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

Korábbi kezelés

• Exclusion criteria related to previous or concomitant diseases, as listed in the protocol.
• The subject is suicidal according to the investigator's judgment or has committed suicidal behaviour within 6 months prior to the screening period.
• 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.
• Those who have participated in a clinical trial of any drug or medical device within 3 months prior to screening.

Más betegség

• Cognitive impairment due to other medical or neurological factors (non-AD).
• History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year.
• Any psychiatric diagnosis that may interfere with the subject's cognitive assessment.
• Severe visual or hearing impairment, unable to cooperate in the scale examination.
• Patients suspected to be allergic to Aβ antibody drugs and their excipients.

Laborértékek

• Exclusion criteria related to general or laboratory tests, as listed in the protocol.

Életkor

• Women who are pregnant, or women of childbearing age with positive pregnancy test results or are lactating.

Egyéb

• Inability to tolerate MRI examination or have contraindications to MRI examination.
• Investigators and site-related personnel or other persons directly involved in the implementation of the protocol.
• Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.

• Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
• Male or female aged between 55 years and 85 years (inclusive) at the date of signed consent form.
• Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~32 kg/m2 (inclusive)at screening or baseline.
• The subjects must meet the following clinical criteria for Mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or criteria for mild AD.
• The subjects should have a stable caregiver who will help the patients to participate in the whole study process.