A Study Of TAK-071 In People With Parkinson Disease

Summary

Participation Requirements

Description

The drug being tested in this study is TAK-071. TAK-071 is being tested to treat people with PD who have cognitive impairment and are at risk for falls. The study will evaluate the PK of TAK-071 in healthy participants (sentinel cohort) older than 55 years and will look at the efficacy and safety of...

The drug being tested in this study is TAK-071. TAK-071 is being tested to treat people with PD who have cognitive impairment and are at risk for falls. The study will evaluate the PK of TAK-071 in healthy participants (sentinel cohort) older than 55 years and will look at the efficacy and safety of TAK-071 in participants with PD who take TAK-071 versus placebo. The study will enroll approximately 74 participants. An initial sentinel cohort of 10 healthy participants will be included to estimate age effects. Participants aged 56 to 75 years will be randomly assigned in 3:1 ratio to one of the two treatments: Sentinel Cohort: TAK-071 7.5 mg Sentinel Cohort: Placebo Enrolment for participants aged 40 to <=65 years in the main study will start simultaneously with sentinel cohort.. Based on PK, safety, and physiologically based PK modelling data from sentinel cohort, dosing will be decided for the remaining participants. If older participants are expected to remain below the exposure caps then participants with maximum age of not more than 75 years may be enrolled and dose may be modified after analysis of data from the sentinel cohort (7.5 or 5 mg once daily, potentially depending on age). All participants will be asked to take one tablet at the same time each day throughout the study. The remaining participants aged 40 years to <=65 years will be randomly assigned in 1:1 ratio to one of two treatment sequences in crossover design: TAK-071 + Placebo Placebo + TAK-071 The study will be conducted in the United States. The minimum time to participate in this study is approximately 15 weeks. Participants will make multiple visits to the clinic and will have home assessments during the third Week of each 6-week treatment period, and will be contacted by telephone at 14 days after completion of the last period for a follow-up assessment.

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