Pathology tail (basal forebrain / hippocampal cholinergic system / Frontal cortex / ChAT activity), Hellinger 2008 review postmortem note, Consortium (MOBILIZE-PD / Verily / Takeda Japan / Watch / IDEA-NeXT / AMP-PD), PPMI (Enrollment / LP / Genetics Consensus / Visit / DaTscan completeness), Operations Manuals & Specimen Processing Maps, Other PPMI Program Protocols, Data & Biospecimen Use Agreements
| PDD | PDND (PD without dementia) | ||
|---|---|---|---|
| Basal forebrain | ↓ | ↓ | |
| hippocampal cholinergic system | ↓ | ↓ | |
| Frontal cortex | ↓ ChAT activity, Hippot type | ||
| (Hellinger, 2008 #2872) | Review postmortem |
limbic and cortically projecting dopaminergic neurons in the mesencephalic limbic system [173]
there has been relatively little rigorous study of neuronal death in clinical PD, ie there is no autopsy study in the cortex in PD
| (Stoffers, 2010 #2873) | Structural MRI | 123 newly diagnosed patients with PD (P-CG PD-MCI: V/B), and 58 healthy controls |
|---|---|---|
| (Pereira et al. 2014, PMID) | The comparison between PD without MCI vs PD-MCI groups showed regional thinning in the left precuneus (P [도 1번도]) [1번] in patients with PD-MCI [Figure 1, Table 2]. | |
| (Agosta et al. 2013, PMID) | (PD vs HC) Human, MRI: A very little Gray matter atrophy even at advanced stages (Agosta et al. 2013, PMID), the only region showing additional atrophy in moderate vs mild PD cases was the thalamus. |
Consortium
| Aim | commitment | |
|---|---|---|
| MOBILIZE-PD (Boehringer Ingelheim) | Horizon 2020 matching fund to EFPIA: started March 2019 / and 2024. 800 PD patients with be studied. Algorithm validation delivery 1Q2021 / Clinical validation deliver 2Q2024. EMA/FDA regulatory delivery 4Q2024. clinical validation of Walking Test in hospital and a real world setting (MOBILIZE-DM use AKINEKO 가 만들고) | minimum 0.2 FTEs/year as in-kind contribution (i.e. scientist time) |
| Verily Takeda Japan Watch Pilot study | funds from Takeda Japan: Started July 2019 / profiling PD motor signs & symptoms before, during and after L-DOPA, adjustment in Japanese patients. | Commitment and funding agreed: some data management and analysis support required |
| IDEA-NeXT NIH (via NeuTRX-EU) | Horizon 2020 matching fund to EFPIA: starts November 2019 (PILOT validation 1Q2021 / Clinical validation 2Q2022). 500 PD patients and 500 HD patients will be studied. Conditional and structural validation deliveries. Clinical & initial regulatory validation of Activities of Daily Living, sleep & fatigue as a market endpoint for their use in clinical trials | minimum 0.5 FTEs/year as in-kind contribution (i.e. scientist time) / minimum of 2-5M equivalent of digital clinical data from the WATCH-PD study and from GSH Therapeutics (BD), to be shared before 1Q2024. |
| AMP-PD |
For: PPMI - PDBP - HBP - BioFind - Earn Equity > LBD DWAS Accelerating Medicines Partnership in Parkinson's Disease 9-account (membership): application for renewal submitted Feb. 20200122 |
Dashboard: https://amp-pd.org/data/summary-data-dashboard https://amp-pd.org/study-design/study-cohorts#prod-pmail |
PPMI (Parkinson’s Progressive Markers Initiative)
Adam is the primary representative, and Steve is secondary
- Study site
- Download raw data and Data Cuts
- Request biospecimens
- Explore Biospecimen Inventory
- Inclusion and Exclusion Criteria
Prodromal: https://www.ppmi-info.org/study-design/study-cohorts#prod-pmail/
MJFF (?) initiated recruitment of 250 GBA1 (125 affected and 125 unaffected); 201903. (2019 PPMI ANNUAL INVESTIGATORS MEETING May 1-2). day1 slides
- ENROLLMENT - 2018
- LUMBAR PUNCTURE COMPLETENESS
- PPMI Genetics Consensus: Results
- VISIT COMPLIANCE - 2019
- DATSCAN COMPLETENESS
Study Documentation
https://www.ppmi-info.org/study-design/research-documents-and-sops/
| Primary content | Notes | Archived prior version | |
|---|---|---|---|
| Clinical protocol current | Archive | ||
| Schedule of activities (SOAs) | Archive | ||
| Case report forms (CRFs) | Archive |
Operations Manuals and Specimen Processing Maps
| Category | Primary content | Notes | Archived prior version | |
|---|---|---|---|---|
| General | Operations Manual | Prior version | ||
| Biologics | Biologics Manual | Details of acquisition procedures for blood, CSF, urine, and the skin biopsies | Prior version | |
| Pathology Manual | Details of acquisition, collection, analyses, and storage managed by PPMI Pathology Core | Prior version | ||
| Genetics | Genetics Manual | Prior version | ||
| Specimens | Cell Lines Manual of Procedures | Details of genetic processing | ||
| Biospecimen Processing Map Manual | ||||
| Imaging (Molecular and Structural) | MRI | Current MRI Acquisition protocol. | Prior version - August 2020 | Prior version - Jan 2015 |
| DTI | Current DTI Acquisition protocol. | |||
| SPECT | Dopamine transporter SPECT protocol. Independent Review Charter can be found here. | Archive |
Other PPMI Program Protocols
| Primary content | Notes | ||
|---|---|---|---|
| PPMI Online Protocol | PPMI Online is a longitudinal study of patient reported outcomes (PROs) administered online, including people with and without PD. This document provides an overview of the PPMI Online study. | ||
| PPMI Online Schedule of Activities | The frequency of study visits and what assessments occur at each visit for PPMI Online. | ||
Data and Biospecimen Use Agreements and Policies
Uncertain Spans
| location | transcription | uncertainty |
|---|---|---|
| Stoffers 2010 row | 123 newly diagnosed patients with PD (P-CG PD-MCI: V/B) | partly clipped; preserved verbatim. |
| Pereira 2014 row | (P [도 1번도]) [1번] | mixed Korean/English narrative with OCR artefacts; preserved verbatim. |