NCT06946511 · Phase 1 · NOT YET RECRUITING

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

This trial is testing an experimental intravenous peptide called PMS-001 to see whether it can improve memory recall in people who already have moderate to severe dementia. Researchers are also checking safety across four dose levels. It is a Phase 1 trial, meaning the primary goal is establishing whether the drug is safe — it is very early stage and not proven or approved for anything.

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're excluded 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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-05-01

View full record on ClinicalTrials.gov

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