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
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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;
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;