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A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
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
Lead sponsor
Asset
SHR-1707
Listed sites
3
Recruiting sites
-
Enrollment
2
actual
Study population
Alzheimer’s disease, MCI / preclinical Alzheimer’s
Key I/E criteria
•Alzheimer's disease•Study partner/caregiver required•MRI contraindications excluded
Primary endpoints
•Adverse events(AEs)•Baseline in vital signs value•Physical examination
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 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.
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Neuroimaging
1 endpointMRI
Time frame:week 26
change from baseline, improvement
Safety / tolerability / PK
2 endpointsAdverse events(AEs)
Time frame:week 26
event count, event
Baseline in vital signs value
Time frame:week 26
change from baseline, event
Other (unclassified)
6 endpointsPhysical examination
Time frame:week 26
change from baseline, improvement
Laboratory examination
Time frame:week 26
change from baseline, improvement
Baseline in 12-ECG values
Time frame:week 26
change from baseline, improvement
Aβ positron emission tomography (PET)
Time frame:week 26
change from baseline, improvement
Concentrations of SHR-1707
Time frame:week 26
concentration, descriptive
Anti-Drug antibody
Time frame:week 26
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.