A Phase 3 interventional study of Placebo and Pimavanserin 34 mg in Dementia-related Psychosis, sponsored by ACADIA Pharmaceuticals Inc.. Completed at 83 sites in 13 countries. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-06-21.
Sponsored by ACADIA Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's enrollment of 392 is above the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →ACADIA Pharmaceuticals Inc. is the lead sponsor of 41 studies on the registry; 5 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Placebo
Drug: Pimavanserin 34 mg · Drug: Pimavanserin 20 mg
Placebo, tablets, once daily by mouth
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth
Pimavanserin 20 mg total daily dose, tablets, once daily by mouth
Time From Randomization to Relapse in the Double-blind (DB) Period
The time from randomization to relapse in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by the hazard ratio (HR). Relapse was defined as (1) ≥30% increase in SAPS-H+D total score from DB baseline (BL) and CGI-I score ≥6 relative to DB BL, (2) treatment with antipsychotic for dementia-related delusions/hallucinations, (3) treatment/study discontinuation due to lack of efficacy, and/or (4) hospitalization for worsening dementia-related psychosis. SAPS-H+D is a 20-item scale; the total score is the sum of the 20 item scores (range 0-100); higher scores denote more severe symptoms. CGI-I is a clinician-rated 7-point scale to rate improvement in hallucinations/delusions relative to BL (range 1-7); higher scores denote less improvement or worsening. A pre-specified IA was conducted after accrual of 40 adjudicated relapse events. The prespecified stopping criterion was met; the study was stopped for efficacy.
Time frame: From randomization in the DB period through 26 weeks
Time From Randomization to Discontinuation From the DB Period for Any Reason
The endpoint of time from randomization to discontinuation from the DB period for any reason (other than termination of the study by the sponsor) was compared between treatment groups using a Cox regression model. The treatment effect was measured by the HR.
Time frame: From randomization in the DB period through 26 weeks
The study was performed in subjects with all-cause dementia according to NIA-AA guidelines, including dementia associated with Parkinson's disease, dementia with Lewy Bodies, possible or probable Alzheimer's disease, frontotemporal degeneration spectrum disorder, and/or vascular dementia, and were to have had at least a 2-month history of psychotic symptoms.
| Milestone | Pimavanserin Open-Label Period | Pimavanserin Double-Blind Period | Placebo Double-Blind Period |
|---|---|---|---|
| Started | 392 | 0 | 0 |
| Completed | 217 | 0 | 0 |
| Not completed | 175 | 0 | 0 |
| Withdrew: Lack of response in ol period | 70 | 0 | 0 |
| Withdrew: Adverse event | 27 | 0 | 0 |
| Withdrew: Death | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Non-compliance with study drug | 5 | 0 | 0 |
| Withdrew: Use of prohibited medication | 1 | 0 | 0 |
| Withdrew: Protocol violation | 4 | 0 | 0 |
| Withdrew: Withdrawal by subject | 17 | 0 | 0 |
| Withdrew: Not otherwise specified | 8 | 0 | 0 |
| Withdrew: Administrative discont. at study termination | 41 | 0 | 0 |
| Milestone | Pimavanserin Open-Label Period | Pimavanserin Double-Blind Period | Placebo Double-Blind Period |
|---|---|---|---|
| Started | 0 | 105 | 112 |
| Completed | 0 | 44 | 35 |
| Not completed | 0 | 61 | 77 |
| Withdrew: Relapse | 0 | 15 | 34 |
| Withdrew: Adverse event | 0 | 3 | 1 |
| Withdrew: Noncompliance with study drug | 0 | 0 | 1 |
| Withdrew: Use of prohibited medication | 0 | 1 | 0 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 6 | 4 |
| Withdrew: Not otherwise specified | 0 | 1 | 5 |
| Withdrew: Administrative discont. at study termination | 0 | 35 | 31 |
The time from randomization to relapse in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by the hazard ratio (HR). Relapse was defined as (1) ≥30% increase in SAPS-H+D total score from DB baseline (BL) and CGI-I score ≥6 relative to DB BL, (2) treatment with antipsychotic for dementia-related delusions/hallucinations, (3) treatment/study discontinuation due to lack of efficacy, and/or (4) hospitalization for worsening dementia-related psychosis. SAPS-H+D is a 20-item scale; the total score is the sum of the 20 item scores (range 0-100); higher scores denote more severe symptoms. CGI-I is a clinician-rated 7-point scale to rate improvement in hallucinations/delusions relative to BL (range 1-7); higher scores denote less improvement or worsening. A pre-specified IA was conducted after accrual of 40 adjudicated relapse events. The prespecified stopping criterion was met; the study was stopped for efficacy.
| days | Pimavanserin Double-Blind Period | Placebo Double-Blind Period |
|---|---|---|
| Time From Randomization to Relapse in the Double-blind (DB) Period | NA (NA to NA) | NA (NA to NA) |
The endpoint of time from randomization to discontinuation from the DB period for any reason (other than termination of the study by the sponsor) was compared between treatment groups using a Cox regression model. The treatment effect was measured by the HR.
| days | Pimavanserin Double-Blind Period | Placebo Double-Blind Period |
|---|---|---|
| Time From Randomization to Discontinuation From the DB Period for Any Reason | NA (NA to NA) | NA (NA to NA) |
Collected over Adverse Events (AEs) were to be documented through 30 days after the last dose in the study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pimavanserin Open-Label Period | 1/392 (0.3%) | 20/392 (5.1%) | 24/392 (6.1%) |
| Pimavanserin Double-Blind Period | 1/105 (1%) | 5/105 (4.8%) | 16/105 (15.2%) |
| Placebo Double-Blind Period | 0/112 (0%) | 4/112 (3.6%) | 9/112 (8%) |
| Event | Pimavanserin Open-Label Period | Pimavanserin Double-Blind Period | Placebo Double-Blind Period |
|---|---|---|---|
| Urinary tract infectionInfections and infestations | 2/392 | 1/105 | 1/112 |
| SepsisInfections and infestations | 0/392 | 1/105 | 0/112 |
| Septic encephalopathyInfections and infestations | 0/392 | 1/105 | 0/112 |
| Prostate cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/392 | 1/105 | 0/112 |
| Metabolic encephalopathyNervous system disorders | 0/392 | 1/105 | 0/112 |
| Transient ischaemic attackNervous system disorders | 0/392 | 1/105 | 0/112 |
| AgressionPsychiatric disorders | 1/392 | 1/105 | 0/112 |
| HaematemesisGastrointestinal disorders | 1/392 | 0/105 | 1/112 |
| PneumoniaInfections and infestations | 0/392 | 0/105 | 1/112 |
| Decreased appetiteMetabolism and nutrition disorders | 0/392 | 0/105 | 1/112 |
| Event | Pimavanserin Open-Label Period | Pimavanserin Double-Blind Period | Placebo Double-Blind Period |
|---|---|---|---|
| HeadacheNervous system disorders | 6/392 | 10/105 | 5/112 |
| Urinary tract infectionInfections and infestations | 18/392 | 6/105 | 4/112 |
Patients who entered the respective study period and received at least one dose of study medication
| Age, Continuous(years) | Pimavanserin Open-Label Period |
|---|---|
| Mean | 74.5 ± 8.28 |
| Sex: Female, Male(Participants) | Pimavanserin Open-Label Period |
|---|---|
| Female | 229 |
| Male | 163 |
| Race (NIH/OMB)(Participants) | Pimavanserin Open-Label Period |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 371 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Pimavanserin Open-Label Period |
|---|---|
| United States | 118 |
| Czechia | 11 |
| Ukraine | 74 |
| United Kingdom | 8 |
| Spain | 9 |
| Poland | 42 |
| Italy | 13 |
| Slovakia | 35 |
| Bulgaria | 3 |
| Chile | 27 |
| France | 7 |
| Serbia | 44 |
| Germany | 1 |
| Dementia severity(Participants) | Pimavanserin Open-Label Period |
|---|---|
| Mild | 65 |
| Moderate | 275 |
| Severe | 52 |
| Scale for the Assessment of Positive Symptoms-Hallucinations+Delusions (SAPS-H+D) total score(Score on a scale) | Pimavanserin Open-Label Period |
|---|---|
| Mean | 24.4 ± 9.22 |
| Clinical Global Impression-Severity (CGI-S)(units on a scale) | Pimavanserin Open-Label Period |
|---|---|
| Mean | 4.7 ± 0.69 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Pimavanserin