Hippocampal Volume
Time frame: Year 1 and Year 2
Hippocampal volume values as measured by structural imaging (7T MRI) corrected for age, sex, and intracranial volume
1 secondary outcome
Cerebrospinal Fluid Phospho Tau Level (CSF)
Time frame: Year 1 and Year 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41770546Gildengers AG, Ibrahim TS, Anderson SJ, Emanuel JE, Santini T, Diaz JL, Lopresti BJ, Royse SK, Lopez OL, Zeng X, de Almeida B, Alkhateeb SK, Chu C, Karikari TK, Lee L, Weinstein AM, Butters MA. Low-Dose Lithium for Mild Cognitive Impairment: A Pilot Randomized Clinical Trial. JAMA Neurol. 2026 Apr 1;83(4):310-319. doi: 10.1001/jamaneurol.2026.0072.
- Derived from this study: PubMed 40501510Gildengers AG, Ibrahim TS, Zeng X, Aizenstein HJ, Alkhateeb SK, Anderson SJ, Chu C, Diaz JL, Emanuel JE, Karikari TK, Li J, Lopez OL, Lopresti BJ, Royse SK, Sajewski AN, Santini T, Weinstein AM, Wu M, Butters MA. The LATTICE Study: Design of a pilot feasibility randomized controlled trial of lithium to delay cognitive decline in mild cognitive impairment. Alzheimers Dement (N Y). 2025 Jun 11;11(2):e70112. doi: 10.1002/trc2.70112. eCollection 2025 Apr-Jun.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be shared with the National Cell Repository for Alzheimer's Disease (NCRAD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Gildengers, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lithium Carbonate in people with Mild Cognitive Impairment, run by Ariel Gildengers, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
California Verbal Learning Test II (time frame: Year 1 and Year 2). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185208, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.