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A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression

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ClinicalTrials.gov Identifier: NCT03044249
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Mediti Pharma Inc.

Brief Summary:
A ten-week study to assess MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression

Condition or disease Intervention/treatment Phase
Psychosis Dementia Aggression Agitation Alzheimer Dementia Drug: MP-101 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Tolerability, Pharmacokinetics, and Efficacy of MP-101 in the Treatment of Patients With Dementia-Related Psychosis and/or Agitation and Aggression
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: MP-101
Escalating dose administered orally once daily, starting at 20 milligrams up to 60 milligrams
Drug: MP-101
Capsules
Other Names:
  • LY2979165
  • LY2812223

Placebo Comparator: Placebo
Administered orally once daily
Drug: Placebo
Capsules




Primary Outcome Measures :
  1. Change from baseline in the Neuropsychiatric Inventory (NPI) - Psychosis subscale [ Time Frame: Baseline up to 10 weeks ]
    Change from baseline in the Neuropsychiatric Inventory (NPI) psychosis subscale that covers delusions and hallucinations, and/or in the agitation/aggression domain


Secondary Outcome Measures :
  1. Change from baseline in the Clinical Global Impression of Improvement (CGI-I) [ Time Frame: Baseline up to ten weeks ]
    Change from baseline in the Clinical Global Impression of Improvement (CGI-I)

  2. Change from Baseline in NPI Total Score [ Time Frame: Baseline up to 10 weeks ]
    Change from baseline in NPI total score

  3. Change from Baseline in NPI Core Total Score [ Time Frame: Baseline up to 10 weeks ]
    Combination of 3 items: hallucinations, delusions, and agitation/aggression

  4. Change from Baseline in NPI Caregiver Distress [ Time Frame: Baseline up to 10 weeks ]
    Change from baseline in NPI caregiver distress

  5. Change from Baseline in NPI Domains [ Time Frame: Baseline up to 10 weeks ]
    Change from baseline in NPI domains of anxiety

  6. Number of Participants with any Treatment Emergent Adverse Event [ Time Frame: Baseline up to 11 weeks ]
    Number of participants with untoward medical occurrences that emerge during the treatment period, having been absent pretreatment, or worsen relative to the pretreatment state, which do not necessarily have a causal relationship with this treatment

  7. Change from Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III [ Time Frame: Baseline up to 10 weeks ]
    Change from baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) part III

  8. Population Pharmacokinetics: Plasma Levels of MP-101 and Metabolite [ Time Frame: Baseline up to 10 weeks ]
    Parameters from weeks 2, 4, 6, 8 or 10, combined utilizing a population approach



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females must be of non-childbearing potential, defined as women greater than or equal to (≥) 60 years of age, postmenopausal women ≥50 and less than(<) 60 years of age who have had a cessation of menses for at least 12 months, or women who are congenitally or surgically sterile
  • Males must agree to use 2 forms of highly effective birth control with female partners of childbearing potential while enrolled in the study, and for at least 28 days following the last dose
  • Ambulatory (with or without walking device) with a stable gait
  • Have an Mini-Mental State Examination (MMSE) score of 10 to 24
  • Meet clinical criteria for one of the following disorders: dementia associated with Parkinson's disease, dementia with Lewy bodies, possible or probable Alzheimer's disease, frontotemporal degeneration spectrum disorders, vascular dementia
  • Able to communicate verbally
  • Have an NPI score of ≥4 on either individual item (delusions or hallucinations) or ≥6 on the Psychosis Subscale (combined delusions and hallucinations), or an NPI score of ≥4 on agitation/aggression domain
  • Have a reliable caregiver who provides written informed consent to participate and who is in frequent contact with the patient (defined as spending at least 4 hours/day at least 4 days/week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors). The caregiver must be able to communicate with site personnel, and opinion of the investigator, must understand the written protocol-specified questionnaires. If a caregiver cannot continue, one replacement caregiver will be allowed if the above criterion is met
  • Must be on a stable dose of cholinesterase inhibitor and/or memantine, if applicable
  • If taking antipsychotic drugs or any drug intended to treat psychosis, must be on a stable treatment regimen for ≥1 month prior to the study
  • Have venous access sufficient to allow for blood sampling per the protocol
  • Have clinical laboratory test results within normal reference range for the population or investigative site
  • Are capable of participating in all study assessments
  • Are able and willing to provide consent (patients and caregivers)

Exclusion Criteria:

  • Have a history of significant psychotic disorders (including, schizophrenia, delusional disorder, substance abuse psychosis that lasted over 6 months, major depressive disorder or bipolar disorder with psychotic episodes)
  • Has a history of ischemic stroke within the last 12 months or any evidence of hemorrhagic stroke
  • Have renal impairment as defined by Estimated Glomerular Filtration Rate (eGFR) <45 milliliters per minute per 1.73 square meters (ml/min/1.73m2)
  • Have significant cardiovascular, respiratory, gastrointestinal, renal, hematologic, or oncologic comorbidities that could impact patient safety and study participation over 10 weeks
  • Have a history of seizures or other condition that would place the patient at increased risk of seizures.
  • Are, in the investigator's judgment, at risk for suicide, or as indicated by the Columbia Suicide Severity Rating Scale (C-SSRS)
  • Have a Fridericia's corrected QT interval (QTcF) greater than (>) 450 milliseconds (ms) for males or 470 ms for females
  • Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, at least 3 months (or more) must have passed
  • In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

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): NCT03044249


Contacts
Contact: Study Director choruspharma@lists.lilly.com

Locations
United States, Florida
Meridien Research Recruiting
Brooksville, Florida, United States, 34601
Contact: James Andersen    352-597-8839    jandersen@meridienresearch.net   
Principal Investigator: James Andersen         
Galiz Research Recruiting
Hialeah, Florida, United States, 33016
Contact: Jose Gamez    305-805-0921    jegamez@galizresearch.com   
Principal Investigator: Jose Gamez         
Galiz Research Recruiting
Miami Springs, Florida, United States, 33166
Contact: Jose Gamez    305-820-3381    jegamez@galizresearch.com   
Principal Investigator: Jose Gamez         
Parkinson's Disease Treatment Center of SW Florida Recruiting
Port Charlotte, Florida, United States, 33980
Contact: Ramon Gil    941-743-4987    dawnm@ParkinsonsFL.com   
Principal Investigator: Ramon Gill, MD         
Meridien Research Inc Recruiting
Saint Petersburg, Florida, United States, 33709
Contact: Gigi Lefebvre    727-347-8839    glefebvre@meridienresearch.net   
Principal Investigator: Gigi Lefebvre         
United States, Louisiana
J. Gary Booker, MD, Clinical Trials Recruiting
Shreveport, Louisiana, United States, 71104
Contact: J G Booker    318-227-9600    drjgarybooker@bellsouth.net   
Principal Investigator: J G Booker, MD         
United States, New Jersey
Alzheimer's Research Corporation Recruiting
Manchester, New Jersey, United States, 08759
Contact: Joshua Shua Haim    732-657-6100    shua-haim@comcast.net   
Principal Investigator: Joshua Shua Haim         
United States, New York
Richmond Behavioral Associates Recruiting
Staten Island, New York, United States, 10312
Contact: Mark DiBuono    718-317-5522 ext 3    dibuono@rbany.com   
Principal Investigator: Mark DiBuono         
Canada, Ontario
SKDS Research Inc. Recruiting
Newmarket, Ontario, Canada, L3Y 5G8
Contact: Sam Henein    905-898-7582      
Principal Investigator: Sam Henein, MD         
Sponsors and Collaborators
Mediti Pharma Inc.
Investigators
Study Director: Mediti Pharma Mediti Pharma Inc.

Responsible Party: Mediti Pharma Inc.
ClinicalTrials.gov Identifier: NCT03044249     History of Changes
Other Study ID Numbers: MP-101-01
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mediti Pharma Inc.:
Psychotic Disorders

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Dementia
Alzheimer Disease
Psychomotor Agitation
Aggression
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Tauopathies
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Behavioral Symptoms