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A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration
Lead sponsor
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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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:
2. Probable CBD:
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
Executive function / language
2 endpointsFrontal Assessment Battery (FAB): Change From Baseline
Time frame:28 weeks
change from baseline, improvement
Frontal Assessment Battery (FAB): Change From Baseline
Time frame:28 weeks
change from baseline, improvement
Behavior / neuropsychiatric
4 endpointsPSP Rating Scale Score: Change From Baseline
Time frame:28 weeks
change from baseline, improvement
Geriatric Depression Scale(GDS)-15:Change From Baseline
Time frame:28 weeks
change from baseline, improvement
PSP Rating Scale Score: Change From Baseline
Time frame:28 weeks
change from baseline, improvement
Geriatric Depression Scale(GDS)-15:Change From Baseline
Time frame:28 weeks
change from baseline, improvement
Tau biomarkers
2 endpointsChanges in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF)
Time frame:28 weeks
ratio, descriptive
Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF)
Time frame:28 weeks
ratio, descriptive
Fluid / digital biomarkers
2 endpointsChange in Brain-Derived Neurotrophic Factor (BDNF) in CSF
Time frame:28 weeks
change from baseline, improvement
Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF
Time frame:28 weeks
change from baseline, improvement
Caregiver / quality of life
2 endpointsPSP-Quality of Life Scale (QoL):Change From Baseline
Time frame:28 weeks
change from baseline, improvement
PSP-Quality of Life Scale (QoL):Change From Baseline
Time frame:28 weeks
change from baseline, improvement
Other (unclassified)
8 endpointsAbility to Tolerate Lithium Carbonate
Time frame:28 weeks
concentration, descriptive
Ability to Tolerate Lithium Carbonate
Time frame:28 weeks
concentration, descriptive
Posted result
| Group | Value (number), Subject | Reported bounds |
|---|---|---|
| Lithium Carbonaten=14 Participants | 1 | - |
Study Drug Compliance
Time frame:28 weeks
descriptive
Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity
Time frame:28 weeks
change from baseline, improvement
Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline
Time frame:28 weeks
change from baseline, improvement
Study Drug Compliance
Time frame:28 weeks
descriptive
Posted result
| Group | Value (number), Subjects | Reported bounds |
|---|---|---|
| Lithium Carbonaten=14 Participants | 14 | - |
Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity
Time frame:28 weeks
change from baseline, improvement
Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline
Time frame:28 weeks
change from baseline, improvement
Provenance
Sources
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.