Status:
COMPLETED
A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration
Lead Sponsor:
Westat
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Progressive Supranuclear Palsy
Corticobasal Degeneration
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this trial is to evaluate the safety and tolerability of lithium in people with progressive supranuclear palsy or corticobasal degeneration.
Detailed Description
Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are progressive, adult-onset neurodegenerative disorders characterized by the accumulation of hyperphosphorylated tau. Symptoma...
Eligibility Criteria
Inclusion
- Able to give informed consent
- Able to comply with the study protocol, including ability to attend follow-up study visits for the duration of the study
- Diagnosis of PSP or CBD based on the following criteria:
- 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
- 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)
- 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
- 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.
- Creatinine clearance \> 50 ml/min
- Able to take oral medication
- 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.)
- Able to identify a study partner
Exclusion
- Evidence of other diseases that could explain the clinical presentation
- History of known sensitivity or intolerability to lithium or to other known ingredients in the study drug
- Exposure to any investigational agent within 28 days of the screening visit
- Clinically significant cardiac disease or EKG findings
- 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)
- Moderate to severe ongoing depression
- Family history of "PSP" or "CBS"
- Clinically significant abnormalities on the screening visit laboratory results
- Any AE ≥ Grade 3 as listed on the CTCAE, version 3.0
- Women who are pregnant or breastfeeding
- History of brain surgery
- Use of other potential GSK-3β inhibitors (e.g., valproic acid)
- Use of iodide salts \[e.g., calcium iodide, hydrogen iodide (hydriodic acid), iodide, iodinated glycerol (Organidin), iodine, potassium iodide (SSKI), and sodium iodide\]
- Previous use of lithium
- 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
- Active psoriasis
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00703677
Start Date
September 1 2008
End Date
January 1 2010
Last Update
May 17 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern University
Chicago, Illinois, United States, 60611
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
University of Louisville
Louisville, Kentucky, United States, 40202
4
University of Maryland
Baltimore, Maryland, United States, 21201