UnknownPhase 2

Disease-modifying Properties of Lithium in the Neurobiology of Alzheimer's Disease

Disease-modifying Properties of Lithium in the Neurobiology of Alzheimer's Disease: a Double-blind, Placebo-controlled Prevention Study in Elderly Patients With Mild Cognitive Impairment

Lead sponsor

University of Sao Paulo

Asset

Lithium

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Age 60-80

Primary endpoint

•Effect of lithium to delay progression of cognitive deficits

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

Other grant554535/2005-0Conselho Nacional de Pesquisa Científica

NCT IDNCT01055392

Org study IDOVForlenza-Lithium

Timeline

Milestones

Study start2007-03 (month precision)

Primary completion2009-03actual (month precision)

Study first posted2010-01-25estimated

Last update posted2010-01-25estimated

Assets

Drug assets

Lithium

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age60 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•patients with amnestic mild cognitive impairment;

•age: 60 to 80 years-old

Exclusion criteria

•sensory deficiencies that might preclude the administration of cognitive tests;

•active major psychiatry disorder;

•unstable clinical conditions such as cardiac insufficiency, uncontrolled diabetes mellitus, renal failure;

•previous use of lithium salts;

•concurrent participation in other clinical trial or intervention studies;

Endpoints (3)

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

Other (unclassified)

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

effect of lithium on CSF levels of Total Tau, Phosphorylated Tau and Amyloid-beta42

Time frame:one year

descriptive

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

effect of lithium to delay progression of cognitive deficits in patients with amnestic MCI

Time frame:two year

descriptive

Secondary/protocol endpoint/low confidence

the effect of lithium on the activity of GSK3β in platelets and leukocytes drawn from peripheral blood.

Time frame:one year

descriptive

Publications (3)

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 tableno registry results posted yet

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.