Table 1.
Prespecified primary and exploratory subpopulations
| Subpopulation | Category | Disease progression | ≥20% of patients |
|---|---|---|---|
| Primary subpopulations | |||
| MAO-B inhibitor at baseline | Yes | Faster | Yes |
| No | Slower | Yes | |
| Hoehn and Yahr stage | 2 | Faster | Yes |
| 1 | Slower | Yes | |
| RBDSQ | ≥5 | Faster | Yes |
| <5 | Slower | Yes | |
| Data-driven subphenotypes | Diffuse malignant | Faster | Yes |
| Nondiffuse malignant | Slower | Yes | |
| α-synuclein skin (staining by IHC on skin biopsy sections at baseline)a | Yes | Faster | No |
| No | Slower | No | |
| DaT-SPECT SBR (ipsilateral putamen)b | Very abnormal | Faster | No |
| Abnormal | Slower | No | |
| Exploratory subpopulations | |||
| Age at baseline | ≥60 years | Faster | Yes |
| <60 years | Slower | Yes | |
| Sex | Male | Faster | Yes |
| Female | Slower | Yes | |
| Disease duration | >12 months | Faster | Yes |
| <12 months | Slower | Yes | |
| Age at diagnosis | ≥60 years | Faster | Yes |
| <60 years | Slower | Yes | |
| Atrophy in the nucleus basalis of Meynert | Yes | Faster | No |
| No | Slower | No | |
| MoCA total score | <22 | Faster | No |
| >22 | Slower | No | |
| GBA mutationc | Yes | Faster | Nob |
| No | Slower | Nob | |
| Motor subphenotypes I | Akinetic–rigid | Faster | Yes |
| Tremor-dominant | Slower | Yes | |
| Motor subphenotypes II | PIGD | Faster | Yes |
| Tremor-dominant | Slower | Yes | |
aNote that these data may be confounded by technical pre-processing issues.
bDefined on the baseline data with a validated cutoff of 0.6.
cFor the glucocerebrosidase (GBA) mutation subgroup, a 15% sample cutoff was prespecified because very few participants were expected to carry the mutation.
DaT-SPECT, dopamine transporter-single-photon emission computed tomography; IHC, immunohistochemistry; MAO-B, monoamine oxidase-B; MoCA, Montreal Cognitive Assessment; PIGD, postural instability gait dysfunction; RBDSQ, Rapid Eye Movement Sleep Behavior Disorder Screening Questionnaire; SBR, striatal binding ratio.