Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients (NCT06199037) | Clinical Trial Compass
TerminatedPhase 2
Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients
Stopped: Based on the adjustment of the sponsor's R\&D strategy, it is decided to terminate this study in advance.
China46 participantsStarted 2024-02-05
Plain-language 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.
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in intracerebral Aβ deposition at Week 26 as assessed by brain Aβ PET
. 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;