Phase I Study of RO7105705 in HV/AD patients

Phase 1

Completed

• Conditions: Alzheimer's disease

• Registration Number: JPRN-jRCT2080224616
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

This study showed the safety of a single dose of 2100 to 16800 mg of RO7105705 in Japanese healthy adult males and multiple doses of 8100 mg in Japanese patients with mild-to-moderate AD. The pharmacokinetic linearity of this drug was confirmed in a single dose from 2100 to 16800 mg. ADA was not detected in all subjects.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-27
• Study Completion: 2020-12-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

< Male HV and Patients with AD >
- Body weight between 40 kg and 100 kg, inclusive, at screening
< Male HV only >
- Aged between 20 and 60 years, inclusive
< Patients with AD only >
- Aged between 50 and 80 years, inclusive
- Diagnosis of probable AD dementia based on National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria
- Screening MMSE score of 16 to 28 points
- Evidence of AD pathology as indicated by brain amyloid accumulation determined by quantitative determination of Abeta 42 concentration in CSF

Exclusion Criteria

< Male HV and Patients with AD >
- Prior treatment with any other anti-tau antibody
- History or presence of a neurologic disease other than AD that may affect cognitive function
< Patients with AD only >
- Abnormal findings on brain MRI at screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified