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LATTICE

CompletedPhase 4Results posted

Lithium As a Treatment to Prevent Impairment of Cognition in Elders

Evaluation of Brain and Cognitive Changes in Older Adults With MCI Taking Lithium to Prevent Alzheimer Type Dementia

Lead sponsor

Ariel Gildengers, MD

Asset

Lithium

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Age ≥60

Primary endpoints

•California Verbal Learning Test II•Brief Visuospatial Memory Test - Revised•Preclinical Alzheimer Cognitive Composite Composed of Memory

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03185208

Org study IDPRO17030527

NihR01AG055389-01

Timeline

Milestones

Study first posted2017-06-14actual

Study start2018-02-02actual

Primary completion2024-08-06actual

Study completion2024-08-06actual

Last update posted2025-09-11actual

Results first posted2025-09-11actual

Assets

Drug assets

Lithium

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. 60 years or older

2. Diagnosis of Mild Cognitive Impairment

Exclusion criteria

1. Major psychiatric illness (mild psychiatric illness may be included)

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

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

4. Unable to complete neuropsychological testing due to non-remediable impairment (e.g., blindness)

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Neuroimaging

Memory

Other (unclassified)

Global cognition

Fluid / digital biomarkers

Other clinical outcomes

Global cognition

2 endpoints

Primary/protocol endpoint

Preclinical Alzheimer Cognitive Composite Composed of Memory and Other Cognitive Tests

Time frame:Year 1 and Year 2

descriptive

Primary/registry result

Preclinical Alzheimer Cognitive Composite Composed of Memory and Other Cognitive Tests

Time frame:Year 1 and Year 2

descriptive

Posted result

Group	Value (mean), Z-score	Standard deviation
Lithium CarbonateYear 1n=35 Participants	0.10	4.3
Year 2n=37 Participants	-0.67	5.67
PlaceboYear 1n=25 Participants	0.43	3.7
Year 2n=28 Participants	-0.19	4.04

treatment x time interaction coefficient0.08738p0.80Mixed Models Analysis

Memory

4 endpoints

Primary/protocol endpoint

California Verbal Learning Test II

Time frame:Year 1 and Year 2

descriptive

Primary/protocol endpoint

Brief Visuospatial Memory Test - Revised

Time frame:Year 1 and Year 2

descriptive

Primary/registry result

California Verbal Learning Test II

Time frame:Year 1 and Year 2

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Lithium CarbonateYear 1n=37 Participants	6.9	4.0
Year 2n=37 Participants	6.46	3.97
PlaceboYear 1n=31 Participants	6.2	4.6
Year 2n=31 Participants	5.10	4.54

treatment x time interaction coefficient0.69p0.048Mixed Models Analysis

Primary/registry result

Brief Visuospatial Memory Test - Revised

Time frame:Year 1 and Year 2

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Lithium CarbonateYear 1n=38 Participants	5.97	3.2
Year 2n=36 Participants	5.69	3.4
PlaceboYear 1n=31 Participants	5.9	3.1
Year 2n=31 Participants	6.19	3.73

treatment x time interaction coefficient-0.08835p0.78Mixed Models Analysis

Neuroimaging

6 endpoints

Primary/protocol endpoint

Cerebral Cortical Gray Matter Volume

Time frame:Year 1 and Year 2

descriptive

Primary/protocol endpoint

Hippocampal Volume

Time frame:Year 1 and Year 2

descriptive

Primary/registry result

Cerebral Cortical Gray Matter Volume

Time frame:Year 1 and Year 2

descriptive

Posted result

Group	Value (mean), mm^3	Standard deviation
Lithium CarbonateYear 1n=31 Participants	412951	24063
Year 2n=28 Participants	411270	27271
PlaceboYear 1n=23 Participants	405236	16950
Year 2n=22 Participants	402212	19033

treatment x time interaction coefficient-351.8p0.78Mixed Models Analysis

Primary/registry result

Hippocampal Volume

Time frame:Year 1 and Year 2

descriptive

Posted result

Group	Value (mean), mm^3	Standard deviation
Lithium CarbonateYear 1n=31 Participants	7352	847
Year 2n=28 Participants	7369	812
PlaceboYear 1n=23 Participants	7118	816
Year 2n=22 Participants	6884	922

treatment x time interaction coefficient58.95p0.087Mixed Models Analysis

Other/protocol endpoint

Brain Integrity as Measured by Structural Imaging (7T MRI)

Time frame:Year 1 and Year 2

descriptive

Other_pre_specified/registry result

Brain Integrity as Measured by Structural Imaging (7T MRI)

Time frame:Year 1 and Year 2

descriptive

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

Cerebrospinal Fluid Phospho Tau Level (CSF)

Time frame:Year 1 and Year 2

descriptive

Secondary/registry result

Cerebrospinal Fluid Phospho Tau Level (CSF)

Time frame:Year 1 and Year 2

descriptive

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Brain-derived Neurotrophic Factor

Time frame:Year 1 and Year 2

threshold achievement, improvement

Primary/registry result

Brain-derived Neurotrophic Factor

Time frame:Year 1 and Year 2

threshold achievement, improvement

Posted result

Group	Value (mean), Log transformed number of molecules	Standard deviation
Lithium CarbonateYear 1n=37 Participants	14.5	1.02
Year 2n=38 Participants	14.5	0.90
PlaceboYear 1n=26 Participants	14.1	1.71
Year 2n=31 Participants	14.3	1.33

treatment x time interaction coefficient0.012p0.93Mixed Models Analysis

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Glycogen Synthase Kinase-3 Beta (GSK-3β) Activity

Time frame:Year 1 and Year 2

descriptive

Primary/registry result/low confidence

Glycogen Synthase Kinase-3 Beta (GSK-3β) Activity

Time frame:Year 1 and Year 2

descriptive

Post_hoc/registry result/low confidence

NIH Toolbox

Time frame:Year 1 and Year 2

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.