A Phase II, Randomized, Double-blind, Placebo-controlled Study 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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• Age ≥50 and ≤85 on the date of signing the informed consent, males or females;

• BMI≥18kg/m2 and ≤32 kg/m2, weight ≥45 kg且≤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;

• The score of Hachinski ischemic scale should be ≤4 scores at screening;

• 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 1 months prior to the screening visit;

Locations
Other Locations
China
The First Affiliated hospital of USTC
RECRUITING
Hefei
Contact Information
Primary
Hongyan Qiu
hongyan.qiu@hengrui.com
18817821303
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2026-06-24
Participants
Target number of participants: 45
Treatments
Experimental: SHR-1707
Placebo_comparator: SHR-1707 placebo
Related Therapeutic Areas
Sponsors
Leads: Shanghai Hengrui Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov