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

Phase 2Not Yet RecruitingNCT06946511

Ruijin Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dementia

Interventions

Peptide PMS-001 Intravenous Injection

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

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

Outcomes

Primary Outcomes

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.