Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06114745




Registration number
NCT06114745
Ethics application status
Date submitted
11/10/2023
Date registered
2/11/2023
Date last updated
21/08/2024

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
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
Secondary ID [1] 0 0
SHR-1707-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Dysfunction 0 0
Alzheimer's Disease (AD) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Navepegritide - Once weekly double-blinded treatment with SC injection of 100 µg/kg of Navepegritide for 52 weeks
Comparator / control treatment
Control group

Outcomes

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.
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/11/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06114745
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathy You
Address 0 0
Country 0 0
Phone 0 0
+61 02 9299 0433
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06114745