CompletedPhase 1

A Study of SHR-1707 With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

China33 participantsStarted 2023-02-17

Plain-language summary

This study aims to evaluate the safety, tolerability and pharmacodynamics of intravenous administration of SHR-1707 In patients with mild cognitive impairment due to Alzheimer's Disease or mild Alzheimer's Disease.

Who can participate

Age range

55 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 55 and ≤ 85 on the date of signing the informed consent, males or females;
. BMI ≥ 19 kg/m2 and ≤ 32 kg/m2, weight ≥ 45 kg and ≤ 100 kg at screening or baseline;
. Must meet the diagnostic criteria for MCI due to AD or mild AD;
. The total score of HAMD-17 should be ≤ 10 scores at screening and baseline;
. The score of Hachinski ischemic scale should be ≤ 4 scores at screening and baseline;
. Qualitative amyloid PET scan results from the central laboratory confirmed the presence of pathological changes in AD;
. Agreed to test ApoE genotype;
. Have a stable caregiver; where symptomatic drugs for AD is used, they must be stable for at least 3 months prior to the baseline visit.

Exclusion criteria

. Cognitive impairment of subjects due to other medical or neurological factors (other than AD);
. History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the number of patients with adverse events (AEs)

Timeframe: Week 26

To assess the number of patients with clinically significant change from baseline in vital signs values

Timeframe: Week 26

To assess the number of patients with clinically significant change in physical examination

Timeframe: Week 26

To assess the number of patients with clinically significant change from baseline in laboratory examination

Timeframe: Week 26

To assess the number of patients with clinically significant change from baseline in 12-ECG values

Timeframe: Week 26

To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)

Timeframe: Week 26

Trial details

NCT IDNCT05681819

SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-18

View on ClinicalTrials.gov More Alzheimer's Disease trials

Who can participate

Age range

55 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 55 and ≤ 85 on the date of signing the informed consent, males or females;
. BMI ≥ 19 kg/m2 and ≤ 32 kg/m2, weight ≥ 45 kg and ≤ 100 kg at screening or baseline;
. Must meet the diagnostic criteria for MCI due to AD or mild AD;
. The total score of HAMD-17 should be ≤ 10 scores at screening and baseline;
. The score of Hachinski ischemic scale should be ≤ 4 scores at screening and baseline;
. Qualitative amyloid PET scan results from the central laboratory confirmed the presence of pathological changes in AD;
. Agreed to test ApoE genotype;
. Have a stable caregiver; where symptomatic drugs for AD is used, they must be stable for at least 3 months prior to the baseline visit.

Exclusion criteria

. Cognitive impairment of subjects due to other medical or neurological factors (other than AD);
. History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year;

What they're measuring

To assess the number of patients with adverse events (AEs)

Timeframe: Week 26

To assess the number of patients with clinically significant change from baseline in vital signs values

Timeframe: Week 26

To assess the number of patients with clinically significant change in physical examination

Timeframe: Week 26

To assess the number of patients with clinically significant change from baseline in laboratory examination

Timeframe: Week 26

To assess the number of patients with clinically significant change from baseline in 12-ECG values

Timeframe: Week 26

To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)

Timeframe: Week 26