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

Acadia Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Agitation and Aggression in Alzheimer's Disease

Treatments: Other: Placebo; Drug: Pimavanserin 34 mg; Drug: Pimavanserin 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02992132

ACP-103-032

2016-001127-32 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 111 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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111 participants in 3 patient groups, including a placebo group

Pimavanserin 34 mg

Experimental group

Description:

Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth

Treatment:

Drug: Pimavanserin 34 mg

Pimavanserin 20 mg

Experimental group

Description:

Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth

Treatment:

Drug: Pimavanserin 20 mg

Placebo

Placebo Comparator group

Description:

Placebo, taken as two tablets, once daily by mouth

Treatment:

Other: Placebo