Falls and Cognition in Parkinson's Disease (TAKEDA)

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.


Inclusion Criteria

  • Is an outpatient of any sex aged between 40 and ≤ 85 years, inclusive, at the time of consent.
  • Has a diagnosis of PD according to Movement Disorders Society (MDS) clinical diagnostic criteria for PD. Participants with DLB (i.e., 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.
  • Has Hoehn and Yahr stage ≥2 and <4 at the screening visit.
  • Has elevated risk for falls as indicated by at least 1 fall in the last 12 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 and are at continued elevated risk of falls per investigator judgment. Investigator judgment on fall risk may be informed by information such as, but not limited to, history, physical examination and/or a score ≥2 on item 3.10 on Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III.

Study Location(s)

Beverly

More about this Clinical Trial

Full 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 Disease Patients With Cognitive Impairment and an Elevated Risk of Falls

Details
Disease Type/Condition

Parkinson's Disease

Principal Investigator

Tagliati, Michele

Age Group

Adult

Phase

II

IRB Number

STUDY00001054

ClinicalTrials.gov ID
NCT04334317
Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Parkinson's Disease

Principal Investigator

Tagliati, Michele

Age Group

Adult

Phase

II

IRB Number

TAK-071-2002

ClinicalTrials.gov ID

NCT04334317

Key Eligibility
ClinicalTrials.gov
Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?