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

NCT06946511 | Not Yet Recruiting Phase 1

• 1 other identifier: RuijinH-2025125
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

Dementia; Treatment

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of Peptide PMS-001 in improving long-delay recall in patients with moderate to severe dementia.

  The primary outcome will be specifically assessed using the sum of the long-delay recall scores from the following evaluation scales: The Auditory Verbal Learning Test - Huashan Version (AVLT-H): The long-delay recall score (AVL-LR) is the number of words correctly recalled after a 20-minute delay. The AVL-LR score ranges from 0 to 12, with higher scores indicating better memory performance and lower scores suggesting more significant memory impairment. Logical Memory Story A (LM-A) from the Wechsler Memory Scale - III (WMS-III): The long-delay recall score for LM-A measures the participant's ability to recall the story after a delay. The LM-A long-delay recall score ranges from 0 to 25, with higher scores indicating better memory function and lower scores pointing to memory deficits. The changes in participants' total scores, which are the sum of the long-delay recall scores from both AVLT-H and WMS-III LM-A, before and after treatment will be evaluated using these scales.

  Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.

Secondary Outcomes (5)

• Assessment of the impact of Peptide PMS-001 on overall cognitive function in patients with moderate to severe dementia

  Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.

• Assessment of the impact of Peptide PMS-001 on executive function in patients with moderate to severe dementia.

  Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.

• Assessment of the impact of Peptide PMS-001 on language function in patients with moderate to severe dementia.

  Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.

• Assessment of the impact of Peptide PMS-001 on visuospatial function in patients with moderate to severe dementia.

  Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.

• Assessment of the impact of Peptide PMS-001 on event-related potentials in patients with moderate to severe dementia.

  Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.

Study Arms (5)

PMS-001 Injection, 15mg

EXPERIMENTAL

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.

Drug: Peptide PMS-001 Intravenous Injection

PMS-001 Injection, 30mg

EXPERIMENTAL

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.

Drug: Peptide PMS-001 Intravenous Injection

PMS-001 Injection, 60mg

EXPERIMENTAL

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.

Drug: Peptide PMS-001 Intravenous Injection

PMS-001 Injection, 75mg

EXPERIMENTAL

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.

Drug: Peptide PMS-001 Intravenous Injection

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Peptide PMS-001 Intravenous Injection DRUG

Participants will receive intravenous injections of PMS-001.

PMS-001 Injection, 15mg; PMS-001 Injection, 30mg; PMS-001 Injection, 60mg; PMS-001 Injection, 75mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be aged 60 to 80 years (inclusive) at the time of screening, regardless of gender.
• Participants must have a Clinical Dementia Rating (CDR) total score \> 1, indicating moderate to severe dementia.
• Participants must provide written informed consent to participate in the study.

You may not qualify if:

• 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.
• Presence of metabolic diseases that may cause cognitive decline, such as anemia, thyroid dysfunction, folate and vitamin B12 deficiency, etc.
• Presence of severe psychiatric disorders, such as major depression.
• History of carbon monoxide poisoning.
• Presence of acute or severe life-threatening diseases.
• Presence of severe visual, auditory, or language impairments that would prevent the completion of neuropsychological assessments.
• Current use of psychotropic medications or a history of substance abuse.
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (2)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Chao Gao, MD, PhD

CONTACT

+86 18217590273; anshangaochao@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Director of the Department of Neurology, distinguished professor of the "Changjiang Scholars Program" of The Ministry of Education, doctoral supervisor

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 27, 2025
• Study Start: August 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

CN (2)