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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 Disease Patients With Cognitive Impairment and an Elevated Risk of Falls


Brief Summary:

The purpose of this study is to evaluate the effect of TAK-071 when compared to placebo on
gait in participants with PD who also have cognitive impairment. Safety and tolerability of
TAK-071 will also be established in participants with PD.


Key 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. 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). Participants who require aids for walking can be included as long as they can complete the walk test without aid. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply Key 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply


  • Collaborative Neuroscience Network, LLC, Torrance, California, United States, 90502
  • Cedars Sinai Medical Center, West Hollywood, California, United States, 90048-1804
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