drugset / Trial / NCT06185543

A Phase 2, Randomized, Prospective Double-Blind, Single-Center, Placebo-controlled Study to Evaluate Safety, Tolerability, Target Engagement, and Efficacy of PrimeC in Patients With Mild to Moderate Alzheimer's Disease.

NCT06185543

Phase 2 Terminated 8 enrolled NeuroSense Therapeutics Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

20 subjects with mild to moderate AD will be enrolled in the study and randomized at a 1:1 ratio to receive the study drug or placebo tablets, respectively. All subjects will be administered the drug/placebo twice daily (BID), two tablets each time, for 52 weeks. Subjects will be allowed to receive standard of care (SOC) treatment of approved products or their combination. Subjects will be evaluated every 3 months for safety and tolerability.

Timeline

Start
2023-11-19
Primary completion
2025-09-30
Completion
2025-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 136 mg Oral
Comparator Ciprofloxacin Small molecule 1360 mg Oral

Indications