Not yet recruiting NCT06946511
Exploratory Study of the Effects of Peptide PMS-001 on Long-Delay Recall in Patients With Moderate to Severe Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peptide PMS-001 Intravenous Injection, Placebo.
- Who it may be relevant to
- Registry conditions: Dementia. Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug Peptide PMS-001 Intravenous Injection
Participants will receive intravenous injections of PMS-001. - Drug Placebo
The control group will receive a placebo, which is the blank excipient (mannitol) of the injectable PMS-001.
Primary outcome measures
- To evaluate the efficacy of Peptide PMS-001 in improving long-delay recall in patients with moderate to severe dementia. [Time frame: 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 outcome measures (5)
- Assessment of the impact of Peptide PMS-001 on overall cognitive function in patients with moderate to severe dementia [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Clinical assessments will be conducted at baseline, and then at 1 hour, 1 day, 3 days, and 1 week after administration of the intervention.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06946511 · RuijinH-2025125