Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)
NCT ID: NCT02992132
Last Updated: 2019-03-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
111 participants
INTERVENTIONAL
2016-11-30
2018-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pimavanserin 34 mg
Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth
Pimavanserin 34 mg
Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
Pimavanserin 20 mg
Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth
Pimavanserin 20 mg
Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth
Placebo
Placebo, taken as two tablets, once daily by mouth
Placebo
Placebo, taken as two tablets, once daily by mouth
Interventions
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Pimavanserin 34 mg
Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
Pimavanserin 20 mg
Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth
Placebo
Placebo, taken as two tablets, once daily by mouth
Eligibility Criteria
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Inclusion Criteria
2. Can understand the nature of the trial and protocol requirements and provide signed informed consent
* from patient, if deemed competent to provide consent
* from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
3. Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines
4. Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines
5. Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient). Subjects must have been at their current location for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.
6. Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
7. Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence , for at least 1 month prior to randomization, during the study, and 1 month following completion of the study
8. The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests
Exclusion Criteria
2. Patient is receiving skilled nursing care for any medical condition other than dementia
3. Treatment with an antipsychotic medication within 2 weeks of Baseline visit or 5 half lives, whichever is longer
4. Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
5. Has had a myocardial infarction within the last six months
6. Has a history or symptoms of long QT syndrome
7. Has a history of a significant psychotic disorder before or during the diagnosis of probable Alzheimer's disease (including, but not limited to schizophrenia or bipolar disorder)
8. Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures 9. Has a sensitivity to pimavanserin or its excipients
10\. Has previously participated in a clinical study with pimavanserin
11\. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior within the last 3 months at Screening or since last visit at Baseline
50 Years
ALL
No
Sponsors
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ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Costa Mesa, California, United States
Fresno, California, United States
Fullerton, California, United States
Los Angeles, California, United States
Pasadena, California, United States
San Diego, California, United States
Danbury, Connecticut, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Deerfield Beach, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Atlanta, Georgia, United States
Bangor, Maine, United States
Quincy, Massachusetts, United States
Clinton Township, Michigan, United States
Flowood, Mississippi, United States
Jackson, Mississippi, United States
Eatontown, New Jersey, United States
Marlton, New Jersey, United States
Toms River, New Jersey, United States
Albuquerque, New Mexico, United States
Charlotte, North Carolina, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Jenkintown, Pennsylvania, United States
Norristown, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
DeSoto, Texas, United States
Salt Lake City, Utah, United States
Spokane, Washington, United States
Valdivia, Los Ríos Region, Chile
Antofagasta, , Chile
Santiago, , Chile
Santiago, , Chile
Toulouse, Cedex 9, France
Paris, , France
Saint-Herblain, , France
Strasbourg, , France
Villeurbanne, , France
Algorta, Vizcaya, Spain
Córdoba, , Spain
Elche, , Spain
Madrid, , Spain
Palma de Mallorca, , Spain
Pamplona, , Spain
Santa Coloma de Gramenet, , Spain
Terrassa, , Spain
Zaragoza, , Spain
Swindon, Wiltshire, United Kingdom
Bath, , United Kingdom
Isleworth, , United Kingdom
Manchester, , United Kingdom
Northampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2016-001127-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACP-103-032
Identifier Type: -
Identifier Source: org_study_id
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