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Completed

NCT Number: NCT03118947

A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease

To evaluate the safety and tolerability of pimavanserin over 52 weeks of treatment in subjects with probable AD who have symptoms of agitation and aggression

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Key information

Conditions

Agitation and Aggression in Alzheimer's Disease Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Psicomed Estudios Médicos, Antofagasta, Chile

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug
  • 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.
  • Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient)
  • Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
  • Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence, during the study, and 1 month following completion of the study
  • The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests

Exclusion criteria

  • Patient was significantly non-compliant in Study ACP-103-032
  • The Investigator becomes aware of an impending and unexpected change in the patient's living situation (e.g., change in caregiver, change in facility, moving from home to facility, moving from one family member or caregiver's home to another) that may cause a major disruption in the patient's behavior
  • Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
  • 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 clinically significant laboratory abnormalities that would jeopardize the safe participation of the patient in the study
  • Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior since the last assessment

Treatment and study plan

Pimavanserin

Drug

Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth

Primary outcomes

  1. Treatment Emergent Adverse Events (TEAEs)

    Time frame: 52 weeks

    Safety and tolerability of pimavanserin after 52 weeks of treatment in patients with probable Alzheimer's disease who have symptoms of agitation and Aggression, in terms of occurrence of TEAEs

Sponsors and collaborators

Lead sponsor

ACADIA Pharmaceuticals Inc.

Industry

Registry information

Official study title

A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2017
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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