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Exploratory Study of the Effects of Peptide PMS-001 on Long-Delay Recall in Patients With Moderate to Severe Dementia
Lead sponsor
Asset
PMS-001
Listed sites
2
Recruiting sites
-
Enrollment
50
estimated
Study population
Mixed / unspecified dementia
Key I/E criterion
•Age 60-80
Primary endpoint
•Efficacy of Peptide PMS-001 in improving long-delay recall
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
3 endpointsAssessment 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.
Montreal Cognitive Assessment (MoCA)
descriptive
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.
descriptive
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.
time to event, event
Memory
1 endpointTo 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.
event count, event
Executive function / language
2 endpointsAssessment 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.
descriptive
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.
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.