Falls and Cognition in Parkinson's Disease (TAKEDA)

Condition: Parkinson’s disease

Eligibility

Key Inclusion Criteria:

  • Diagnosis of Parkinson’s disease (PD) according to Movement Disorder Society (MDS) clinical diagnostic criteria for PD. Participants with Dementia with Lewy Bodies are also eligible, consistent with MDS clinical diagnostic criteria for PD.
  • Outpatient between 40 and 85 years old
  • Has a study partner who is involved in the daily care of the participant to provide reliable information on falls and assist the subject with at-home assessments, medication compliance, and attending study visits

Key Exclusion Criteria:

  • Parkinsonism due to other causes besides PD
  • History of surgery for PD (i.e., Deep Brain Stimulation)
  • Severe dyskinesias affecting gait

Study Name

A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover, Phase II 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 (IRB no. 00001054) 

Summary

The purpose of this study is to evaluate an investigational drug called TAK-071 (Takeda study medication) as a possible treatment for people with Parkinson’s disease who have a history of falls associated with cognitive decline. The study will assess the effectiveness, safety, and tolerability of TAK-071, as well as collect information on the amount of TAK-071 in the blood and how the body reacts to the drug.

Researchers will also examine specific chemical indicators (also known as biomarkers) that can be found in blood samples and may allow doctors to identify patients who are more likely to respond to or develop side effects after taking TAK-071.

Principal Investigator