A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
NCT ID: NCT06114745
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
2 participants
INTERVENTIONAL
2024-04-17
2025-07-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects
NCT04745104
Safety, Tolerability and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients.
NCT05681819
Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients
NCT06199037
A Study of SHR-1707 in Healthy Young Adult and Elderly Subjects
NCT04973189
A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease
NCT04491006
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose level 1 SHR-1707
SHR-1707 is administered intravenously.
SHR-1707 injection
Drug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion
Dose level 1 Placebo
Placebo is administered intravenously.
Placebo
Placebo will be administered through IV infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
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.
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.
55 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Atridia Pty Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Liverpool Hospital
Sydney, New South Wales, Australia
Southern Neurology
Sydney, New South Wales, Australia
Austin Health
Melbourne, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHR-1707-103
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.