A Study of SHR-1707 With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's… (NCT05681819) | Clinical Trial Compass
CompletedPhase 1
A Study of SHR-1707 With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
China33 participantsStarted 2023-02-17
Plain-language summary
This study aims 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.
Who can participate
Age range55 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age ≥ 55 and ≤ 85 on the date of signing the informed consent, males or females;
✓. BMI ≥ 19 kg/m2 and ≤ 32 kg/m2, weight ≥ 45 kg and ≤ 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 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 3 months prior to the baseline 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;
What they're measuring
1
To assess the number of patients with adverse events (AEs)
Timeframe: Week 26
2
To assess the number of patients with clinically significant change from baseline in vital signs values
Timeframe: Week 26
3
To assess the number of patients with clinically significant change in physical examination
Timeframe: Week 26
4
To assess the number of patients with clinically significant change from baseline in laboratory examination
Timeframe: Week 26
5
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Timeframe: Week 26
6
To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)
✕. Suspected allergy to Aβ antibody drugs and excipients;
✕. 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 \> 160 mmHg and diastolic blood pressure \>100 mmHg in supine position during screening or baseline;