A Study of TAK-071 in People With Parkinson Disease
Condition: Parkinson Disease; Healthy Participants
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      It is hoped that TAK-071 will help people with Parkinson's disease to walk with better
      balance. The main aim of the study is to check if there is a difference in how participants
      walk after treatment with TAK-071. Another aim is to see if it improves how participants
      think and remember.

      At the first visit, the study doctor will check who can take part. Participants who can take
      part will be picked for 1 of 2 groups by chance.

      Both groups will have 2 treatments but in a different order. The treatments are TAK-071
      tablets or placebo. In this study, a placebo will look like the TAK-071 but will not have any
      medicine in it.

      One group will take TAK-071 for 6 weeks, have at least a 3-week break, then take a placebo
      for 6 weeks. The other group will take a placebo for 6 weeks, have at least a 3-week break,
      then take TAK-071 for 6 weeks. The participants will not know the order of their 2
      treatments, nor will their study doctors. This is to help make sure the results are more
      reliable.

      The participants will visit the clinic at the beginning and end of each treatment for a
      check-up. 14 days after the 2nd treatment, clinic staff will telephone the participants for a
      final check-up.
    

Detailed 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 and who are not concurrently
      taking acetylcholinesterase inhibitors. The study will look at the efficacy and safety of
      TAK-071 in participants with PD who take TAK-071 versus placebo.

      The study will also evaluate the PK of TAK-071 in healthy participants (sentinel cohort)
      older than 55 years.

      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 ≤ 85 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. Participants with
      maximum age of 66 to 85 years, inclusive, will be enrolled at a dose of 5 mg, and the dose
      for subjects aged 40 to 65 years, inclusive, will be 7.5 mg. 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 <=85 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.
    

Intervention name(s): TAK-071; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-071 tablet.; TAK-071 placebo-matching tablet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy