Trial · NCT02992132
Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)
NCT02992132, Phase 2, Terminated, ACADIA Pharmaceuticals Inc.; results first posted 2019-03-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE). Trials, record NCT02992132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02992132
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)
- NCT number
- NCT02992132
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 111 participants, actual
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Conditions
- Agitation and Aggression in Alzheimer's Disease
- Interventions
- Pimavanserin 34 mg, Pimavanserin 20 mg, Placebo
- First posted
- 2016-12-14
- Last updated
- 2019-03-28
- Other registries' IDs
- eudract:2016-001127-32
- Results first posted
- 2019-03-28
- Limitations and caveats
The original study (n=432) was powered to detect a treatment effect on CMAI, however recruitment was discontinued early for business reasons and amended accordingly The final study (n=111) was no longer adequately powered to detect a treatment effect
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohen-Mansfield Agitation Inventory (CMAI) | Baseline to 12 weeks | The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to assess agitation. Each item is rated on a 7-point scale of frequency, from least (1) to most frequent (7). Items are summed to calculate the CMAI total score. The CMAI total score has a range of 29-203 points; higher scores indicate more severe agitation |
| Secondary | Zarit Burden Interview | Baseline to 12 weeks | The Zarit Burden Interview (ZBI) assess the stresses experienced by caregivers of patients with dementia. It assesses 22 questions about the impact of the patient's disabilities on the caregiver's life, each rated from least (0) to most (4) frequent. Items are summed to calculate the ZBI total score. The ZBI total score ranges from 0 to 88; higher scores denoting more stresses experienced by caregivers. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohen-Mansfield Agitation Inventory (CMAI) | Baseline to 12 weeks | Full Analysis set, i.e. patients who had been randomized and treated and had both a baseline value and at least 1 post-baseline value for the CMAI total score. | score on a scale | MEAN |
| SECONDARY | Zarit Burden Interview | Baseline to 12 weeks | Full Analysis set, i.e. patients who had been randomized and treated and had both a baseline value and at least 1 post-baseline value for the CMAI total score. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohen-Mansfield Agitation Inventory (CMAI) | Placebo | Baseline | 70.3 | Standard Error 4.5 | score on a scale |
| Cohen-Mansfield Agitation Inventory (CMAI) | Pimavanserin 20 mg | Baseline | 56.9 | Standard Error 2.2 | score on a scale |
| Cohen-Mansfield Agitation Inventory (CMAI) | Pimavanserin 34 mg | Baseline | 68.0 | Standard Error 3.3 | score on a scale |
| Cohen-Mansfield Agitation Inventory (CMAI) | Placebo | Week 12 | 54.3 | Standard Error 4.3 | score on a scale |
| Cohen-Mansfield Agitation Inventory (CMAI) | Pimavanserin 20 mg | Week 12 | 52.5 | Standard Error 4.3 | score on a scale |
| Cohen-Mansfield Agitation Inventory (CMAI) | Pimavanserin 34 mg | Week 12 | 53.7 | Standard Error 3.0 | score on a scale |
| Cohen-Mansfield Agitation Inventory (CMAI) | Placebo | Week 12 change from baseline | -16.8 | Standard Error 5.0 | score on a scale |
| Cohen-Mansfield Agitation Inventory (CMAI) | Pimavanserin 20 mg | Week 12 change from baseline | -3.7 | Standard Error 3.7 | score on a scale |
| Cohen-Mansfield Agitation Inventory (CMAI) | Pimavanserin 34 mg | Week 12 change from baseline | -12.3 | Standard Error 2.7 | score on a scale |
| Zarit Burden Interview | Placebo | Baseline | 41.5 | Standard Error 2.6 | score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 40 | |
| Overall Study | STARTED | Pimavanserin 20 mg | 35 | |
| Overall Study | STARTED | Pimavanserin 34 mg | 36 | |
| Overall Study | COMPLETED | Placebo | 27 | |
| Overall Study | COMPLETED | Pimavanserin 20 mg | 27 | |
| Overall Study | COMPLETED | Pimavanserin 34 mg | 29 | |
| Overall Study | NOT COMPLETED | Placebo | 13 | |
| Overall Study | NOT COMPLETED | Pimavanserin 20 mg | 8 | |
| Overall Study | NOT COMPLETED | Pimavanserin 34 mg | 7 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 40 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Pimavanserin 20 mg | 2 | 35 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Pimavanserin 34 mg | 0 | 36 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 40 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Pimavanserin 20 mg | 2 | 35 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Pimavanserin 34 mg | 2 | 36 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 40 | 1 |
| other | Constipation | Gastrointestinal disorders | Pimavanserin 20 mg | 2 | 35 | 2 |
| other | Constipation | Gastrointestinal disorders | Pimavanserin 34 mg | 2 | 36 | 2 |
| other | Gastrointestinal haemorrhage | Gastrointestinal disorders | Placebo | 0 | 40 | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 40 |
| Total, all-cause mortality | Pimavanserin 20 mg | 0 | 35 |
| Total, all-cause mortality | Pimavanserin 34 mg | 0 | 36 |
| Total, other adverse events | Placebo | 11 | 40 |
| Total, other adverse events | Pimavanserin 20 mg | 15 | 35 |
| Total, other adverse events | Pimavanserin 34 mg | 15 | 36 |
| Total, serious adverse events | Placebo | 3 | 40 |
| Total, serious adverse events | Pimavanserin 20 mg | 4 | 35 |
| Total, serious adverse events | Pimavanserin 34 mg | 3 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02992132
GET https://conductscience.org/api/trials/v1/NCT02992132/events?page=2