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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00703677
• Date of registration: 20/06/2008
• Prospective Registration: Yes
• Primary sponsor: Westat
• Public title: A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration
• Scientific title: A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration
• Date of first enrolment: September 2008
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00703677
• Study type: Interventional
• Phase: Phase 1/Phase 2

Countries of recruitment

United Kingdom, United States

Contacts

• Name: Renè Gonin, PhD
• Affiliation: (Math. Stats.), Westat

Key inclusion & exclusion 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-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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Corticobasal Degeneration

Progressive Supranuclear Palsy

Intervention(s)

Drug: Lithium

Primary Outcome(s)

Ability to Tolerate Lithium Carbonate [Time Frame: 28 weeks]

Secondary Outcome(s)

Geriatric Depression Scale(GDS)-15:Change From Baseline [Time Frame: 28 weeks]

Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF) [Time Frame: 28 weeks]

Study Drug Compliance [Time Frame: 28 weeks]

Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF [Time Frame: 28 weeks]

Frontal Assessment Battery (FAB): Change From Baseline [Time Frame: 28 weeks]

Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline [Time Frame: 28 weeks]

PSP Rating Scale Score: Change From Baseline [Time Frame: 28 weeks]

Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity [Time Frame: 28 weeks]

PSP-Quality of Life Scale (QoL):Change From Baseline [Time Frame: 28 weeks]

Secondary ID(s)

HHSN265200423611C

NPTUNE_PSP_CBD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)

Results

• Results available: Yes
• Date Posted: 11/06/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00703677