Lansing, Illinois

Efficacy Study of Kinto Care Coaching for Dementia Family Caregivers

The study will include 300 family caregivers drawn from throughout the US, who will engage remotely with the coaches (and one another) using zoom and Kinto's mobile caregiver app. Caregivers will be randomly assigned to one of two groups to evaluate the impact of the program by making a comparison of those caregivers who received the program (Group 1. and those caregivers who will not receive the program (Group 2). Caregivers assigned to Group 2, the control condition, will be eligible to receive a modified version of the program after completion of the study and data collection protocols. The intervention is a care coaching program that assists caregivers with their general caregiving goals and financial caregiving goals. Caregivers will attend a one-on-one care coaching session conducted via Zoom for 60-75 minutes with a care coach and will engage with their care coach through chat-based interactions after completing the session. If requested, up to two additional care coaching sessions will be scheduled. Caregivers also will have the opportunity to attend up to 6 weekly support groups with other caregivers facilitated by a care coach and receive a variety of digital resources through the mobile app. As guided by the NIH Stage Model for Behavioral Intervention Development, the primary goal of the Phase 2 study is to examine the efficacy of the program on select outcomes for caregivers (i.e., Stage III Real-World Efficacy). As such, the selected data collection periods of T1 (prior to the intervention), T2 (immediately following the initial six week intervention period) and T3 (45 days following this date) will evaluate the immediate and short-term efficacy of the program. Recruiting of caregivers is scheduled to begin in May 2023. The study plan targets recruitment of three cohorts, each with one hundred participants. The first intervention group will begin the program in August 2023. Subsequent cohorts will begin the study at 8-9 week intervals. The plan includes a contingency to run two additional cohorts (to mitigate any recruitment or retention risk). In the event that all five cohorts are used to achieve participation goals, the final cohort is scheduled to complete the intervention and survey requirements no later than August of 2024. To register visit: [alz.org/kinto](http://alz.org/kinto)

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease (REASON)

A Novel Measurement Concept to Objectively Quantify Severity of Vocal and Speech Related Symptoms Associated With Parkinson's Disease

Although multiple approaches to this problem have been proposed in addition to commercially available speech analytics platforms, there is currently no established measure which incorporates the disparate aspects of affected speech to fully characterize Parkinson's symptom progression, particularly in the prodromal phase. The measurement concept being evaluated in the present study utilizes a custom smartphone-based speech assessment tool to extract multiple hypothesis-driven acoustic features from patient speech in a real-life environment. The resultant features will be used to train a pair of supervised machine learning models to predict clinical PD symptom severity scores, and to distinguish prodromal PD patients from both healthy matched controls and PD patients in more advanced phases of disease progression.

Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD

This is a 2-part (Part A [Genetic Screening] and Part B [Double-Blind Treatment]), Phase 2, multicenter, randomized, double-blind, placebo- controlled study evaluating the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of 2 fixed dose levels of BIA 28-6156 (10 and 60 mg/day) in approximately 237 subjects with genetically confirmed GBA-PD. Part A (Genetic Screening) is identifying individuals with a PD risk- associated variant in the GBA1 gene for potential enrolment into Part B (Double-Blind Treatment) of the study. Part B consists of a screening period to ensure that all protocol inclusion/exclusion criteria for Part B of the study are met (up to 5 weeks). After screening period, eligible subjects are randomized into 1 of 3 treatment arms (BIA 28-6156 10 mg/day, BIA 28-6156 60 mg/day, or placebo) in a 1:1:1 ratio, and enter a double-blind treatment period up to 78 weeks, followed by a 30-day (4 weeks) of safety follow-up period. Subjects must be receiving a stable dose of PD medication for at least 30 days before screening (for Part B [Double-Blind Treatment]) and continue to receive their usual PD medications throughout the study.

Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET

MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments

Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation (OPTIMAL)

The goal of the OPTIMAL study is to gradually reduce anti-rejection medication(s) in liver transplant recipients over a period of time until the medication(s) are stopped. This is called immunosuppression withdrawal. As part of the OPTIMAL study, investigators will also do blood and liver biopsy tests to see whether they can identify common markers of immune systems that are able to tolerate transplanted livers without immunosuppressive medications. Identification of these markers and tests will help transplant doctors predict whether it is safe to decrease or stop anti-rejection medication(s) for future liver transplant recipients. In general, study visits will consist of a brief physical exam, and some visits will also include questionnaires as well as blood, urine, stool (fecal), and liver biopsy collections. In total, participation may last between 3.5 and 6 years. For more information, visit [ www.optimalstudy.org ](http://www.optimalstudy.org) For more information, visit [www.optimalstudy.org](https://www.optimalstudy.org)