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Phase 2: Effect of TAK-071 on Falls in Participants With Parkinson Disease (PD)

Anna E Morenkova


A Study On:

  • Brain - Neurologic/ Psychologic
  • Parkinson Disease

Status:

  • Open

Eligibility

40 Years to 75 Years (Adult, Older Adult)

Interested in joining this trial?

Official Title

A randomized, double blind, placebo-controlled, 2-period crossover, phase 2 study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of oral TAK-071 in Parkinson's patients with cognitive impairment and an elevated risk of falls.

Details

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 or 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 or 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.


Eligibility

You can join if...

Inclusion Criteria:

  1. Is an outpatient of any sex aged between 40 and <=65 years, inclusive, at the time of consent. At a later date, participants up to age 85 years may be enrolled.
  2. Has a diagnosis of PD according to Movement Disorders Society (MDS) clinical diagnostic criteria for PD. Participants with DLB (ie, dementia diagnosed before onset of motor symptoms or up to 1 year after onset of motor symptoms) are also eligible, consistent with MDS clinical diagnostic criteria for PD.
  3. Has Hoehn and Yahr stage >=2 and <4 at the screening visit.
  4. Has elevated risk for falls as indicated by at least 2 falls in the last 6 months before the screening visit based on the Fall History Assessment where in the opinion of the investigator the falls were a consequence of PD.
  5. Has evidence of cognitive impairment as indicated by a Montreal Cognitive Assessment (MoCA) score between 18 and 24, inclusive.
  6. Can walk without aid for 2 minutes while doing serial 3 subtraction (with site staff ensuring participant safety in case of falls). 7. Participants who require aids for walking can be included as long as they can complete the walk test without aid.

Inclusion For Healthy Participants:

  1. The participant is a healthy individual of either sex aged between 56 and 75 years, inclusive (for initial set of participant in the sentinel cohort) at the time of consent. Older participants may be enrolled after analysis of data from participants aged 56 to 75 years, inclusive.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Exclusion Criteria:

  1. Has orthostatic hypotension at screening, as defined as a decline in systolic blood pressure greater than 20 mm Hg or a decrease of 10 mm Hg in diastolic blood pressure on standing measured within 1 minute after being supine for at least 5 minutes.
  2. Has dyskinesia of sufficient severity to interfere with digital gait assessments during visits (as defined by Movement Disorders Society - Unified Parkinson's Disease Rating Scale [MDS-UPDRS] section 4.1 "Time spent with dyskinesias" and/or section 4.2 "Functional Impact of Dyskinesias" scores greater than [>] 2), or in the opinion of the investigator the participant's dyskinesia is likely to interfere with the digital gait assessments.
  3. Has significant risk factors for seizures (a history of seizures as an adult, a history of brain injury, or other risk factors deemed relevant by the investigator).
  4. Is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year before screening. participant who have positive answers on item number 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) (based on the past year) before randomization are excluded.
  5. Is unwilling or unable to discontinue taking cholinesterase inhibitors and/or moderate or strong cytochrome P-450 3A4 inhibitors or inducers at least 30 days before randomization.

Exclusion For Healthy Participants:

  1. Participants has body mass index (BMI) less than 18 or greater than 40.
  2. Has significant risk factors for seizures (a history of seizures as an adult, a history of brain injury, or other risk factors deemed relevant by the investigator).
  3. The participant is unwilling or unable to discontinue taking cholinesterase inhibitors and/or moderate or strong CYP 3A4 inhibitors or inducers at least 30 days before randomization.
    4 The participant is taking warfarin.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Get in touch with our study team