- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06199037
Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients
April 6, 2024 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hongyan Qiu
- Phone Number: 18817821303
- Email: hongyan.qiu@hengrui.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230000
- Recruiting
- The First Affiliated Hospital of Ustc
-
Principal Investigator:
- Jiong Shi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR-1707
|
1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 injection
|
Placebo Comparator: SHR-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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in intracerebral Aβ deposition at Week 26 as assessed by brain Aβ PET
Time Frame: Week 26
|
Week 26
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the number of patients with adverse events (AEs)
Time Frame: week 26
|
week 26
|
To assess the number of patients with clinically significant change from baseline in vital signs values
Time Frame: week 26
|
week 26
|
To assess the number of patients with clinically significant change in physical examination
Time Frame: week 26
|
week 26
|
To assess the number of patients with clinically significant change from baseline in laboratory examination
Time Frame: week 26
|
week 26
|
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Time Frame: week 26
|
week 26
|
To assess the number of patients with clinically significant change in brain MRI
Time Frame: week 26
|
week 26
|
To assess the ADA
Time Frame: week 26
|
week 26
|
To assess the number of patients with adverse events (AEs)
Time Frame: week 52\week 78
|
week 52\week 78
|
To assess the number of patients with clinically significant change from baseline in vital signs values
Time Frame: week 52\week 78
|
week 52\week 78
|
To assess the number of patients with clinically significant change in physical examination
Time Frame: week 52\week 78
|
week 52\week 78
|
To assess the number of patients with clinically significant change from baseline in laboratory examination
Time Frame: week 52\week 78
|
week 52\week 78
|
To assess the number of patients with clinically significant change from baseline in 12-ECG values,
Time Frame: week 52\week 78
|
week 52\week 78
|
To assess the number of patients with clinically significant change in Head brain MRI
Time Frame: week 52\week 78
|
week 52\week 78
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2024
Primary Completion (Estimated)
April 30, 2025
Study Completion (Estimated)
June 24, 2026
Study Registration Dates
First Submitted
December 27, 2023
First Submitted That Met QC Criteria
December 27, 2023
First Posted (Actual)
January 10, 2024
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 6, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1707-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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