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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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease Psychosis | Drug: Pimavanserin tartrate Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 181 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | September 28, 2016 |
Actual Study Completion Date : | October 27, 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo, two tablets, once daily by mouth
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Drug: Placebo
Placebo, two tablets, once daily by mouth |
Experimental: Pimavanserin 40 mg
Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
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Drug: Pimavanserin tartrate
Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
Other Name: ACP-103 |
- 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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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must be 50 years of age or older with NINCDS-ADRDA defined possible or probable AD
- Patient must have psychotic symptoms that developed after the diagnosis of AD was established. These symptoms must include visual and/or auditory hallucinations, and/or delusions
- Patient must have been a nursing home resident for ≥ 4 weeks prior to randomization, not bedridden and expected to remain in the facility throughout the study
- Patient must have actively experienced and verbally communicated psychotic symptoms during the month prior to the Screening visit and weekly during the previous 2 weeks prior to Baseline
- If patient is on acetylcholinesterase inhibitor (AChEI) therapy and/or memantine, must be on stable doses for 3 months prior to the Baseline visit and during the study
- Patient is willing and able to provide informed consent. If the subject is unable to provide written consent due to the severity of dementia, consent must be given by a legally authorized representative
Exclusion Criteria:
- Patient has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Alzheimer's disease including, but not limited to, schizophrenia or bipolar disorder
- Patient is unable to communicate verbally
- Patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study
- Patient has had a myocardial infarction in the last six months
- Patient has moderate to severe congestive heart failure
- Patient has any surgery planned during the screening, treatment, or follow-up periods that could interfere with participation in the study per the protocol assessments
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035553
United Kingdom | |
London, United Kingdom |
Responsible Party: | ACADIA Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT02035553 |
Other Study ID Numbers: |
ACP-103-019 |
First Posted: | January 14, 2014 Key Record Dates |
Results First Posted: | October 25, 2017 |
Last Update Posted: | October 25, 2017 |
Last Verified: | September 2017 |
Alzheimer Disease Psychotic Disorders Mental Disorders Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Schizophrenia Spectrum and Other Psychotic Disorders Pimavanserin |
Antiparkinson Agents Anti-Dyskinesia Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |