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

Last updated: April 28, 2025
Sponsor: Ruijin Hospital
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Dementia

Treatment

Placebo

Peptide PMS-001 Intravenous Injection

Clinical Study ID

NCT06946511
RuijinH-2025125
  • Ages 60-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, indicatingmoderate to severe dementia.

  3. Participants must provide written informed consent to participate in the study.

Exclusion

Exclusion Criteria:

  1. Presence of other neurological diseases that may cause cognitive decline, such ascerebrovascular 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 thecompletion 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 totwo or more medications, foods (such as milk), or pollen (excluding untreated,asymptomatic seasonal allergies), or known allergies to components of the study drugor similar agents.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
August 01, 2025
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

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