Status:
NOT_YET_RECRUITING
Exploratory Study of the Effects of Peptide PMS-001 on Long-Delay Recall in Patients With Moderate to Severe Dementia
Lead Sponsor:
Ruijin Hospital
Conditions:
Dementia
Eligibility:
All Genders
60-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06946511
Start Date
August 1 2025
End Date
January 31 2026
Last Update
May 1 2025
Active Locations (2)
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1
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
2
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025