(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

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).

Eligibility

  • 40 years to 85 years old
  • Have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment.
  • Meet diagnostic criteria for PD per MDS criteria or DLB per 4th Consensus Report of the DLB Consortium.
  • Have a score on the MoCA of 10 - 23.
  • Are Modified Hoehn and Yahr Stages 0 - 4.
  • If on anti-parkinsonian agents, participants must be on stable dosage for at least 3 weeks prior to screening, and should remain on stable doses during the course of the study.
  • If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
  • If on antidepressant medications, participants must be on stable dosage for at least 3 weeks prior to screening and should 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, participants must be on stable dosage for 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
  • If on antihypertensive medications, participants must be on stable dosage for at least 3 weeks prior to screening.
  • Men should use appropriate contraception.
  • All participants must have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week) and will accompany the participant to screening, baseline, day 7, day 42, day 84 and follow-up.
  • Have a blood pressure (BP) or pulse rate at screening and randomization, as determined by three sequential BP/pulse rate measurements in a seated position:

Participants <60 years old:

  • A mean systolic BP less than or equal to 140 millimeters of mercury (mmHg), a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less than or equal 90 beats/minute in a seated position.
  • Each of the 3 systolic BP measurement must be less than 180 mmHg

Participants ≥60 years old:

  • A mean systolic BP less than or equal to 150 mmHg, a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less than or equal to 90 beats/min in a seated position.
  • Each of the 3 systolic BP measurement must be less than 180 mmHg

Additional criteria may apply.

Contact

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, Parkinson's disease, Parkinson's disease - resources

Principal Investigator

Adolfo Ramirez-Zamora, MD

Department

Neurology

Contact Information

adrienne.royster@neurology.ufl.edu

(352) 294-8886


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