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NOT YET RECRUITING
NCT06946511
PHASE1/PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

60 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-01

Completion Date

2026-01-31

Last Updated

2025-05-01

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (2)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China