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A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT06114745•Atridia Pty Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

55 - 85 years

Sex

ALL

Healthy Volunteers

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.
•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.
+4 more criteria

Locations (3)

Liverpool Hospital

Sydney, New South Wales, Australia

Southern Neurology

Sydney, New South Wales, Australia

Austin Health

Melbourne, Victoria, Australia

Key Dates

Start Date

April 17, 2024

Primary Completion Date

July 8, 2025

Completion Date

July 8, 2025

Last Updated

July 11, 2025

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease (AD)

Interventions

SHR-1707 injection

DRUG

Placebo

DRUG

Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function

NCT07422857

Subjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's Disease (AD) Dementia

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UNKNOWNNA

Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study

NCT04570761

Alzheimer's Disease (AD)

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COMPLETEDPHASE4

Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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