Title
A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 on Cerebrospinal Fluid Biomarkers in 36 Patients With Progressive Supranuclear Palsy
Phase
Phase 2Lead Sponsor
AlzProtect SASStudy Type
InterventionalStatus
Active, not recruitingIndication/Condition
Progressive Supranuclear PalsyIntervention/Treatment
AZP2006 oral solution ...Study Participants
36A phase 2 study to assess tolerability, safety, pharmacokinetics and effect of AZP2006 at different doses versus placebo on cerebrospinal fluid biomarkers in 36 patients with progressive supranuclear palsy. The patient study duration is 29 weeks including a washout period.
Once daily intake in the morning
Once daily intake in the morning
Patients randomized in this arm will receive 60 mg of study investigational drug AZP2006 once daily during 84 days.
Patients randomized in this arm will receive 80 mg of study investigational drug AZP2006 once daily during 10 days followed by 50 mg of study investigational drug AZP2006 once daily during the next 74 days.
Patients randomized in this arm will receive placebo solution once daily during 84 days.
Inclusion Criteria: Male and female patients with probable or possible PSP Patients must be stable with their medication for at least 30 days prior to the inclusion visit. Exclusion Criteria: Any history of clinically significant head trauma or cerebrovascular disease or recent history of substance abuse or alcohol abuse and deemed to be clinically significant by the Investigator. History of deep brain stimulator (DBS) surgery other than sham surgery for DBS clinical study.
