Adams 2022 supplemental table tail, NCT06219629 LEARNS observational basket study, TAK071-2002 crossover trial, TAK994-2001 PK/safety phase 2 trial, TAK-341 IMED1341 MAD Apple Watch feasibility, NEA-FAST scope, Verily watch (google) JMO observational study, mObILiZe-D consortium / Bre-One uLIZE-D Apple Watch+McRoberts+Dynaport feasibility opener

study	scope
(Adams, 2022 #2373) Supplemental tail (Quantitative subscores)	10 APDM features, and 23 SW features showed progression over 12 months in early PD patients, off with smaller effect sizes compared to MDS-UPDRS. In contrast, composite digital measures, constructed from (1) 16 APDM features, (2) 12 SW features, and (3) 16 APDM SW features, all showed digital measures with larger effect sizes that MDS-UPDRS. Among these, the APDM-based composite digital measures performed the best with effect size = 0.79 (vs MDS-UPDRS effect size = 0.31). (Mammen, 2023 #2691)
NCT06219629 [LEARNS]	Konekta's neuroscience toolkit, to capture both clinician ratings and patient-reported experiences by harnessing the power of mobile technologies and advanced technologies; to objectively measure sleep disturbances in real-world settings. 4-Tee Park, Observational, Basket Study to Determine Usability, Validity and Biomarker Discovery for Mobile EEG, Wearable and Device Collected Objective Measurement of Disturbed Sleep and Neurologic Disorders [LEARNS]. Both the basket and disease progression components of the study are designed to collect data across multiple time points.
TAK071-2002 (US single sentry)	Ariel Dowling Start: May 2020; End: Dec 2021	In office and at home subjects with PD patients with mild-moderate cognitive impairment / various wearable monitoring devices for clinical study Treatment crossover study to evaluate, oral, double-blinded, controlled, placebo controlled, treatment crossover study n = 64
TAK994-2001	Ariel Dowling	Pivotal trial Wearable telegraphy devices (FitBit?) iPad and other wearables. Ariel Dowling and ongoing study, hold the 2-week phase 2 trial to evaluate TAK-994 in PD patients with EDS - phase 2a, randomized, double-blind, placebo-controlled, parallel, 2-treatment study goal: to assess the efficacy, safety, tolerability and PK of multiple oral doses of TAK-994 administered to subjects with PD who have EDS
TAK-341 (IMED1341) MAD	Modified version of Watch PD, using Apple Watch and iPhone	Feasibility assessment of Apple Watch to detect autonomic dysfunction in PD patients Goal: - Demonstrate that we can reliably collect continuous HR and from 5 valuable RR intervals and heart rate variability (HRV) using a wrist-worn wearable (Apple Watch). - Demonstrate that measurements of HRV obtained from an Apple Watch during in-clinic daytime maneuvers and at-home sleep are reliably distinguish persons with PD from non-RBD controls by showing a significantly reduced mean RR interval (RRI) variability. - Demonstrate that patients with Parkinson's Disease (PD) can reliably wear an Apple Watch and perform simple assessments with it in-clinic and at-home - Stratification market(prediction) ascertainable - Select, re-purpose, or develop digital technology that could be used to identify individuals with high likelihood of developing Parkinson's Disease within 2-3 years (prodromal PD patients) - Develop a workflow that would facilitate the screening of up to 300+ individuals to identify ~50 candidates that are clinically valuable to enroll in a prodromal PD natural history study within reasonable budget - Digital technologies under consideration include: - Online / web-based questionnaires - WatchPAT: home sleep testing, currently used by OSA, that may be helpful in identifying patients with RBD - All home assessment - In-clinic gait analysis (maybe APDM system from TAK-071-2002)
NEA-FAST	Start: Aug 2019 End: Sept 2023	TBD No cash: Watch PD data: TAU-3 / 0.5, 0.25 Stat -0.2, ClinOps -0.1, REG -0.1 FTE Scope: To propose context-dependent digital solutions that can reliably measure clinically relevant functional impairments in patients and to validate them for the use in clinical trials, in line with the regulatory requirements: - Disease areas focus. - Neurodegenerative Movement Disorders (NMD) - PD & HD - Immune Mediated Inflammatory Diseases (IMID): RA, SLE, IBD - Objectives: - The identification and selection of valuable disabilities in the activities of daily living (ADL) that can be optimally 'digitalized' with the currently available portable technology, some of those being common in partially shared among the NDD and IMID. The validation will involve the development of analytic outcome measures, and behavioural sensors that capture symptoms of valid measure clinical and behavioural signs & symptoms relating back to one used in clinical trials to measure efficacy or tolerability. Other Daily Living Activities, like:
J401 / IM01 Verily watch (google)	JMO is running observational clinical study in collaboration with Verily https://verily.com/ i) In that study, Takeda is responsible for the clinical enrollment control. ii) The enrolment period will be continuing until next year, but the rate is very slow so the team will miss the targeted enrolment numbers (around 150). iii) During the observational period, patients are needed to be involved in two treatment, mostly with Levodopa; to wear the Verily watch, and to conduct some movement choice twice a day. (this makes the compliance difficult). iv) In addition to the at-home study assessments, all patients are required to be brought in for a week to turn some additional evaluation (this also makes the enrolment difficult) v) There are no intention to include in this study the enrolled patients vi) Data collection will be finished by summer next year, then Verily (google) will analyze the data, this takes about a year. So the analyzed data will be available around summer 2022. Not an early patients (Dx > 5y) Admission: 0 3 parts 1 in (admission) 1 m (Hospital) 1 m (home) Not an early PD: Clinical trial 자료 가만 Cross sectional effect size 가 0.5? - 명령기. DatScan correlation: X 20210113 Ariel Dowling we are aware of the study and are in contact with the JMO team about the study, we are aware of the results, and we are monitoring the subset for the study. Other than that, we don't have additional plans to integrate Verily into a study anytime soon, but they are on our radar as a potential partner for PD studies. Apple Watch, this will be much quieter, but available data is similar. Horizon 2020 matching fund to EFPIA, started March 2019 - and 2024. 800 PD patients will be studied. Algorithm validation delivery 1Q2021 / Clinical validation deliver 2Q2024 / EMA/FDA regulatory delivery 4Q2024 clinical & regulatory validation of Walking Test in hospital and in real world Aim: Connect digital mobility assessment to clinical trials in regulatory and clinical endorsement Overarching objectives of MOBILISE-D are four-fold - Deliver valid sensor-algorithm solution for real-world digital mobility assessment - Validation: Provide evidence that digital outcomes accurately measure, monitor disability, and predict clinical outcomes in patients with COPD, MS, PD, and PFF - Obtain key regulatory and health stakeholder approval for digital mobility assessment in clinical trials and healthcare delivery - Make underlying algorithms for digital mobility assessment publicly available for use Transforming the Objective Real-world measurement of Symptoms (TORUS), University of Bristol and the Volocity Centre for Activity and Movement Studies (VICAM), led by Professor Ian Craddock from Bristol and Lynn Rochester (newcastle), TORUS will pull together a strong multidisciplinary academic and computer vision techniques (but the methodology could be applied to a wide variety of patients with movement disorders).
One uLIZE-D Consortium (Bre-One)	Kameda / Nakatome - No cash TAU -0.3, ESI -0.25, Stat -0.25, REG -0.1, GMA/EU -0.1 FTE Start: Feb 2019 End: Dec 2023	Apple Watch McRoberts gait sensor Dynaport MoveMonitor+ GAIT-P (?) Roche tool from "Available" to "in Development" as we are currently in development with them on how this can be... Takeda trial In addition to the WATCH-PD platform (which is implemented by Digital Artefacts), there are other commercially available devices such as the Global Kinetics PKG system (https://pkgcare.com/), the Verily study watch PD platform (currently used in a Takeda clinical trial in...