drugset / Trial / NCT06946511

Exploratory Study of the Effects of Peptide PMS-001 on Long-Delay Recall in Patients With Moderate to Severe Dementia

NCT06946511 ↗

Phase 1/2 Not yet recruiting 50 enrolled Ruijin Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a single-center, randomized, double-blind, placebo-controlled study. Patients will be randomly assigned to either the peptide intervention group (with dose escalation at 15mg, 30mg, 60mg, and 75mg) or the placebo control group. After learning and training, participants will receive an injection of PMS-001. The efficacy and safety of the intervention will be assessed at 1 hour, 1 day, 3 days, and 1 week post-intervention. This study aims to evaluate the effects of PMS-001 on improving long-delay recall in patients with moderate to severe dementia, as well as its safety profile.

Timeline

Start
2025-08-01
Primary completion
2026-01-31
Completion
2026-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject PMS-001 Peptide 15 mg Intravenous
Subject PMS-001 Peptide 30 mg Intravenous
Subject PMS-001 Peptide 60 mg Intravenous
Subject PMS-001 Peptide 75 mg Intravenous

Indications