Clinical trial NCT03044249: A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression
Official title: Tolerability, Pharmacokinetics, and Efficacy of MP-101 in the Treatment of Patients With Dementia-Related Psychosis and/or Agitation and Aggression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psychosis
Dementia
Aggression
Agitation
Alzheimer Dementia
Keywords: Psychotic Disorders
Lead sponsor: Mediti Pharma Inc.
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 81
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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 a 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

Primary outcomes:
measure: Percentage of Participants With 30% Improvement From Baseline in the Neuropsychiatric Inventory (NPI) - Psychosis Subscale or Aggression/Agitation Subscale Score
timeFrame: Week 10
Secondary outcomes:
measure: Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10
timeFrame: Week 10
measure: Change From Baseline in NPI Total Score
timeFrame: Baseline, Week 10
measure: Change From Baseline in NPI Core Total Score
timeFrame: Baseline, Week 10
measure: Number of Participants With NPI Caregiver Distress
timeFrame: Week 10
measure: Change From Baseline in NPI Domains - Anxiety
timeFrame: Baseline, 10 Weeks
measure: Number of Participants With Any Treatment Emergent Adverse Event
timeFrame: Baseline Up to 10 Weeks
measure: Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III
timeFrame: Baseline, Week 10
measure: Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite
timeFrame: Week 2: 4-8 hours post-dose; Week 4: Predose, 0-2 hours postdose; Week 6: 8-12 hours postdose; Week 10: 2- 4 hours;Early Termination
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dignity Health (St. Joseph Hospital and Medical Center)
state: Arizona
city: Pasadena
country: United States
facility: Neuro-Therapeutics Inc
state: California
city: Fairfield
country: United States
facility: Associated Neurologists of Southern CT
state: Connecticut
city: Boca Raton
country: United States
facility: Marcus Neuroscience Institute
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Miami Springs
country: United States
facility: Galiz Research
state: Florida
city: Orlando
country: United States
facility: CNS
state: Florida
city: Port Charlotte
country: United States
facility: Parkinson's Disease Treatment Center of SW Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research Inc
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Overland Park
country: United States
facility: College Park Family Care Neuro
state: Kansas
city: Shreveport
country: United States
facility: J. Gary Booker, MD, Clinical Trials
state: Louisiana
city: Manchester
country: United States
facility: Alzheimer's Research Corporation
state: New Jersey
city: East Syracuse
country: United States
facility: Clarity Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Dayton
country: United States
facility: Neurology Diagnostics Inc
state: Ohio
city: Newmarket
country: Canada
facility: SKDS Research Inc.
state: Ontario
city: Montréal
country: Canada
facility: Montreal Neurological Institute
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement du CIUSSS de l'Estrie - CHUS
state: Quebec
Study officials:
affiliation: Mediti Pharma Inc.
name: Mediti Pharma
role: STUDY_DIRECTOR
References: