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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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02992132
First Posted: December 14, 2016
Last Update Posted: December 7, 2017
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.
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
December 12, 2016
December 14, 2016
December 7, 2017
November 2016
February 2018   (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
Complete list of historical versions of study NCT02992132 on ClinicalTrials.gov Archive Site
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: Quadruple (Participant, Care Provider, 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.
 
Active, not recruiting
120
February 2018
February 2018   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Chile,   France,   Spain,   United Kingdom,   United States
 
 
NCT02992132
ACP-103-032
2016-001127-32 ( EudraCT Number )
Yes
Not Provided
Plan to Share IPD: No
ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Not Provided
Not Provided
ACADIA Pharmaceuticals Inc.
December 2017

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