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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by ACADIA Pharmaceuticals Inc.
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT02992132
First received: December 12, 2016
Last updated: December 13, 2016
Last verified: December 2016
  Purpose
To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 432
Study Start Date: November 2016
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 50 years of age or older
  2. Must be able to understand and provide signed informed consent

    • from patient, if capable of giving consent
    • from patient's Legally Authorized Representative (LAR) if patient is not capable of giving 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 facility (but can 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. Treatment with an antipsychotic medication within 2 weeks of Baseline visit or 5 half lives, whichever is longer
  3. Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
  4. Has had a myocardial infarction within the last six months
  5. Has a history or symptoms of long QT syndrome
  6. 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)
  7. 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 Has a sensitivity to pimavanserin or its excipients
  8. Has previously participated in a clinical study with pimavanserin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02992132

Contacts
Contact: James M. Youakim, MD 858-261-2981 jyouakim@acadia-pharm.com
Contact: J. Patrick Kesslak 858-320-8699 pkesslak@acadia-pharm.com

Locations
United States, California
Recruiting
Costa Mesa, California, United States, 92626
Recruiting
Fresno, California, United States, 93710
Recruiting
Fullerton, California, United States, 92835
Recruiting
Pasadena, California, United States, 91105
Recruiting
San Diego, California, United States, 92103
United States, Connecticut
Recruiting
Danbury, Connecticut, United States, 06810
United States, Florida
Recruiting
Naples, Florida, United States, 34102
United States, Michigan
Recruiting
Clinton Township, Michigan, United States, 48035
United States, Mississippi
Recruiting
Madison, Mississippi, United States, 39110
United States, New Jersey
Recruiting
Eatontown, New Jersey, United States, 07724
Recruiting
Toms River, New Jersey, United States, 08755
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States, 28270
United States, Texas
Recruiting
Desoto, Texas, United States, 75115
United States, Washington
Recruiting
Spokane, Washington, United States, 99202
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  More Information

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02992132     History of Changes
Other Study ID Numbers: ACP-103-032  2016-001127-32 
Study First Received: December 12, 2016
Last Updated: December 13, 2016
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on February 27, 2017