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

Launched by RUIJIN HOSPITAL · Apr 18, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called PMS-001 to see if it can help improve memory recall in patients with moderate to severe dementia. The study will involve giving participants either the PMS-001 injection or a placebo (which looks like the treatment but has no active ingredients) to see how effective and safe the drug is. Participants will be closely monitored at different times after the injection—one hour, one day, three days, and one week later—to track any changes in their memory.

To be eligible for this trial, participants need to be between 60 and 80 years old and have a certain level of dementia as assessed by a rating scale. They must also be able to give written consent to participate. However, individuals with other serious brain or health conditions, certain metabolic diseases, or severe psychiatric disorders are not eligible. If you or a loved one is considering participating in this study, you can expect a thorough assessment and care throughout the trial, and it’s a chance to contribute to research that may help future dementia treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants must be aged 60 to 80 years (inclusive) at the time of screening, regardless of gender.
• • 2. Participants must have a Clinical Dementia Rating (CDR) total score \> 1, indicating moderate to severe dementia.
• • 3. Participants must provide written informed consent to participate in the study.
• Exclusion Criteria:
• • 1. Presence of other neurological diseases that may cause cognitive decline, such as cerebrovascular disease, encephalitis, brain tumors, traumatic brain injury, epilepsy, Parkinson's disease, etc.
• • 2. Presence of metabolic diseases that may cause cognitive decline, such as anemia, thyroid dysfunction, folate and vitamin B12 deficiency, etc.
• • 3. Presence of severe psychiatric disorders, such as major depression.
• • 4. History of carbon monoxide poisoning.
• • 5. Presence of acute or severe life-threatening diseases.
• • 6. Presence of severe visual, auditory, or language impairments that would prevent the completion of neuropsychological assessments.
• • 7. Current use of psychotropic medications or a history of substance abuse.
• • 8. Individuals with specific allergy histories, or those with a history of allergies to two or more medications, foods (such as milk), or pollen (excluding untreated, asymptomatic seasonal allergies), or known allergies to components of the study drug or similar agents.