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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this trial is to evaluate the safety and tolerability of lithium in people with progressive supranuclear palsy or corticobasal degeneration.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Westat
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Lithium Carbonate

Criteria

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