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CompletedPhase 1

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

Atridia Pty Ltd.

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 diseaseStudy partner/caregiver requiredMRI contraindications excluded

Primary endpoints

Adverse events(AEs)Baseline in vital signs valuePhysical 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

NCT IDNCT06114745
Org study IDSHR-1707-103

Timeline

Milestones

Study first posted2023-11-02actual
Study start2024-04-17actual
Primary completion2025-07-08actual
Study completion2025-07-08actual
Last update posted2025-07-11actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
6
Safety / tolerability / PK
2
Neuroimaging
1

Neuroimaging

1 endpoint
Primary/protocol endpoint

MRI

Time frame:week 26

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Adverse events(AEs)

Time frame:week 26

event count, event

Primary/protocol endpoint

Baseline in vital signs value

Time frame:week 26

change from baseline, event

Other (unclassified)

6 endpoints
Primary/protocol endpoint/low confidence

Physical examination

Time frame:week 26

change from baseline, improvement

Primary/protocol endpoint/low confidence

Laboratory examination

Time frame:week 26

change from baseline, improvement

Primary/protocol endpoint/low confidence

Baseline in 12-ECG values

Time frame:week 26

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Aβ positron emission tomography (PET)

Time frame:week 26

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Concentrations of SHR-1707

Time frame:week 26

concentration, descriptive

Secondary/protocol endpoint/low confidence

Anti-Drug antibody

Time frame:week 26

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.