A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB) (PRESENCE)

A randomized placebo-controlled trial to evaluate the safety and efficacy of three doses of study drug LY3154207 treated for 12 weeks in participants with mild-to-moderate dementia associated with LBD (PDD or DLB).

Trial Summary

Age Range
40 - 85 years
Conditions the trial is for
Lewy Body Dementia
What the trial is testing?
Mevidalen hydroxybenzoate
Could I receive a Placebo?
Yes
Enrollment Goal
344
Trial Dates
Nov 9, 2017 - Jul 10, 2020
How long will I be in the trial?
Your participation could last approximately 18 weeks and include 12 visits to the study center.
Trial Phase
II

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participant must have dementia

  • Participant must have Parkinson's Disease or dementia with Lewy bodies

  • Participants on anti-parkinsonian agents, must be on stable doses for at least 3 weeks prior to entering study

  • Participants on antidepressant medications, must be on stable doses for at least 3 weeks prior to entering study

  • Participants on blood pressure lowering medications, must be on stable doses for at least 3 weeks prior to entering study

  • Male participant must use appropriate contraception

  • Female participant must not be of childbearing potential

  • Participant must have a reliable caregiver who is in frequent contact with participant and will accompany participant to select visits

Participants Must Not:

  • Participant must not have a history of stroke in the last 6 months

  • Participant must not have a current or any previous diagnosis of bipolar disorder, schizophrenia, or other primary psychotic disorder

  • Participant must not have a history of substance abuse within the past 1 year, and/or substance dependence within the past 1 year, not including caffeine and nicotine

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