ANAVEX3-71 for Schizophrenia
(SZ-001 Trial)
Trial Summary
What is the purpose of this trial?
A study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and electrophysiology of ANAVEX3-71 in patients with Schizophrenia.
Will I have to stop taking my current medications?
You will need to stay on your current antipsychotic medications if they are second-generation types, except for clozapine, which is not allowed. You can use quetiapine for sleep at doses less than 300 mg, but not during the day.
How is the drug ANAVEX3-71 different from other schizophrenia treatments?
ANAVEX3-71 is unique because it targets alpha7-nicotinic acetylcholine receptors, which are often deficient in people with schizophrenia. This mechanism may help improve cognitive and sensory processing deficits associated with the condition, offering a novel approach compared to traditional antipsychotics.12345
Eligibility Criteria
Adults aged 18-50 with stable schizophrenia, on consistent antipsychotic medication for at least 6 weeks, and a BMI between 18.5 to 40 kg/m2 can join this trial. They must have a specific cognition score, not be drug or alcohol users, and agree to stay inpatient as required. Pregnant individuals or those with recent investigational drug use are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Part A: Multiple Ascending Dose
Participants receive multiple ascending doses of ANAVEX3-71 for dose selection, safety, and pharmacokinetics assessment
Part B: Double-Blind, Placebo-Controlled
Participants receive either ANAVEX3-71 or placebo to assess exploratory efficacy and continued repeat-dose safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ANAVEX3-71
Find a Clinic Near You
Who Is Running the Clinical Trial?
Anavex Life Sciences Corp.
Lead Sponsor
Hassman Research Institute
Collaborator
Cognitive Research Corporation
Industry Sponsor
COGNISION
Collaborator