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Trial record 27 of 4496 for:    Recruiting, Not yet recruiting, Available Studies | "Psychotic Disorders"

A Study of MP-101 in the Treatment of Psychosis in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03044249
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : January 12, 2018
Information provided by (Responsible Party):
Mediti Pharma Inc.

Brief Summary:
A ten-week study to assess MP-101 in the treatment of psychosis in participants with Alzheimer's Disease, as compared to placebo.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 Psychosis in Patients With Alzheimer's Disease
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

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

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

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

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

  4. Change from Baseline in NPI Domains [ Time Frame: Baseline up to 10 weeks ]
    Change from baseline in NPI domains of anxiety and agitation/aggression

  5. Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline up to 10 weeks ]
    Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily living inventory (ADCS-ADL)

  6. Change from Baseline in Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: Baseline up to 10 weeks ]
    Change from baseline in Cohen-Mansfield Agitation Inventory (CMAI)

  7. 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

  8. 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

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

Information from the National Library of Medicine

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

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 a documented diagnosis of probable Alzheimer's Disease (AD)
  • Able to communicate verbally
  • Have psychotic symptoms that developed following the diagnosis of probable AD, including visual and/or auditory hallucinations, and/or delusions
  • Have an NPI score of ≥4 on either individual item (delusions or hallucinations) or ≥6 on the Psychosis Subscale (combined delusions and hallucinations)
  • Have an Mini-Mental State Examination (MMSE) score of 10 to 24.
  • Have had an Magnetic Resonance Imaging (MRI) or a computed tomography (CT) scan concurrent with or following the diagnosis of probable AD, to exclude prior stroke or structural brain disease
  • Have a reliable caregiver/study informant 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/study informant must be able to communicate with site personnel, and opinion of the investigator, must understand the written protocol-specified questionnaires. If a caregiver/study informant cannot continue, a replacement caregiver will be allowed if the above criterion is met
  • Are receiving acetylcholinesterase inhibitors (AChEIs) on stable doses ≥3 months prior to or during the study, or in the opinion of the investigator will be likely to remain on a stable treatment regimen for 6 months. Patients not being treated with AChEIs are also eligible for study enrollment
  • 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/study informants)

Exclusion Criteria:

  • Have a history of significant psychotic disorders prior to or simultaneous with the probable diagnosis of AD (including, but not limited to, schizophrenia and bipolar affective disorder)
  • Meet National Institute of Neurological Disorders and Stroke/Association International pour la Recherche et l'Enseignement en Neurosciences criteria for vascular dementia
  • Have an MRI or CT scan (on file since the onset of symptoms of AD) that is inconsistent with a probable diagnosis of AD
  • Meet Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V) criteria for delirium.
  • 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 psychosis from non-AD-associated etiologies (for example, substance abuse or a diagnosis of psychosis prior to the development of AD)
  • 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
  • Use any antipsychotics or any other drug intended to treat psychosis during the study. If the patient is taking the medication prior to study entry, there must be a washout period
  • 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

Contact: Study Director 317-651-7036 Mediti@Choruspharma.com

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.
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: January 12, 2018
Last Verified: January 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
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders