MedPath

BN29553

Phase 3
Completed
Conditions
Alzheimer's disease(AD)
Registration Number
JPRN-jRCT2080223539
Lead Sponsor
CHUGAI PHARMACEUTICAL CO.,LTD.
Brief Summary

Crenezumab did not demonstrate evidence of clinically meaningful effects the primary endpoint and secondary endpoints. Crenezumab was safety and well-tolerated in patients with prodromal to mild AD. The steady-state mean trough concentrations of crenezumab were maintained throughout the treatment period.

Detailed Description

Not available

Recruitment & Eligibility

Status
completed
Sex
All
Target Recruitment
806
Inclusion Criteria

Meet NIA-AA core clinical criteria for probable AD dementia or prodromal AD
-Having mild symptomatology, as defined by a screening MMSE score of 22 points and higher, and CDR-GS of 0.5 or 1.0

etc.

Exclusion Criteria

-Any evidence of a condition other than AD that may affect cognition
-Meet the exclusion criteria of MRI at screening

etc.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
safety<br>efficacy<br>Observation/Examination
Secondary Outcome Measures
NameTimeMethod
pharmacokinetics<br>pharmacodynamics<br>Examination
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