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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 : Terminated
First Posted : December 14, 2016
Results First Posted : March 28, 2019
Last Update Posted : March 28, 2019
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

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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: 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 Outcome Measures :
  1. Zarit Burden Interview [ Time Frame: 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.

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

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Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  Study Documents (Full-Text)

Documents provided by ACADIA Pharmaceuticals Inc.:
Statistical Analysis Plan  [PDF] November 22, 2017
Study Protocol  [PDF] December 28, 2017

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Responsible Party: ACADIA Pharmaceuticals Inc. Identifier: NCT02992132    
Other Study ID Numbers: ACP-103-032
2016-001127-32 ( EudraCT Number )
First Posted: December 14, 2016    Key Record Dates
Results First Posted: March 28, 2019
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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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
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 Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action