Objective: The Pro-LBD cohort study is a prospective, long-term, clinic-biological cohort study of participants who are stratified by their risk of developing a Lewy body disease (LBD).

Background: Lewy body diseases include Parkinson’s disease (PD), PD dementia, and dementia with Lewy bodies. The prodromal phase of LBD is characterized by a range of non-motor symptoms, such as sleep disturbances, autonomic dysfunction, and mood changes, that can appear many years before the onset of the classical motor symptoms. Studying the prodromal phase of LBD is essential because it offers the potential for earlier diagnosis and intervention.

Method: The Pro-LBD Study is a 10-year prospective longitudinal cohort study (with the option for extension) recruiting 100 persons with assumed high or low risk for phenoconversion to LBD. Study participants are recruited based on the MDS research criteria for prodromal PD. Participants are assessed at baseline and re-examined at 2.5-year intervals using an extensive battery of clinical scales, neuroimaging (DaTSCAN and MRI), and neurophysiological (PSG and EEG) and ophthalmological examinations. Participants also provide blood, lumbar puncture, saliva, tear, urine, and faecal samples at each visit.

Results: Participants have been recruited through a 2-step screening procedure and stratified into high or low risk groups based on the MDS research criteria for prodromal PD. The response has been considerable, with nearly 500 screening interviews conducted. Here we present the study design, recruitment status, and baseline characteristics of the participants, focusing on key motor and non-motor symptoms associated with LBD. Participants will remain in the study until they progress to manifest LBD, leave the study, or the study ends.

Conclusion: ​​​​​The Pro-LBD cohort study is a promising approach to enhance our understanding of the early pathological mechanisms involved in LBD development. It can lead to the discovery of objective markers to detect prodromal disease and to predict phenoconversion in at-risk individuals. Early detection of prodromal LBD holds the potential to improve patient outcomes, reduce healthcare costs, and inform trial design for interventions at earlier stages, ultimately advancing the management and treatment of LBD.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/the-pro-lbd-study-investigating-early-detection-prognosis-and-biomarkers-of-prodromal-lewy-body-diseases/