Alzheimer's DiseasePhase 2NCT06199037
Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients
A Phase 2 study testing SHR-1707 in people with Alzheimer's Disease, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of SHR-1707 In Patients with Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- SHR-1707
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2024to 30 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥50 and ≤85 on the date of signing the informed consent, males or females;
- BMI≥18kg/m2 and ≤32 kg/m2, weight ≥45 kg且≤100 kg at screening or baseline；
- must meet the diagnostic criteria for MCI due to AD or mild AD;
- The total score of HAMD-17 should be ≤10 scores at screening;
- The score of Hachinski ischemic scale should be ≤4 scores at screening;
- amyloid PET scan results from the central laboratory confirmed the presence of pathological changes in AD;
- Agreed to test ApoE genotype;
- Have a stable caregiver; where symptomatic drugs for AD is used, they must be stable for at least 1 months prior to the screening visit;
Who cannot join
- Cognitive impairment of subjects due to other medical or neurological factors (other than AD);
- History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year;
- Any psychiatric diagnosis that may interfere with the subject's cognitive assessment;
- Cannot tolerate MRI or has contraindications to MRI, has significant lesions shown on MRI during screening, or has other conditions that the investigator believes may bring a significant risk to the subject;
- Patients who had severe trauma or had undergone surgery within 6 months prior to screening, or were scheduled to undergo surgery during the trial;
- History of moderate (3b) or severe renal failure or insufficiency;
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- Uncontrolled hypertension: systolic blood pressure > 160mmHg and diastolic blood pressure >100mmHg during screening or baseline;
- 12-lead ECG showed QTcF >450ms for male and >470ms for female during screening;
- History of hypoglycemic coma or uncontrolled diabetes 6 months prior to the screening period;
- Thyroid dysfunction；
- Had unstable or clinically significant cardiovascular disease within 1 year prior to the screening period, had or currently has atrial fibrillation;
- History of malignancy within 5 years prior to screening;
- Patients with clinically significant systemic immunosuppression due to the persistent effects of immunosuppressive drugs;
- Human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody and hepatitis C virus antibody (HCV-Ab) were positive during screening.Hepatitis B active subjects [Hepatitis B virus surface antigen (HBsAg) positive with HBV DNA > upper limit of normal]
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times ULN, or total bilirubin exceeding 2 times ULN
- Folic acid or vitamin B12 below the lower limit of normal
- coagulation disorders
- According to the investigators, the subjects were suicidal or had committed suicidal behaviour in the six months before the screening period;
- Severe visual or hearing impairment, unable to cooperate with the completion of the scale;
- A woman who is pregnant, or a woman of childbearing potential whose pregnancy test results are positive, or who is breastfeeding; or has a plan to have a child, unwilling or unable to take effective contraceptive measures within 30 days prior to the screening period or six months after the last use of the investigational drug.
- History of drug abuse or addiction;
- Three months prior to the randomization period or planned to use dual antiplatelet or anticoagulant drugs during the trial;
- Received any passive immunotherapy or other long-acting biologics used to prevent or delay cognitive decline within 3 months prior to screening;
- Investigators and relevant staff of the research Centre or others directly involved in programme implementation;
- The investigator considers that there are any circumstances that would cause the subject to be unable to complete the study or pose a significant risk to the subject or other factors that would interfere with the subject's ability to complete the study evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of SHR-1707 In Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of SHR-1707 In Patients with Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease.
- Conditions
- Alzheimer's Disease
- Being tested
- SHR-1707, SHR-1707 placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1707Drug
1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 injection
SHR-1707 placeboDrug
1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 placebo injection
| Study group | Role | What they receive |
|---|---|---|
| SHR-1707 | Experimental | Not described Receives: Drug: SHR-1707 |
| SHR-1707 placebo | Placebo comparator | Not described Receives: Drug: SHR-1707 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in intracerebral Aβ deposition at Week 26 as assessed by brain Aβ PET
Measured: Week 26
Secondary outcomes (13)
To assess the number of patients with adverse events (AEs)
Measured: week 26
To assess the number of patients with clinically significant change from baseline in vital signs values
Measured: week 26
To assess the number of patients with clinically significant change in physical examination
Measured: week 26
To assess the number of patients with clinically significant change from baseline in laboratory examination
Measured: week 26
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Measured: week 26
To assess the number of patients with clinically significant change in brain MRI
Measured: week 26
To assess the ADA
Measured: week 26
To assess the number of patients with adverse events (AEs)
Measured: week 52\week 78
To assess the number of patients with clinically significant change from baseline in vital signs values
Measured: week 52\week 78
To assess the number of patients with clinically significant change in physical examination
Measured: week 52\week 78
To assess the number of patients with clinically significant change from baseline in laboratory examination
Measured: week 52\week 78
To assess the number of patients with clinically significant change from baseline in 12-ECG values,
Measured: week 52\week 78
To assess the number of patients with clinically significant change in Head brain MRI
Measured: week 52\week 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start5 Feb 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Why it stopped: Based on the adjustment of the sponsor's R\&D strategy, it is decided to terminate this study in advance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-1707 compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199037
- Sponsor's protocol ID
- SHR-1707-201
- Status last verified
- May 2026
- First submitted
- 27 Dec 2023
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of SHR-1707 In Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06199037
- Acronym / sponsor ID
- SHR-1707-201
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the adjustment of the sponsor's R\&D strategy, it is decided to terminate this study in advance.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the Safety, Tolerability and Pharmacodynamics of Intravenous Administration of SHR-1707 In Patients with Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SHR-1707 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| SHR-1707 | Experimental | Drug: SHR-1707 |
| SHR-1707 placebo | Placebo comparator | Drug: SHR-1707 placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥50 and ≤85 on the date of signing the informed consent, males or females;
- BMI≥18kg/m2 and ≤32 kg/m2, weight ≥45 kg且≤100 kg at screening or baseline；
- must meet the diagnostic criteria for MCI due to AD or mild AD;
- The total score of HAMD-17 should be ≤10 scores at screening;
- The score of Hachinski ischemic scale should be ≤4 scores at screening;
Key exclusion criteria (25 listed)
- Cognitive impairment of subjects due to other medical or neurological factors (other than AD);
- History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year;
- Any psychiatric diagnosis that may interfere with the subject's cognitive assessment;
- Cannot tolerate MRI or has contraindications to MRI, has significant lesions shown on MRI during screening, or has other conditions that the investigator believes may bring a significant risk to the subject;
- Patients who had severe trauma or had undergone surgery within 6 months prior to screening, or were scheduled to undergo surgery during the trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-17071 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 injection | Drug | SHR-1707 |
| SHR-1707 placebo1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 placebo injection | Drug | SHR-1707 placebo |
Primary outcome
Change from baseline in intracerebral Aβ deposition at Week 26 as assessed by brain Aβ PET
Time frame: Week 26
13 secondary outcomes
To assess the number of patients with adverse events (AEs)
Time frame: week 26
To assess the number of patients with clinically significant change from baseline in vital signs values
Time frame: week 26
To assess the number of patients with clinically significant change in physical examination
Time frame: week 26
To assess the number of patients with clinically significant change from baseline in laboratory examination
Time frame: week 26
To assess the number of patients with clinically significant change from baseline in 12-ECG values
Time frame: week 26
To assess the number of patients with clinically significant change in brain MRI
Time frame: week 26
To assess the ADA
Time frame: week 26
To assess the number of patients with adverse events (AEs)
Time frame: week 52\week 78
To assess the number of patients with clinically significant change from baseline in vital signs values
Time frame: week 52\week 78
To assess the number of patients with clinically significant change in physical examination
Time frame: week 52\week 78
To assess the number of patients with clinically significant change from baseline in laboratory examination
Time frame: week 52\week 78
To assess the number of patients with clinically significant change from baseline in 12-ECG values,
Time frame: week 52\week 78
To assess the number of patients with clinically significant change in Head brain MRI
Time frame: week 52\week 78
Results and safety
The study was stopped early (reason given: Based on the adjustment of the sponsor's R\&D strategy, it is decided to terminate this study in advance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1707 in people with Alzheimer's Disease, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on the adjustment of the sponsor's R\&D strategy, it is decided to terminate this study in advance.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in intracerebral Aβ deposition at Week 26 as assessed by brain Aβ PET (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.