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

Alzheimer's Disease (AD) Clinical Trial

Official title:

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of SHR-1707 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06114745
• Other study ID #: SHR-1707-103
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 17, 2024
• Est. completion date: November 7, 2025

Study information

• Verified date: March 2024
• Source: Atridia Pty Ltd.
• Contact: Kathy You
• Phone: +61 02 9299 0433
• Email: kathyyou[@]atridia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: November 7, 2025
• Est. primary completion date: November 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,

2. Male or female aged between 55 years and 85 years (inclusive) at the date of signed consent form.

3. Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~32 kg/m2 (inclusive)at screening or baseline.

4. The subjects must meet the following clinical criteria for Mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or criteria for mild AD.

5. The subjects should have a stable caregiver who will help the patients to participate in the whole study process.

Exclusion Criteria:

1. Cognitive impairment due to other medical or neurological factors (non-AD).

2. History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year.

3. Any psychiatric diagnosis that may interfere with the subject's cognitive assessment.

4. 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 Aß 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. 14.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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease (AD)
• Cognitive Dysfunction

Intervention

Drug:
• SHR-1707 injection
Drug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion
• Placebo
Placebo will be administered through IV infusion

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria
Australia	Liverpool Hospital	Sydney	New South Wales
Australia	Southern Neurology	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Atridia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events(AEs)	To assess the number of patients with adverse events	week 26
Primary	Baseline in vital signs value	To assess the number of patients with clinically significant change from baseline in vital signs value	week 26
Primary	Physical examination	To assess the number of patients with clinically significant change in physical examination	week 26
Primary	Laboratory examination	To assess the number of patients with clinically significant change from baseline in laboratory examination	week 26
Primary	Baseline in 12-ECG values	To assess the number of patients with clinically significant change from baseline in 12-ECG values	week 26
Primary	MRI	To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)	week 26
Secondary	Aß positron emission tomography (PET)	To assess the change from baseline in intracerebral Aß deposition as measured by brain Aß positron emission tomography (PET)	week 26
Secondary	Concentrations of SHR-1707	To assess concentrations of SHR-1707 after multiple doses of administration	week 26
Secondary	Anti-Drug antibody	To assess the incidence and time of occurrence of anti-SHR-1707 antibodies	week 26