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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06114745
Registration number
NCT06114745
Ethics application status
Date submitted
11/10/2023
Date registered
2/11/2023
Date last updated
22/05/2024
Titles & IDs
Public title
A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
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Scientific 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
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Secondary ID [1]
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SHR-1707-103
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease (AD)
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SHR-1707 injection
Treatment: Drugs - Placebo
Experimental: Dose level 1 SHR-1707 - SHR-1707 is administered intravenously.
Placebo Comparator: Dose level 1 Placebo - Placebo is administered intravenously.
Treatment: Drugs: SHR-1707 injection
Drug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion
Treatment: Drugs: Placebo
Placebo will be administered through IV infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adverse events(AEs)
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Assessment method [1]
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To assess the number of patients with adverse events
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Timepoint [1]
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week 26
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Primary outcome [2]
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Baseline in vital signs value
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Assessment method [2]
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To assess the number of patients with clinically significant change from baseline in vital signs value
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Timepoint [2]
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week 26
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Primary outcome [3]
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Physical examination
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Assessment method [3]
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To assess the number of patients with clinically significant change in physical examination
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Timepoint [3]
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week 26
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Primary outcome [4]
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Laboratory examination
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Assessment method [4]
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To assess the number of patients with clinically significant change from baseline in laboratory examination
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Timepoint [4]
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week 26
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Primary outcome [5]
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Baseline in 12-ECG values
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Assessment method [5]
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To assess the number of patients with clinically significant change from baseline in 12-ECG values
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Timepoint [5]
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week 26
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Primary outcome [6]
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MRI
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Assessment method [6]
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To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)
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Timepoint [6]
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week 26
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Secondary outcome [1]
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Aß positron emission tomography (PET)
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Assessment method [1]
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To assess the change from baseline in intracerebral Aß deposition as measured by brain Aß positron emission tomography (PET)
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Timepoint [1]
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week 26
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Secondary outcome [2]
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Concentrations of SHR-1707
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Assessment method [2]
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To assess concentrations of SHR-1707 after multiple doses of administration
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Timepoint [2]
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week 26
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Secondary outcome [3]
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Anti-Drug antibody
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Assessment method [3]
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To assess the incidence and time of occurrence of anti-SHR-1707 antibodies
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Timepoint [3]
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week 26
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Eligibility
Key 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.
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Minimum age
55
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
7/11/2025
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Actual
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Liverpool Hospital - Sydney
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Recruitment hospital [2]
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Southern Neurology - Sydney
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Recruitment hospital [3]
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Austin Health - Melbourne
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment postcode(s) [2]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Atridia Pty Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06114745
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kathy You
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Address
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Country
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Phone
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+61 02 9299 0433
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06114745
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