Status:
RECRUITING
Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients
Lead Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- Age ≥50 and ≤85 on the date of signing the informed consent, males or females;
- BMI≥18kg/m2 and ≤32 kg/m2, weight ≥45 kg且≤100 kg at screening or baseline；
- must meet the diagnostic criteria for MCI due to AD or mild AD;
- The total score of HAMD-17 should be ≤10 scores at screening;
- The score of Hachinski ischemic scale should be ≤4 scores at screening;
- amyloid PET scan results from the central laboratory confirmed the presence of pathological changes in AD;
- Agreed to test ApoE genotype;
- Have a stable caregiver; where symptomatic drugs for AD is used, they must be stable for at least 1 months prior to the screening visit;
Exclusion
- Cognitive impairment of subjects due to other medical or neurological factors (other than AD);
- History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year;
- Any psychiatric diagnosis that may interfere with the subject's cognitive assessment;
- Cannot tolerate MRI or has contraindications to MRI, has significant lesions shown on MRI during screening, or has other conditions that the investigator believes may bring a significant risk to the subject;
- Patients who had severe trauma or had undergone surgery within 6 months prior to screening, or were scheduled to undergo surgery during the trial;
- History of moderate (3b) or severe renal failure or insufficiency;
- Uncontrolled hypertension: systolic blood pressure \> 160mmHg and diastolic blood pressure \>100mmHg during screening or baseline;
- 12-lead ECG showed QTcF \>450ms for male and \>470ms for female during screening;
- History of hypoglycemic coma or uncontrolled diabetes 6 months prior to the screening period;
- Thyroid dysfunction；
- Had unstable or clinically significant cardiovascular disease within 1 year prior to the screening period, had or currently has atrial fibrillation;
- History of malignancy within 5 years prior to screening;
- Patients with clinically significant systemic immunosuppression due to the persistent effects of immunosuppressive drugs;
- Human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody and hepatitis C virus antibody (HCV-Ab) were positive during screening.Hepatitis B active subjects \[Hepatitis B virus surface antigen (HBsAg) positive with HBV DNA \> upper limit of normal\]
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times ULN, or total bilirubin exceeding 2 times ULN
- Folic acid or vitamin B12 below the lower limit of normal
- coagulation disorders
- According to the investigators, the subjects were suicidal or had committed suicidal behaviour in the six months before the screening period;
- Severe visual or hearing impairment, unable to cooperate with the completion of the scale;
- A woman who is pregnant, or a woman of childbearing potential whose pregnancy test results are positive, or who is breastfeeding; or has a plan to have a child, unwilling or unable to take effective contraceptive measures within 30 days prior to the screening period or six months after the last use of the investigational drug.
- History of drug abuse or addiction;
- Three months prior to the randomization period or planned to use dual antiplatelet or anticoagulant drugs during the trial;
- Received any passive immunotherapy or other long-acting biologics used to prevent or delay cognitive decline within 3 months prior to screening;
- Investigators and relevant staff of the research Centre or others directly involved in programme implementation;
- The investigator considers that there are any circumstances that would cause the subject to be unable to complete the study or pose a significant risk to the subject or other factors that would interfere with the subject's ability to complete the study evaluation.
Key Trial Info
Start Date :
February 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 24 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06199037
Start Date
February 5 2024
End Date
June 24 2026
Last Update
April 9 2024
Active Locations (1)
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1
The First Affiliated hospital of USTC
Hefei, Anhui, China, 230000