(Shen, 2020 #1800)α-syn PFF based mouse modelwe injected preformed α-syn fibrils into the sublaterodorsal tegmental nucleus and performed regular polysomnographic recordings and parkinsonian behavioural and histopathological studies in these mice. As a result, we recapitulated RBD-like behaviours in the mice and further showed that the α-synopathy and neuron degeneration identified within the sublaterodorsal tegmental nucleus acted as the neuropathological substrates.

GBA → RBD

  • Penetrance (GBA → RBD)
    • No report?
  • Odds Ratio (GBA in RBD)
    • (Gan-Or et al. 2015, PMID 26401515) idiopathic RBD patients (n = 265) and our in-house controls (n = 189). (OR) of 2.63 (95% CI 1.30–5.29, P = 0.0052) for all variants, and OR of 3.46 (95% CI 1.40–8.56, P = 0.0045) for the pathogenic variants. We further compared the frequency of GBA mutations in the RBD cohort to a pooled population from all studies that performed full sequencing of the GBA gene in European controls (Table S1). In this pooled control group, 40/2240 (1.8%) individuals were carriers of GBA mutations, resulting in an OR of 6.24 (95% CI 3.76–10.35, P < 0.0001).
    • 20210830 Gan-Or: With RBD, 10-12% of population have GBA mutations
    • 10.2% of European RBD patients had a known pathogenic GBA mutation, corresponding to an OR=6.2. When the PD risk variants p.E326K and T369M are included, the proportion of GBA pathogenic variants in RBD rises to 14% [3].
    • among patients with idiopathic RBDs there is an increased frequency of GBA mutations (2.6–11.6% of RBD patients vs. 0.4–1.8% of the controls) [65,91,93].
    • the odds ratio (OR) for RBD was 6.24 (95% CI 3.76–10.35, P < 0.0001) [65].
    • Subjects with homozygous GBA mutations, thus affected with GD, and heterozygous carriers with no PD, presented significant worsening of rapid eye movement sleep behavior disorder scores over a period of time of two years compared with non-carrier subjects [92].
    • The presence of GBA mutations does not seem to increase the risk among RBD patients of phenoconverting into PD [93]
    • GBA may play a role in the development of RBDs, but not necessarily in determining more severe phenotypes.
  • Penetrance

GBA → RBD → PD

  • RBD seems to be more frequent in PD patients with GBA mutations compared with patients without this mutation (OR 3.13) [48,65,67,76].
  • RBDs are also more frequent in PD patients with concomitant GD than in heterozygous carriers [48].

RBD → PD

  • (Schenck et al. 2013, PMID 23347909) Up to 81% of the patients initially diagnosed with idiopathic RBD eventually developed neurodegenerative diseases in long-term follow-up studies. (majority is α-synopathy)
  • RBD has been reported to be present in 15-72% of PD patients and is associated with poor parkinsonian symptoms, higher daily levodopa dosage, poor autonomic symptoms and cognitive impairment in PD patients. 2,9-13

RBD in PD

Initial (?) Braak staging

PSYCHIATRIC OUTCOMES IN PD

VariablePD Subjects
Baseline
(N = 423)
Year 1
(N = 395)
Year 2
(N = 378)
Year 3
(N = 366)
Year 4
(N = 346)
Year 5
(N = 316)
GDS-15
N423395377366343314
<5364 (86.1%)330 (83.5%)310 (82.2%)304 (83.1%)283 (82.5%)251 (79.9%)
5 or above59 (13.9%)65 (16.5%)67 (17.8%)62 (16.9%)60 (17.5%)63 (20.1%)
STAI State
N422395378364343313
<40318 (75.4%)305 (77.2%)295 (78.0%)292 (80.2%)276 (80.5%)246 (78.6%)
40 or above104 (24.6%)90 (22.8%)83 (22.0%)72 (19.8%)67 (19.5%)67 (21.4%)
MDS-UPDRS Part I Psychosis
N423395378366343316
0410 (96.9%)376 (95.2%)350 (92.6%)327 (89.3%)300 (87.5%)276 (87.3%)
1 or above13 (3.1%)19 (4.8%)28 (7.4%)39 (10.7%)43 (12.5%)40 (12.7%)
MDS-UPDRS Part I Apathy
N423395378366343316
0-1412 (97.4%)366 (92.7%)343 (90.7%)338 (92.3%)309 (90.1%)278 (88.0%)
2 or above11 (2.6%)29 (7.3%)35 (9.3%)28 (7.7%)34 (9.9%)38 (12.0%)
MDS-UPDRS Part I Fatigue
N422395378366345316
0-1375 (88.9%)329 (83.3%)301 (79.6%)293 (80.1%)262 (75.9%)216 (68.4%)
2 or above47 (11.1%)66 (16.7%)77 (20.4%)73 (19.9%)83 (24.1%)100 (31.6%)
MDS-UPDRS Part I Insomnia
N422395378366345316
0-1323 (76.5%)272 (68.9%)253 (66.9%)236 (64.5%)198 (57.4%)175 (55.4%)
2 or above99 (23.5%)123 (31.1%)125 (33.1%)130 (35.5%)147 (42.6%)141 (44.6%)
Epworth Sleepiness Scale
N423395377364343313
<10357 (84.4%)329 (83.3%)292 (77.5%)264 (72.5%)246 (71.7%)216 (69.0%)
10 or above66 (15.6%)66 (16.7%)85 (22.5%)100 (27.5%)97 (28.3%)97 (31.0%)
RBDSQ
N420393378365342312
<6311 (74.0%)288 (73.3%)253 (66.9%)239 (65.5%)216 (63.2%)193 (61.9%)
6 or above109 (26.0%)105 (26.7%)125 (33.1%)126 (34.5%)126 (36.8%)119 (38.1%)
QUIP
N422395378366343313
No disorders335 (79.4%)341 (86.3%)301 (79.6%)280 (76.5%)251 (73.2%)228 (72.8%)
Any 1 or more disorders*87 (20.6%)54 (13.7%)77 (20.4%)86 (23.5%)92 (26.8%)85 (27.2%)
(Hu, 2015 #1794)Patients with PRBD have higher frequency of rigidity-bradykinesia type of PD,
PRBD group has longer disease duration, more advanced disease stage, severer motor symptoms, higher incidence of rigidity-bradykinesia type of PD and more non-motor symptoms.

RBD → Dementia

  • 20210830 Gan-Or: Those with RBD develop dementia as well as PD very quickly. If you look at them 5 years into their neurodegenerative disease, they quickly develop both dementia/MCI and Parkinson’s. Some happen to develop the motor symptoms first, or the cognitive symptoms first, but they pretty quickly have both motor and cognitive symptoms

RBD → MSA

20210830 Gan-Or: 5% convert from RBD to MSA

RBD → PDD/DLB

20210830 Gan-Or: 50% convert from RBD to PDD/DLB

Unmet Needs across Parkinson’s Patient Populations

Increasing Neuronal Degeneration →
At RiskProdromalEarly / MildIntermediate / ModerateAdvanced / Severe
Disease Modification (green tile, spans Prodromal → Advanced/Severe)
  • Ability to slow, arrest or reverse disease progression
Treatment of Non-Motor Symptoms (Psychosis, Dementia) (pink tile, spans Intermediate/Moderate → Advanced/Severe)
  • Ability to prevent and / or reduce severity of non-motor symptoms as disease progresses
Treatment of Motor Response Complications: PD-LID* and Wearing OFF** (grey tile, spans Intermediate/Moderate → Advanced/Severe)
  • Ability to administer levodopa continuously, thereby precluding development of motor response complications such as PD-LID and wearing OFF
  • Ability to prevent or reduce time and / or intensity of periods of LID, with fewer side effects than current SOC†
  • Ability to prevent or quickly alleviate decreased mobility due to wearing OFF

Legend: Motor & Non-Motor Function · Non-Motor Function · Motor Function · Complications

Increasing Therapeutic Importance ↑

Note: * LID = Levodopa Induced Dyskinesia. ** Wearing OFF = shortened time of periods of benefit between levodopa doses. † Current SOC for PD-LID is amantadine, which causes hallucinations.

22 — Takeda Pharmaceuticals International — Confidential, for internal use. Proprietary business information

GBA pathway in RBD

brainCSFSERUM
Huebecker et al. 2019, PMID 30703585

Uncertain Spans

  • “(Shen, 2020 #1800)” — top row’s reference cell; the year/citation key is partially clipped above the visible top of the page; transcribed from the OCR evidence as “(Shen, 2020 #1800)“.
  • RBDSQ “<6” Year 2 row — value “253 (66.9%)” sits one row above its label cell in the source layout due to the row-strip break; transcribed against the row label as the source intends.
  • GBA pathway “brain” / “CSF” / “SERUM” columns — body of the table is empty in the visible portion (figure panels occupy the cells); the cells are left blank and the figure is preserved as evidence rather than embedded.
  • “Increasing Therapeutic Importance” — the slide’s vertical-axis arrow label is visible on the left edge of the slide image; transcribed verbatim from the source.