A Phase 3 interventional study of Pimavanserin in Neuropsychiatric Symptoms Related to Neurodegenerative Disease, sponsored by ACADIA Pharmaceuticals Inc.. Completed at 88 sites in 12 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by ACADIA Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the long-term safety and tolerability of pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease exposed to open-label pimavanserin for up to 52 weeks.
370 studies on the registry are indexed under Neurodegenerative Diseases; 145 are open to participants now.
This study's enrollment of 595 is above the median of 53 across 204 interventional studies indexed under Neurodegenerative Diseases.
Browse Neurodegenerative Diseases studies →ACADIA Pharmaceuticals Inc. is the lead sponsor of 41 studies on the registry; 5 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Has a designated study partner/caregiver who meets the following requirements:
Exclusion Criteria:
Has any of the following ECG results at the EOT/ET visit of the antecedent study:
a. If the subject is not on citalopram, escitalopram, or venlafaxine:
i. QTcF >450 ms, if QRS duration \<120 ms
ii. QTcF >470 ms, if QRS duration ≥120 ms
b. If the subject is on citalopram, escitalopram, or venlafaxine:
i. QTcF >425 ms, if QRS duration \<120 ms
ii. QTcF >450 ms, if QRS duration ≥120 ms
Has clinically significant laboratory abnormalities in the antecedent study that, in the judgment of the Investigator or Medical Monitor, would either:
Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
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Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response.
Drug: Pimavanserin
• Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response.
Treatment-emergent Adverse Events (TEAEs)
Number (%) of patients experiencing at least one TEAE
Time frame: Treatment period and Follow-up period: 56 weeks
This was an open-label extension study to evaluate the long-term safety and tolerability of pimavanserin in patients with neuropsychiatric symptoms related to neurodegenerative disease, who had completed an antecedent study (ACP-103-046) or had participated in a pimavanserin study that the sponsor terminated early.
| Milestone | Pimavanserin |
|---|---|
| Started | 595 |
| Completed | 452 |
| Not completed | 143 |
| Withdrew: Adverse event | 32 |
| Withdrew: Death | 9 |
| Withdrew: Lack of efficacy | 9 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Noncompliance with study drug | 6 |
| Withdrew: Use of prohibited medication | 3 |
| Withdrew: Physician decision | 5 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Consent withdrawn by patient or legally accepted representative | 29 |
| Withdrew: Not further specified | 43 |
Number (%) of patients experiencing at least one TEAE
| Participants | Pimavanserin |
|---|---|
| Treatment-emergent Adverse Events (TEAEs) | 238 |
Collected over Treatment period and Follow-up period: 56 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pimavanserin | 11/595 (1.8%) | 37/595 (6.2%) | 0/595 (0%) |
| Event | Pimavanserin |
|---|---|
| Cerebrovascular accidentNervous system disorders | 3/595 |
| Cardiac failureCardiac disorders | 2/595 |
| Cardiac failure congestiveCardiac disorders | 2/595 |
| PneumoniaInfections and infestations | 2/595 |
| Femur fractureInjury, poisoning and procedural complications | 2/595 |
| Brain oedemaNervous system disorders | 2/595 |
| AgitationPsychiatric disorders | 2/595 |
| BradycardiaCardiac disorders | 1/595 |
| Cardiac arrestCardiac disorders | 1/595 |
| Left ventricular failureCardiac disorders | 1/595 |
All patients enrolled and treated
| Age, Categorical(Participants) | Pimavanserin |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 87 |
| >=65 years | 508 |
| Age, Continuous(years) | Pimavanserin |
|---|---|
| Mean | 72.2 ± 6.69 |
| Sex: Female, Male(Participants) | Pimavanserin |
|---|---|
| Female | 348 |
| Male | 247 |
| Race (NIH/OMB)(Participants) | Pimavanserin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 13 |
| White | 561 |
| More than one race | 0 |
| Unknown or Not Reported | 20 |
| Region of Enrollment(participants) | Pimavanserin |
|---|---|
| Colombia | 16 |
| Romania | 3 |
| United States | 197 |
| Czechia | 30 |
| Ukraine | 81 |
| Poland | 90 |
| Mexico | 9 |
| South Africa | 11 |
| Georgia | 25 |
| Bulgaria | 29 |
| Serbia | 36 |
| Russia | 68 |
| Mini Mental State Examination total score(units on a scale) | Pimavanserin |
|---|---|
| Mean | 20.0 ± 5.16 |
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ACADIA Pharmaceuticals Inc.