A 6 Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear Palsy

Exclusion Criteria

• •1. Meets National Institute on Aging-Alzheimer's Association Workgroups criteria for probable AD (McKhann et al. 2011);
• •2. Any medical condition other than PSP that could account for cognitive deficits (e.g., active seizure disorder, stroke, vascular dementia);
• •3. A prominent and sustained response to levodopa therapy;
• •4. History of significant cardiovascular, hematologic, renal, or hepatic disease (or laboratory evidence thereof);
• •5. History of hypertension (repeated elevations in blood pressure exceeding 180 mm Hg systolic or 100 mm Hg diastolic; medical intervention indicated);
• •6. History of severe gastrointestinal bleed, or gastric or peptic ulcers;
• •7. History of aspirin triad (i.e., aspirin allergy, nasal polyps and asthma) or asthma;
• •8. History of major psychiatric illness or untreated depression;
• •9. Neutrophil count \<1,500/mm3, platelets \<100,000/mm3, serum creatinine \>1.5 x upper limit of normal (ULN), total bilirubin \>1.5 x ULN, alanine aminotransferase (ALT) \>3 x ULN, aspartate aminotransferase (AST) \>3 x ULN, or INR \>1.2 at Screening evaluations;
• •10. Evidence of any clinically significant findings on Screening or baseline evaluations which, in the opinion of the Investigator would pose a safety risk or interfere with appropriate interpretation of study data;
• •11. Current or recent history (within four weeks prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection;
• •13. Major surgery within four weeks prior to Screening;
• •14. Any contraindication to or unable to tolerate lumbar puncture at Screening, including use of anti-coagulant medications such as warfarin. Daily administration of 81 mg aspirin will be allowed as long as the dose is stable for 30 days prior to Screening;
• •15. Treatment with another investigational drug or participation in another interventional clinical trial within 3 months of Screening;
• •16. Chronic use of other NSAIDs or salicylates for any reason, except for daily baby aspirin (81 mg);
• •17. Concurrent treatment with thiazides or loop diuretics;
• •18. Concurrent use of oral corticosteroids or angiotensin-converting enzyme (ACE) inhibitors;
• •19. Treatment with any human blood product, including intravenous immunoglobulin, during the 6 months prior to Screening or during the trial;
• •20. Known hypersensitivity to the inactive ingredients in the study drug;
• •21. Pregnant or lactating;
• •22. Positive pregnancy test at Screening or Baseline (Day 1);
• •23. Cancer within 5 years of Screening, except for non-metastatic skin cancer or nonmetastatic prostate cancer not expected to cause significant morbidity or mortality within one year of Baseline.