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
Lead Researcher: Karlo J Lizarraga mendoza
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.
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Lizárraga KJ, Gnanamanogaran B, Al-Ozzi TM, Cohn M, Tomlinson G, Boutet A, Elias GJB, Germann J, Soh D, Kalia SK, Hodaie M, Munhoz RP, Marras C, Hutchison WD, Lozano AM, Lang AE, Fasano A. "Lateralized Subthalamic Stimulation for Axial Dysfunction in Parkinson's Disease: A Randomized Trial." Movement disorders : official journal of the Movement Disorder Society.. 2022 Feb 13; Epub 2022 Feb 13.
Tarolli CG, Lizarraga KJ. "Approach to the Patient with Gait Disturbance." Seminars in neurology.. 2021 Dec 0; 41(6):717-730. Epub 2021 Nov 26.
Zumaeta K, Romero SE, Torres E, Urdiales L, Ramirez A, Camargo I, Lizarraga KJ, Castaneda B. "Combining inertial sensors and optical flow to assess finger movements: Pilot study for telehealth applications." . 2021 Nov 0; 2021:2409-2412.
Books & Chapters
Chapter Title: Subacute Sclerosing Panencephalitis
Book Title: Reference Module in Neuroscience and Biobehavioral Psychology
Author List: Lizarraga KJ, Gutierrez J, Singer C
Published By: El Sevier 2017
Chapter Title: Molecular Imaging of the Brain with PET
Book Title: Youmans and Winn Neurological Surgery
Author List: DeSalles AA, Lizarraga KJ, Gorgulho A, Melega WP
Published By: El Sevier 2016
Chapter Title: Applications of Nanotechnology in Movement Disorders
Book Title: The Textbook of Nanoneuroscience and Nanoneurosurgery
Author List: Pezeshkian P, Lizarraga KJ, Gorgulho A, DeSalles AF
Published By: CRC Press 2013
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