ACP-204 in Adults With Alzheimer's Disease Psychosis
ConditionAlzheimer's Disease Psychosis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age55-95
SponsorACADIA Pharmaceuticals Inc.
About this trial
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP
* Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.
All 3 substudies will be analyzed independently of each other.
Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting
Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria
Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)
Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD
Disqualifiers
Requires treatment with a medication prohibited by the protocol
Is in hospice and receiving end-of-life palliative care, or has become bedridden
Requires skilled nursing care
Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia
Trial design
Design model
Parallel
Treatments tested in this trial
ACP-204
DrugACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
Placebo
DrugACP-204 matching placebo
Treatment groups
1,074 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
Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)
The SAPS-H+D subscales are a measure of two psychotic symptoms: hallucinations and delusions. The SAPS-H+D total score is the sum of the scores of the Hallucinations and Delusions subscales. The hallucinations domain score (SAPS-H) is the sum of the 7 hallucinations item scores, and the delusions domain core (SAPS-D) is the sum of the 13 delusions item scores.
Time frame
From baseline to Week 6Secondary outcomes
1
Clinical Global Impression-Severity in the ADP context (CGI-S-ADP) score
The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the subject's symptoms at the time of assessment using the Investigator's judgment and past experience with subjects who have the same disorder. The CGI-S-ADP scale is the CGI-S scale applied in the ADP context, in which hallucinations and delusions are the symptoms of interest.
Time frame
Baseline to Week 6Sponsors and contacts
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Source ClinicalTrials.gov