RecruitingPhase 2NCT06199037

Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of SHR-1707 In Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease


Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Enrollment

45 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of SHR-1707 In Patients with Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and early effectiveness of a new drug called SHR-1707 for people in the early stages of Alzheimer's disease. SHR-1707 targets amyloid plaques — the abnormal protein deposits in the brain that are a key feature of Alzheimer's. **You may be eligible if...** - You are 50–85 years old - You have been diagnosed with mild cognitive impairment (early memory problems) or mild Alzheimer's disease - A PET brain scan has confirmed the presence of amyloid plaques - Your depression score is low (HAMD-17 ≤10) - Your BMI is between 18 and 32, and you weigh between 45–100 kg **You may NOT be eligible if...** - You have moderate or severe Alzheimer's disease - You do not have confirmed amyloid changes on brain PET scan - You have significant depression or other serious psychiatric conditions - You are outside the weight or BMI range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-1707

1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 injection

DRUGSHR-1707 placebo

1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 placebo injection


Locations(1)

The First Affiliated hospital of USTC

Hefei, Anhui, China

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NCT06199037


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