A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

Phase 1

Recruiting

• Conditions: Alzheimer's Disease (AD)

• Registration Number: NCT06114745
• Lead Sponsor: Atridia Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-11
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Ability to understand the trial procedures and possible adverse events, voluntarily<br> participate in the trial,<br><br> 2. Male or female aged between 55 years and 85 years (inclusive) at the date of signed<br> consent form.<br><br> 3. Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~32<br> kg/m2 (inclusive)at screening or baseline.<br><br> 4. The subjects must meet the following clinical criteria for Mild cognitive impairment<br> (MCI) due to Alzheimer's Disease (AD) or criteria for mild AD.<br><br> 5. The subjects should have a stable caregiver who will help the patients to<br> participate in the whole study process.<br><br>Exclusion Criteria:<br><br> 1. Cognitive impairment due to other medical or neurological factors (non-AD).<br><br> 2. History of stroke or transient ischemic attack, seizures, or other unexplained loss<br> of consciousness within the past 1 year.<br><br> 3. Any psychiatric diagnosis that may interfere with the subject's cognitive<br> assessment.<br><br> 4. Inability to tolerate MRI examination or have contraindications to MRI examination.<br><br> 6. Exclusion criteria related to previous or concomitant diseases, as listed in the<br> protocol.<br><br> 7. Exclusion criteria related to general or laboratory tests, as listed in the<br> protocol.<br><br> 8. The subject is suicidal according to the investigator's judgment or has committed<br> suicidal behaviour within 6 months prior to the screening period.<br><br> 9. Severe visual or hearing impairment, unable to cooperate in the scale examination.<br><br> 10. Patients suspected to be allergic to Aß antibody drugs and their excipients.<br><br> 11. Women who are pregnant, or women of childbearing age with positive pregnancy test<br> results or are lactating.<br><br> 12. History of drug abuse and/or drug addiction within 1 year prior to screening.<br><br>13 Use of dual antiplatelet or anticoagulant drugs within 3 months prior to the<br>randomization period or planned during the trial.<br><br>14.Have had prior treatment with an anti-amyloid immunotherapy within 1 year prior to<br>randomization.<br><br> 15. Those who have participated in a clinical trial of any drug or medical device within<br> 3 months prior to screening.<br><br> 16. Investigators and site-related personnel or other persons directly involved in the<br> implementation of the protocol.<br><br> 17. Other unspecified reasons that, in the opinion of the investigator or sponsor, make<br> the subject unsuitable for enrolment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events(AEs);Baseline in vital signs value;Physical examination;Laboratory examination;Baseline in 12-ECG values;MRI

Secondary Outcome Measures

Name	Time	Method
Aß positron emission tomography (PET);Concentrations of SHR-1707;Anti-Drug antibody