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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

December 12, 2016
December 13, 2016
November 2016
June 2019   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)
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
To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Agitation and Aggression in Alzheimer's Disease
  • Drug: Pimavanserin 34 mg
    Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
  • Drug: Pimavanserin 20 mg
    Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth
  • Other: Placebo
    Placebo, taken as two tablets, once daily by mouth
  • Experimental: Pimavanserin 34 mg
    Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth
    Intervention: Drug: Pimavanserin 34 mg
  • Experimental: Pimavanserin 20 mg
    Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth
    Intervention: Drug: Pimavanserin 20 mg
  • Placebo Comparator: Placebo
    Placebo, taken as two tablets, once daily by mouth
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
432
Not Provided
June 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact: James M. Youakim, MD 858-261-2981 jyouakim@acadia-pharm.com
Contact: J. Patrick Kesslak 858-320-8699 pkesslak@acadia-pharm.com
United States
 
 
NCT02992132
ACP-103-032
2016-001127-32 ( EudraCT Number )
Yes
Not Provided
No
Not Provided
ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Not Provided
Not Provided
ACADIA Pharmaceuticals Inc.
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP