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

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Dementia

Treatments: Drug: Placebo; Drug: Peptide PMS-001 Intravenous Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06946511

RuijinH-2025125

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 5 patient groups, including a placebo group

PMS-001 Injection, 15mg

Experimental group

Description:

Participants in this group will receive an injection of PMS-001 at a dose of 15mg. This group is designed to evaluate the efficacy and safety of PMS-001 at the lowest dose level.

Treatment:

Drug: Peptide PMS-001 Intravenous Injection

PMS-001 Injection, 30mg

Experimental group

Description:

Participants in this group will receive an injection of PMS-001 at a dose of 30mg. This group is designed to evaluate the efficacy and safety of PMS-001 at a moderate dose level.

Treatment:

Drug: Peptide PMS-001 Intravenous Injection

PMS-001 Injection, 60mg

Experimental group

Description:

Participants in this group will receive an injection of PMS-001 at a dose of 60mg. This group is designed to evaluate the efficacy and safety of PMS-001 at a higher dose level.

Treatment:

Drug: Peptide PMS-001 Intravenous Injection

PMS-001 Injection, 75mg

Experimental group

Description:

Participants in this group will receive an injection of PMS-001 at a dose of 75mg. This group is designed to evaluate the efficacy and safety of PMS-001 at the highest dose level.

Treatment:

Drug: Peptide PMS-001 Intravenous Injection

Placebo

Placebo Comparator group

Description:

Participants in this group will receive an injection of placebo. This group serves as a control to compare the effects of PMS-001 on long-delay recall and safety in patients with moderate to severe dementia.

Treatment:

Drug: Placebo