Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are progressive, adult-onset neurodegenerative disorders characterized by the accumulation of hyperphosphorylated tau. Symptomatic treatment is of minimal benefit to individuals with PSP or CBD, and there are no effective disease modifying agents. Tau phosphorylation is regulated in part by the enzyme GSK-3β (glycogen synthase kinase-3 beta ). Inhibition of this enzyme may benefit individuals with PSP or CBD by decreasing the levels of phosphorylated tau. Lithium is known to inhibit GSK-3β and, thus, may be a rational therapeutic approach. The primary objective of this study is to determine the safety and tolerability of lithium in people with PSP or CBD. Additionally, this study will evaluate potential biomarkers and clinical outcome measures as well as assess study drug compliance. In this multicenter, open label study, 45 eligible participants with PSP or CBD will receive the study drug, lithium. The dosage of lithium will be titrated over a 5-week period, and participants will then be followed prospectively for 6 months. Participants will be evaluated at the screening visit, baseline visit, and weeks 2 and 5 during the titration phase. Clinic study visits will then occur on alternate months through week 28. Telephone visits will occur between clinic study visits. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00703677
Study type Interventional
Source Westat
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2008
Completion date January 2010

See also
  Status Clinical Trial Phase
Completed NCT04096651 - Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy N/A
Recruiting NCT02194816 - Modifiable Variables in Parkinsonism (MVP)
Completed NCT00382824 - Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP) N/A
Completed NCT04184063 - Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA) Phase 2
Recruiting NCT04706234 - Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies
Recruiting NCT04472130 - Neurodegenerative Diseases Registry
Recruiting NCT04139551 - Oxford Study of Quantification in Parkinsonism
Completed NCT02734485 - Deep TMS for the Treatment of Patients With Parkinson's Disease and Progressive Supranuclear Palsy N/A
Completed NCT01110720 - Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy Phase 2/Phase 3
Completed NCT01174771 - Repetitive Transcranial Magnetic Stimulation (TMS) for Progressive Supranuclear Palsy and Corticobasal Degeneration N/A
Completed NCT00465790 - Research of Biomarkers in Parkinson Disease Phase 0
Completed NCT02460094 - Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy Phase 1
Active, not recruiting NCT04993768 - A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP) Phase 2
Recruiting NCT03225144 - Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Completed NCT03058965 - Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain Early Phase 1
Recruiting NCT02605785 - A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy N/A
Completed NCT01353183 - Analysis of the Enteric Nervous System Using Colonic Biopsies N/A
Completed NCT00385710 - Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine) Phase 2
Recruiting NCT05260151 - Tau Protein and SV2a Imaging in Patients With Tau Protein-related Diseases
Active, not recruiting NCT04658199 - A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy Phase 1