NCT06946511

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia

Interventions

Type	Name	Description
DRUG	Peptide PMS-001 Intravenous Injection	Participants will receive intravenous injections of PMS-001.
DRUG	Placebo	The control group will receive a placebo, which is the blank excipient (mannitol) of the injectable PMS-001.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2025-04-27
• Last updated: 2025-05-01

Locations

2 sites across 1 country: China