NCT06199037招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change from baseline in intracerebral Aβ deposition at Week 26 as assessed by brain Aβ PET
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
SHR-1707
Experimental
干预措施: SHR-1707 (Drug)
SHR-1707 placebo
Placebo Comparator
干预措施: SHR-1707 placebo (Drug)
结局指标
主要结局
Change from baseline in intracerebral Aβ deposition at Week 26 as assessed by brain Aβ PET
时间窗: Week 26
次要结局
- To assess the ADA(week 26)
- To assess the number of patients with clinically significant change from baseline in 12-ECG values,(week 52\week 78)
- To assess the number of patients with clinically significant change from baseline in 12-ECG values(week 26)
- To assess the number of patients with clinically significant change in Head brain MRI(week 52\week 78)
- To assess the number of patients with adverse events (AEs)(week 52\week 78)
- To assess the number of patients with clinically significant change from baseline in vital signs values(week 52\week 78)
- To assess the number of patients with clinically significant change in physical examination(week 52\week 78)
- To assess the number of patients with clinically significant change from baseline in laboratory examination(week 52\week 78)
- To assess the number of patients with clinically significant change in brain MRI(week 26)
研究者
研究点 (1)
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