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

NCT ID: NCT06946511

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PMS-001 Injection, 15mg

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.

Group Type: EXPERIMENTAL

Peptide PMS-001 Intravenous Injection

Intervention Type: DRUG

Participants will receive intravenous injections of PMS-001.

PMS-001 Injection, 30mg

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.

Group Type: EXPERIMENTAL

Peptide PMS-001 Intravenous Injection

Intervention Type: DRUG

Participants will receive intravenous injections of PMS-001.

PMS-001 Injection, 60mg

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.

Group Type: EXPERIMENTAL

Peptide PMS-001 Intravenous Injection

Intervention Type: DRUG

Participants will receive intravenous injections of PMS-001.

PMS-001 Injection, 75mg

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.

Group Type: EXPERIMENTAL

Peptide PMS-001 Intravenous Injection

Intervention Type: DRUG

Participants will receive intravenous injections of PMS-001.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The control group will receive a placebo, which is the blank excipient (mannitol) of the injectable PMS-001.

Interventions

Peptide PMS-001 Intravenous Injection

Participants will receive intravenous injections of PMS-001.

Intervention Type: DRUG

Placebo

The control group will receive a placebo, which is the blank excipient (mannitol) of the injectable PMS-001.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

liu jun

Chief Physician, Director of the Department of Neurology, distinguished professor of the "Changjiang Scholars Program" of The Ministry of Education, doctoral supervisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

China

Central Contacts

Chao Gao, MD, PhD

Role: CONTACT

anshangaochao@163.com

+86 18217590273

Facility Contacts

Chao Gao, MD，PhD

Role: primary

anshangaochao@163.com

+86 18217590273

Other Identifiers

RuijinH-2025125

Identifier Type: -

Identifier Source: org_study_id