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A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575052
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
The purpose of this study is to assess the safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease.

Condition or disease Intervention/treatment Phase
Neuropsychiatric Symptoms Related to Neurodegenerative Disease Drug: Pimavanserin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Safety Study of Pimavanserin Therapy in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug - Pimavanserin Drug: Pimavanserin
Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)

Placebo Comparator: Placebo Drug: Placebo
Placebo, tablets, once daily by mouth (provided as two placebo tablets)




Primary Outcome Measures :
  1. Treatment-emergent adverse events (TEAEs) [ Time Frame: Treatment Period: 8 weeks ]
    Safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease


Secondary Outcome Measures :
  1. Change from Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) [ Time Frame: Treatment Period: 8 weeks ]
  2. Change from Baseline to Week 8 in Mini-Mental State Examination (MMSE) [ Time Frame: Treatment Period: 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Can understand the nature of the trial and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:

    1. The subject's legally acceptable representative (LAR) (or study partner/caregiver, if local regulations allow) must provide written informed consent
    2. The subject must provide written (if capable) informed assent
  2. Subject requires some or complete assistance with one or more of the following:

    1. Instrumental activities of daily living (communication, transportation, meal preparation, shopping, housework, managing medications, managing personal finances) OR
    2. Basic activities of daily living (personal hygiene, dressing, eating, maintaining continence or transferring)
  3. Meets clinical criteria for at least one of the following disorders, with or without cerebrovascular disease (CVD):

    1. Parkinson's disease with or without dementia as defined by the Movement Disorder Society's Task Force
    2. Dementia with Lewy bodies (DLB)
    3. All-cause dementia, possible or probable Alzheimer's disease (AD)
    4. Frontotemporal degeneration spectrum disorders, including possible or probable:

    i. Behavioral variant frontotemporal dementia

    ii. Progressive supranuclear palsy

    iii. Corticobasal degeneration

    e. Vascular dementia, including post-stroke dementia multi-infarct dementia and/or subcortical ischemic vascular dementia (SIVD)

  4. Has a designated study partner/caregiver
  5. Can come to the clinic for study visits with a study partner/caregiver
  6. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception or be abstinent.
  7. If the subject is taking an antipsychotic medication at the time of screening, the antipsychotic medication must be discontinued 2 weeks or 5 half-lives (whichever is longer)

Exclusion Criteria:

  1. Is in hospice, is receiving end-of-life palliative care, or is bedridden
  2. Has psychotic symptoms that are primarily attributable to delirium or substance abuse (i.e., neuropsychiatric symptoms not related to neurodegenerative disease)
  3. Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
  4. Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
  5. Has a clinical significant CNS abnormality that is most likely contributing to the dementia or findings on MRI or CT including:

    1. intracranial mass lesion
    2. vascular malformation
    3. evidence of >4 hemosiderin deposits
  6. The urine drug screen result at Visit 1 (Screening) indicates the presence of amphetamine/methamphetamine, barbiturates, cocaine, or phencyclidine (PCP). Subjects who test positive for amphetamines and who have a valid prescription may be retested if they agree to abstain from the medication for the length of their participation in the study. The presence of benzodiazepines, marijuana (THC), or opiates does not necessarily exclude the subject from the study, as assessed by the Investigator in consultation with the Medical Monitor.
  7. Has previously been enrolled in any prior clinical study with pimavanserin or is currently taking pimavanserinIs judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575052


Contacts
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Contact: Brian Raether 858-768-6074 braether@acadia-pharm.com
Contact: Jason Do 858-261-2971 jdo@acadia-pharm.com

Locations
Show Show 80 study locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03575052    
Other Study ID Numbers: ACP-103-046
2017-003536-36 ( EudraCT Number )
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurodegenerative Diseases
Nervous System Diseases
Pimavanserin
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action