Progressive Supranuclear Palsy Clinical Trial
Official title:
A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration
The goal of this trial is to evaluate the safety and tolerability of lithium in people with progressive supranuclear palsy or corticobasal degeneration.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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