Phase
Condition
Dementia
Alzheimer's Disease
Memory Loss
Treatment
SHR-1707 placebo
SHR-1707
Clinical Study ID
Ages 55-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥55and ≤85 on the date of signing the informed consent, males or females;
BMI≥19kg/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 and baseline;
The score of Hachinski ischemic scale should be ≤4 scores at screening and baseline;
Qualitative amyloid PET scan results from the central laboratory confirmed thepresence of pathological changes in AD;
Agreed to test ApoE genotype;
Have a stable caregiver; where symptomatic drugs for AD is used, they must be stablefor at least 3 months prior to the baseline visit;
Exclusion
Exclusion Criteria:
Cognitive impairment of subjects due to other medical or neurological factors (otherthan AD);
History of stroke or transient ischemic attack, seizures, or other unexplained lossof consciousness within the past year;
Any psychiatric diagnosis that may interfere with the subject's cognitiveassessment;
Cannot tolerate MRI or has contraindications to MRI, has significant lesions shownon MRI during screening, or has other conditions that the investigator believes maybring a significant risk to the subject;
Suspected allergy to Aβ antibody drugs and excipients.
Patients who had severe trauma or had undergone surgery within 6 months prior toscreening, 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 bloodpressure >100mmHg in supine position 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 thescreening period;
Thyroid dysfunction;
Had unstable or clinically significant cardiovascular disease within 1 year prior tothe 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 thepersistent effects of immunosuppressive drugs;
Human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody andhepatitis C virus antibody (HCV-Ab) were positive during screening.Hepatitis Bactive subjects [Hepatitis B virus surface antigen (HBsAg) positive with HBV DNA >upper limit of normal]
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 timesULN, 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 suicidalbehavior in the six months before the screening period;
Severe visual or hearing impairment, unable to cooperate with the completion of thescale;
A woman who is pregnant, or a woman of childbearing potential whose pregnancy testresults 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 tothe 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 antiplateletor anticoagulant drugs during the trial;
Received any passive immunotherapy or other long-acting biologics used to prevent ordelay cognitive decline within 1 year prior to screening;
Investigators and relevant staff of the research Centre or others directly involvedin programme implementation;
The investigator considers that there are any circumstances that would cause thesubject to be unable to complete the study or pose a significant risk to the subjector other factors that would interfere with the subject's ability to complete thestudy evaluation.
Study Design
Connect with a study center
The First Affiliated Hospital Of USTC
Hefei, Anhui 230001
ChinaSite Not Available
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