Status:
COMPLETED
A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
Lead Sponsor:
Atridia Pty Ltd.
Conditions:
Alzheimer's Disease (AD)
Eligibility:
All Genders
55-85 years
Phase:
PHASE1
Brief Summary
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1707 in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD for 26 weeks.
Eligibility Criteria
Inclusion
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
- Male or female aged between 55 years and 85 years (inclusive) at the date of signed consent form.
- Total body weight of 45\~100 kg (inclusive), with a body mass index (BMI) of 19\~32 kg/m2 (inclusive)at screening or baseline.
- The subjects must meet the following clinical criteria for Mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or criteria for mild AD.
- The subjects should have a stable caregiver who will help the patients to participate in the whole study process.
Exclusion
- Cognitive impairment due to other medical or neurological factors (non-AD).
- History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year.
- Any psychiatric diagnosis that may interfere with the subject's cognitive assessment.
- Inability to tolerate MRI examination or have contraindications to MRI examination.
- 6\. Exclusion criteria related to previous or concomitant diseases, as listed in the protocol.
- 7\. Exclusion criteria related to general or laboratory tests, as listed in the protocol.
- 8\. The subject is suicidal according to the investigator's judgment or has committed suicidal behaviour within 6 months prior to the screening period.
- 9\. Severe visual or hearing impairment, unable to cooperate in the scale examination.
- 10\. Patients suspected to be allergic to Aβ antibody drugs and their excipients.
- 11\. Women who are pregnant, or women of childbearing age with positive pregnancy test results or are lactating.
- 12\. History of drug abuse and/or drug addiction within 1 year prior to screening.
- 13 Use of dual antiplatelet or anticoagulant drugs within 3 months prior to the randomization period or planned during the trial.
- Have had prior treatment with an anti-amyloid immunotherapy within 1 year prior to randomization.
- 15\. Those who have participated in a clinical trial of any drug or medical device within 3 months prior to screening.
- 16\. Investigators and site-related personnel or other persons directly involved in the implementation of the protocol.
- 17\. Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.
Key Trial Info
Start Date :
April 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2025
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06114745
Start Date
April 17 2024
End Date
July 8 2025
Last Update
July 11 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Liverpool Hospital
Sydney, New South Wales, Australia
2
Southern Neurology
Sydney, New South Wales, Australia
3
Austin Health
Melbourne, Victoria, Australia