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CompletedPhase 1 / PHASE2Results posted

A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration

Lead sponsor

Westat

Asset

Lithium

Listed sites

9

Recruiting sites

-

Enrollment

17

actual

Study population

Frontotemporal dementia

Key I/E criterion

Age 40-80

Primary endpoint

Ability to Tolerate Lithium Carbonate

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 grantHHSN265200423611CNIH Contract
NCT IDNCT00703677
Org study IDNPTUNE_PSP_CBD

Timeline

Milestones

Study first posted2008-06-23estimated
Study start2008-09 (month precision)
Primary completion2010-01actual (month precision)
Study completion2010-01actual (month precision)
Results first posted2010-06-11estimated
Last update posted2024-05-17actual

Assets

Drug assets

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Able to give informed consent

2. Able to comply with the study protocol, including ability to attend follow-up study visits for the duration of the study

3. Diagnosis of PSP or CBD based on the following criteria:

1. Probable PSP:

-Gradually progressive akinetic disorder
-Unequivocal and prominent slowing of vertical saccades or vertical supranuclear gaze palsy
-Early prominent postural instability or early falls
-Poor or absent response to levodopa

2. Probable CBD:

-Chronic progressive course
-Asymmetric onset
-Presence of higher cortical dysfunction (apraxia, apraxia of speech, non-fluent aphasia, cortical sensory loss, or alien limb)
-Movement disorder: rigid/akinetic syndrome resistant to levodopa and either dystonic limb posturing or focal myoclonus in limb (spontaneous or stimulus sensitive)

4. If psychotropic or anti-parkinsonian medications are taken (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants, levodopa, amantadine), the dosage must be stable for 28 days prior to the screening visit and should be maintained at constant dosages throughout the study, as possible

5. If NSAIDs, ACE-Is, ARBs, thiazide diuretics, COX-2 inhibitors or theophylline are taken by the subject, the dosage must be stable for 28 days prior to the screening visit and should be maintained at constant dosages throughout the study, as possible.

6. Creatinine clearance > 50 ml/min

7. Able to take oral medication

8. Women must not be able to become pregnant (e.g., post menopausal, surgically sterile or using adequate birth control methods for the duration of the study.)

9. Able to identify a study partner

Exclusion criteria

1. Evidence of other diseases that could explain the clinical presentation

2. History of known sensitivity or intolerability to lithium or to other known ingredients in the study drug

3. Exposure to any investigational agent within 28 days of the screening visit

4. Clinically significant cardiac disease or EKG findings

5. Other serious illness, including psychiatric illness ("serious illness" is defined as an illness that is unstable enough that it might jeopardize the subject's ability to complete the study)

6. Moderate to severe ongoing depression

7. Family history of "PSP" or "CBS"

8. Clinically significant abnormalities on the screening visit laboratory results

9. Any AE ≥ Grade 3 as listed on the CTCAE, version 3.0

10. Women who are pregnant or breastfeeding

11. History of brain surgery

12. Use of other potential GSK-3β inhibitors (e.g., valproic acid)

13. Use of iodide salts [e.g., calcium iodide, hydrogen iodide (hydriodic acid), iodide, iodinated glycerol (Organidin), iodine, potassium iodide (SSKI), and sodium iodide]

14. Previous use of lithium

15. Use of Coenzyme Q10 at a dosage greater than 600 mg a day or NanoQuinon at a dosage greater than 150mg a day or 2.5 mg/kg a day

16. Active psoriasis

Endpoints (20)

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)
8
Behavior / neuropsychiatric
4
Executive function / language
2
Tau biomarkers
2
Fluid / digital biomarkers
2
Caregiver / quality of life
2

Executive function / language

2 endpoints
Secondary/protocol endpoint

Frontal Assessment Battery (FAB): Change From Baseline

Time frame:28 weeks

change from baseline, improvement

Secondary/registry result

Frontal Assessment Battery (FAB): Change From Baseline

Time frame:28 weeks

change from baseline, improvement

Behavior / neuropsychiatric

4 endpoints
Secondary/protocol endpoint

PSP Rating Scale Score: Change From Baseline

Time frame:28 weeks

change from baseline, improvement

Secondary/protocol endpoint

Geriatric Depression Scale(GDS)-15:Change From Baseline

Time frame:28 weeks

change from baseline, improvement

Secondary/registry result

PSP Rating Scale Score: Change From Baseline

Time frame:28 weeks

change from baseline, improvement

Secondary/registry result

Geriatric Depression Scale(GDS)-15:Change From Baseline

Time frame:28 weeks

change from baseline, improvement

Tau biomarkers

2 endpoints
Secondary/protocol endpoint

Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF)

Time frame:28 weeks

ratio, descriptive

Secondary/registry result

Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF)

Time frame:28 weeks

ratio, descriptive

Fluid / digital biomarkers

2 endpoints
Secondary/protocol endpoint

Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF

Time frame:28 weeks

change from baseline, improvement

Secondary/registry result

Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF

Time frame:28 weeks

change from baseline, improvement

Caregiver / quality of life

2 endpoints
Secondary/protocol endpoint

PSP-Quality of Life Scale (QoL):Change From Baseline

Time frame:28 weeks

change from baseline, improvement

Secondary/registry result

PSP-Quality of Life Scale (QoL):Change From Baseline

Time frame:28 weeks

change from baseline, improvement

Other (unclassified)

8 endpoints
Primary/protocol endpoint/low confidence

Ability to Tolerate Lithium Carbonate

Time frame:28 weeks

concentration, descriptive

Primary/registry result/low confidence

Ability to Tolerate Lithium Carbonate

Time frame:28 weeks

concentration, descriptive

Posted result

GroupValue (number), SubjectReported bounds
Lithium Carbonaten=14 Participants1-
Secondary/protocol endpoint/low confidence

Study Drug Compliance

Time frame:28 weeks

descriptive

Secondary/protocol endpoint/low confidence

Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity

Time frame:28 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline

Time frame:28 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Study Drug Compliance

Time frame:28 weeks

descriptive

Posted result

GroupValue (number), SubjectsReported bounds
Lithium Carbonaten=14 Participants14-
Secondary/registry result/low confidence

Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity

Time frame:28 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline

Time frame:28 weeks

change from baseline, improvement

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.