Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
ConditionLewy Body Dementia Psychosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-84
SponsorACADIA Pharmaceuticals Inc.
About this trial
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female ≥55 years to <85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting
The subject's LAR must provide written informed consent.
The subject must provide written (if capable) informed assent per local regulations.
Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium).
Disqualifiers
Is in hospice, is receiving end-of-life palliative care, or is bedridden
Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia
Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies that could interfere with subject's ability to complete the study or comply with study procedures
Trial design
Design model
Parallel
Treatments tested in this trial
ACP-204
DrugProvided as 1 capsule, to be taken orally once daily
Placebo
DrugProvided as 1 capsule, to be taken orally once daily
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: ACP-204 30 mgExperimental treatment 1 intervention
Group B: ACP-204 60 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in SAPS-LBDP total score at Week 6
Change from Baseline in Scale for the Assessment of Positive Symptoms- Lewy Body Dementia Psychosis (SAPS-LBDP) total score at Week 6
Time frame
6 weeksSponsors and contacts
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Source ClinicalTrials.gov