Synapl.
PMDA

Pharmaceuticals and Medical Devices Agency

Japanese regulatory authority for pharmaceuticals and medical devices. Reviews clinical outcome assessment use in registration trials.

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Accepted as endpoint(2)

EDSSNeurology
Expanded Disability Status Scale

Standard MS disability staging scale.

Disability endpoint in Japanese MS trials

PMDA MS review reports
ADAS-CogDementia & Cognition
Alzheimer's Disease Assessment Scale - Cognitive

AD trials cognitive endpoint (11- and 13-item forms).

Cognitive endpoint in Japanese AD registration trials

PMDA AD review reports

Referenced in guidance(1)

MDS-UPDRSNeurology
MDS-Unified Parkinson's Disease Rating Scale

MDS-revised Parkinson's rating scale.

Used in Japanese PD registration trials

PMDA review reports for PD therapies