Clinical trial NCT02992132: Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Agitation and Aggression in Alzheimer's Disease
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-14
Enrollment: 111
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Zarit Burden Interview
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Costa Mesa
country: United States
state: California
city: Fresno
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Diego
country: United States
state: California
city: Danbury
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Boca Raton
country: United States
state: Florida
city: Deerfield Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Bangor
country: United States
state: Maine
city: Quincy
country: United States
state: Massachusetts
city: Clinton Township
country: United States
state: Michigan
city: Flowood
country: United States
state: Mississippi
city: Jackson
country: United States
state: Mississippi
city: Eatontown
country: United States
state: New Jersey
city: Marlton
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Charlotte
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Jenkintown
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Willow Grove
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: DeSoto
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Spokane
country: United States
state: Washington
city: Valdivia
country: Chile
state: Los Rios
city: Antofagasta
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Toulouse
country: France
state: Cedex 9
city: Paris
country: France
city: Saint-Herblain
country: France
city: Strasbourg
country: France
city: Villeurbanne
country: France
city: Algorta
country: Spain
state: Vizcaya
city: Córdoba
country: Spain
city: Elche
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Pamplona
country: Spain
city: Santa Coloma De Gramenet
country: Spain
city: Terrassa
country: Spain
city: Zaragoza
country: Spain
city: Swindon
country: United Kingdom
state: Wiltshire
city: Bath
country: United Kingdom
city: Isleworth
country: United Kingdom
city: Manchester
country: United Kingdom
city: Northampton
country: United Kingdom
Study officials:
References: