Progressive Supranuclear Palsy Clinical Trial
Official title:
A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration
Verified date | April 2024 |
Source | Westat |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this trial is to evaluate the safety and tolerability of lithium in people with progressive supranuclear palsy or corticobasal degeneration.
Status | Completed |
Enrollment | 17 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | 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-3ß 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Newcastle University | Newcastle upon Tyne | |
United States | University of Maryland | Baltimore | Maryland |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Louisville | Louisville | Kentucky |
United States | UMDNJ Robert Wood Johnson Medical School | New Brunswick | New Jersey |
United States | Beth Israel Medical Center | New York | New York |
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Westat | National Institute of Neurological Disorders and Stroke (NINDS) |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability to Tolerate Lithium Carbonate | The ability to complete the study period on lithium at a serum concentration of at least 0.4 mEq/L. | 28 weeks | |
Secondary | Study Drug Compliance | Subjects receiving 80% or more of the prescribed doses between study visits were considered compliant. | 28 weeks | |
Secondary | Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF) | Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are characterized by hyperphosphorylation of tau. Lithium inhibits one of the kinases (GSK-3 beta) that phosphorylates tau; levels of tau phosphorylation will be measured at baseline and at Week 28. | 28 weeks | |
Secondary | Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF | With inhibition of Glycogen Synthase Kinase (GSK)-3 beta, levels of BDNF may increase. BDNF levels will be measured at baseline and at Week 28. | 28 weeks | |
Secondary | Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity | Levels of beta-catenin and the ratio of phosphorylated GSK-3 beta to total GSK-3 beta will be measured at baseline and at Week 28 | 28 weeks | |
Secondary | PSP Rating Scale Score: Change From Baseline | The PSP Rating Scale is a 28-item scale designed to assess the disability associated with PSP. The six functional categories assessed are: daily activities, behavior, bulbar function, oculomotor function, limb motor function, and gait/midline function. Subjects will be assessed at baseline and Weeks 12, 20, and 28. | 28 weeks | |
Secondary | Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline | The UPDRS is a commonly used clinical rating scale to assess motor function in patients with parkinsonism. Subjects will be assessed at baseline and Weeks 5, 12, 20, and 28. | 28 weeks | |
Secondary | PSP-Quality of Life Scale (QoL):Change From Baseline | The PSP-QoL Scale is an instrument designed to assess mental and physical aspects of quality of life specifically in patients with PSP. Subjects will be assessed at baseline and Weeks 12, 20, and 28. | 28 weeks | |
Secondary | Frontal Assessment Battery (FAB): Change From Baseline | The FAB is a brief, 6-item instrument designed to assess executive function. Subjects will be assessed at baseline and at Week 28. | 28 weeks | |
Secondary | Geriatric Depression Scale(GDS)-15:Change From Baseline | The GDS-15 is a 15-item instrument used to screen for depression in the elderly. Subjects will be assessed at the Screening Visit and at Week 28. | 28 weeks |
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