Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
ConditionLewy Body Dementia Psychosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age55-84
SponsorACADIA Pharmaceuticals Inc.
About this trial
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator
Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study
Can complete all study visits with a study partner/caregiver
The subject's LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent.
Disqualifiers
Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
Is in hospice, is receiving end-of-life palliative care, or is bedridden
Has a heart rate <50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated.
Has a BMI <18.5 kg/m2 or known unintentional weight loss ≥7% of body weight over past 6 months
Trial design
Design model
Single group
Treatments tested in this trial
ACP-204
DrugProvided as 1 capsule, to be taken orally once daily
Treatment groups
126 Participants
are divided into 1 treatment groupGroup A: ACP-204Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects who experience treatment-emergent adverse events (TEAEs)
Time frame
52 weeksSponsors and contacts
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Source ClinicalTrials.gov