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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

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:
Alzheimer's Disease (AD) 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events(AEs)
Timepoint [1] 0 0
week 26
Primary outcome [2] 0 0
Baseline in vital signs value
Timepoint [2] 0 0
week 26
Primary outcome [3] 0 0
Physical examination
Timepoint [3] 0 0
week 26
Primary outcome [4] 0 0
Laboratory examination
Timepoint [4] 0 0
week 26
Primary outcome [5] 0 0
Baseline in 12-ECG values
Timepoint [5] 0 0
week 26
Primary outcome [6] 0 0
MRI
Timepoint [6] 0 0
week 26
Secondary outcome [1] 0 0
Aß positron emission tomography (PET)
Timepoint [1] 0 0
week 26
Secondary outcome [2] 0 0
Concentrations of SHR-1707
Timepoint [2] 0 0
week 26
Secondary outcome [3] 0 0
Anti-Drug antibody
Timepoint [3] 0 0
week 26

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
Active, not 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)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [2] 0 0
Southern Neurology - Sydney
Recruitment hospital [3] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06114745