Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)

Phase 2

Terminated

• Conditions: Agitation and Aggression in Alzheimer's Disease
• Interventions: Drug: Pimavanserin 34 mg; Drug: Pimavanserin 20 mg; Other: Placebo

• Registration Number: NCT02992132
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-14
• Primary Completion: 2018-01-25
• Study Completion: 2018-02-16
• Results First Submitted: 2019-01-25
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-07
• Last Update Submitted: 2019-03-07
• Results First Posted: 2019-03-28
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 111

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

9. Has previously participated in a clinical study with pimavanserin

10. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pimavanserin 34 mg	Pimavanserin 34 mg	Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth
Pimavanserin 20 mg	Pimavanserin 20 mg	Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth
Placebo	Placebo	Placebo, taken as two tablets, once daily by mouth

Primary Outcome Measures

Name	Time	Method
Cohen-Mansfield Agitation Inventory (CMAI)	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

Name	Time	Method
Zarit Burden Interview	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.