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

Обзор

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.

Вмешательства

• Препарат Peptide PMS-001 Intravenous Injection
  Participants will receive intravenous injections of PMS-001.
• Препарат Placebo
  The control group will receive a placebo, which is the blank excipient (mannitol) of the injectable PMS-001.

Первичные конечные точки

• To evaluate the efficacy of Peptide PMS-001 in improving long-delay recall in patients with moderate to severe dementia. [Срок оценки: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.]

Вторичные конечные точки (5)

• Assessment of the impact of Peptide PMS-001 on overall cognitive function in patients with moderate to severe dementia [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

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

Идентификаторы

NCT: NCT06946511 · RuijinH-2025125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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