A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis
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ClinicalTrials.gov Identifier: NCT02035553 |
Recruitment Status :
Completed
First Posted : January 14, 2014
Results First Posted : October 25, 2017
Last Update Posted : October 25, 2017
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Sponsor:
ACADIA Pharmaceuticals Inc.
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
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Tracking Information | |||
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First Submitted Date ICMJE | January 13, 2014 | ||
First Posted Date ICMJE | January 14, 2014 | ||
Results First Submitted Date ICMJE | September 28, 2017 | ||
Results First Posted Date ICMJE | October 25, 2017 | ||
Last Update Posted Date | October 25, 2017 | ||
Study Start Date ICMJE | November 2013 | ||
Actual Primary Completion Date | September 28, 2016 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Antipsychotic Efficacy [ Time Frame: Day 43 ] Change from Baseline to Day 43 in the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) psychosis score (Delusions [Domain A]+Hallucinations [Domain B]) in the Full Analysis Set (FAS). The NPI-NH is a questionnaire that quantifies behavioral changes in dementia in nursing home patients and evaluates 12 behavioral domains. For each of the 12 behavioral domains the Frequency (scale:1=occasionally to 4=very frequently) is multiplied by the Severity (scale:1=Mild to 3=Severe) to obtain a domain score (frequency x severity), The NPI-NH Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual domain scores, to yield a possible total score of 0 to 24. Lower scores correspond to less severity. A negative change score from baseline indicates improvement.
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Original Primary Outcome Measures ICMJE |
Efficacy will be assessed using the Neuropsychiatric Inventory - Nursing Home Version, the Cohen-Mansfield Agitation Inventory - Short Form, and the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change. [ Time Frame: 12 weeks ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis | ||
Official Title ICMJE | A Single Center, Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Psychosis in Alzheimer's Disease | ||
Brief Summary | This study will evaluate the safety and efficacy of pimavanserin 40 mg compared to placebo in patients with Alzheimer's disease psychosis. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Alzheimer's Disease Psychosis | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
181 | ||
Original Estimated Enrollment ICMJE |
212 | ||
Actual Study Completion Date ICMJE | October 27, 2016 | ||
Actual Primary Completion Date | September 28, 2016 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. 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 protocol-specified entry criteria). |
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United Kingdom | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02035553 | ||
Other Study ID Numbers ICMJE | ACP-103-019 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | ACADIA Pharmaceuticals Inc. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | ACADIA Pharmaceuticals Inc. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | ACADIA Pharmaceuticals Inc. | ||
Verification Date | September 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |