Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02992132
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : March 19, 2018
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment

Condition or disease Intervention/treatment Phase
Agitation and Aggression in Alzheimer's Disease Drug: Pimavanserin 34 mg Drug: Pimavanserin 20 mg Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease
Study Start Date : November 2016
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : February 16, 2018

Arm Intervention/treatment
Experimental: Pimavanserin 34 mg
Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth
Drug: Pimavanserin 34 mg
Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth

Experimental: Pimavanserin 20 mg
Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth
Drug: Pimavanserin 20 mg
Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth

Placebo Comparator: Placebo
Placebo, taken as two tablets, once daily by mouth
Other: Placebo
Placebo, taken as two tablets, once daily by mouth

Primary Outcome Measures :
  1. Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: Approximately 12 weeks ]
    Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score

Information from the National Library of Medicine

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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:

  1. Male or female, 50 years of age or older
  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:

  1. The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
  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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02992132

  Hide Study Locations
United States, California
Costa Mesa, California, United States, 92626
Fresno, California, United States, 93710
Fullerton, California, United States, 92835
Los Angeles, California, United States, 90073
Pasadena, California, United States, 91105
San Diego, California, United States, 92103
United States, Connecticut
Danbury, Connecticut, United States, 06810
United States, District of Columbia
Washington, District of Columbia, United States, 20057
United States, Florida
Boca Raton, Florida, United States, 33486
Deerfield Beach, Florida, United States, 33064
Miami, Florida, United States, 33137
Naples, Florida, United States, 34102
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Maine
Bangor, Maine, United States, 04401
United States, Massachusetts
Quincy, Massachusetts, United States, 02169
United States, Michigan
Clinton Township, Michigan, United States, 48035
United States, Mississippi
Flowood, Mississippi, United States, 39232
Jackson, Mississippi, United States, 39216
United States, New Jersey
Eatontown, New Jersey, United States, 07724
Marlton, New Jersey, United States, 08053
Toms River, New Jersey, United States, 08755
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Charlotte, North Carolina, United States, 28270
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Medford, Oregon, United States, 97504
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
Norristown, Pennsylvania, United States, 19401
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Charleston, South Carolina, United States, 29401
United States, Tennessee
Nashville, Tennessee, United States, 37212
United States, Texas
DeSoto, Texas, United States, 75115
United States, Utah
Salt Lake City, Utah, United States, 84107
United States, Washington
Spokane, Washington, United States, 99202
Valdivia, Los Rios, Chile, 5090000
Antofagasta, Chile, 1270244
Santiago, Chile, 7500710
Santiago, Chile, 7560356
Toulouse, Cedex 9, France, 31059
Paris, France, 75010
Saint-Herblain, France, 44800
Strasbourg, France, 67200
Villeurbanne, France, 69100
Algorta, Viscaya, Spain, 48993
Córdoba, Spain, 14011
Elche, Spain, 03203
Madrid, Spain, 28044
Palma de Mallorca, Spain, 07010
Pamplona, Spain, 31014
Santa Coloma De Gramenet, Spain, 08921
Terrassa, Spain, 08221
Zaragoza, Spain, 50012
United Kingdom
Swindon, Wiltshire, United Kingdom, SN3 6BW
Bath, United Kingdom, BA1 3NG
Isleworth, United Kingdom, TW7 6AF
Manchester, United Kingdom, M21 9UN
Northampton, United Kingdom, NN5 6UD
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

Responsible Party: ACADIA Pharmaceuticals Inc. Identifier: NCT02992132     History of Changes
Other Study ID Numbers: ACP-103-032
2016-001127-32 ( EudraCT Number )
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Behavioral Symptoms
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action