(The PRESENCE Study) Effect of LY3154207 on Cognition in Mild-to-Moderate Dementia Due to Lewy Body Dementia (LBD) Associated with Idiopathic Parkinson’s Disease (PD) or Dementia with Lewy Bodies (DLB)

Purpose

The purpose of this additional research study is to determine whether LY3154207 has an effect on your blood pressure and pulse rate during normal activities, especially while you are asleep at night.

Procedures

  • This is for participants already enrolled in the PRESENCE study. Questions about the main study? Contact the study team below.
  • At the end of Visit 2 or before Visit 3, and at the end of Visits 3, 7, and 10, your study team will place an ambulatory blood pressure device on you and talk to you about how it works and how to take care of it.
  • This device has a cuff that fits onto your arm.
  • The cuff is attached to a monitoring device in a pouch that you will wear on a strap around your shoulder or waist, or on your belt.
  • You will wear the device home from the study site and keep it on for 24 to 48 hours.
  • Your study team will tell you how long you should keep it on and let you know how to take it off.
  • The device will automatically take your blood pressure. It will take your blood pressure every 30 minutes between the hours of 8 a.m. and 10 p.m. and every 60 minutes between 10 p.m. and 8 a.m.

Eligibility

  • Ages 40 - 85 years old
  • Have idiopathic PD per MDS criteria (Postuma et al. 2015) with at least 2 years of PD symptoms
  • Have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment.
  • Have a MoCA score of 10 to 23 at the time of screening.
  • Are Modified Hoehn and Yahr Stages 1 to 4.
  • Have a BP or pulse rate at Visit 1 and Visit 3, as determined by 3 sequential BP/pulse rate measurements in the seated position
  • If on anti-parkinsonian agents, subjects must be on stable dosage for at least 4 weeks prior to Visit 2, anticipated that no changes will be needed during the course of the study.
  • If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), subjects must be on stable dosage for at least 8 weeks prior to Visit 2 and expected to remain at a stable dosage during the course of the study.
  • If on antidepressant medications, subjects must be on stable dosage for at least 8 weeks prior to Visit 2 and expected to remain at a stable dosage during the course of the study.
  • If on clozapine, quetiapine, and pimavanserin to address drug-induced or disease-related psychosis, subjects must be on stable dosage for 4 weeks prior to Visit 2 and expected to remain at a stable dosage during the course of the study.
  • If on antihypertensive medications, subjects must be on stable dosage for at least 3 months prior to Visit 1.

For questions about the study, please contact Adrienne Royster: 

Age

18 to 65
65 and over

Gender

Male
Female

Monetary compensation

Yes

Can be done from home

No

Keywords

Neurology, Dementia, Dementia - behavior and sleep problems, Dementia - daily care

Principal Investigator

Adolfo Ramirez-Zamora, MD

Department

Neurology

Contact Information

adrienne.royster@neurology.ufl.edu

(352) 294-8886


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