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

NCT03044249 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: MP-101-01
• Study Type: interventional
• Target: 81
• Locations: 2 countries
• Sites: 20

Brief Summary

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

Conditions

Psychosis; Dementia; Aggression; Agitation; Alzheimer Dementia

Keywords

Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With 30% Improvement From Baseline in the Neuropsychiatric Inventory (NPI) - Psychosis Subscale or Aggression/Agitation Subscale Score

  The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). An NPI response was defined as at least a 30% improvement from baseline on the NPI Psychosis sub-score (for participants with a psychosis diagnosis (Delusions and Hallucinations)) or the NPI Aggression/Agitation sub-score (for participants with an agitation/aggression diagnosis). The delusions, hallucinations, and aggression/agitation domain scores were added together to form a core total score with score range of 0 to 36. Lower score=less severity. A negative change score from baseline indicates improvement.

  Week 10

Secondary Outcomes (8)

• Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10

  Week 10

• Change From Baseline in NPI Total Score

  Baseline, Week 10

• Change From Baseline in NPI Core Total Score

  Baseline, Week 10

• Number of Participants With NPI Caregiver Distress

  Week 10

• Change From Baseline in NPI Domains - Anxiety

  Baseline, 10 Weeks

Study Arms (2)

MP-101

EXPERIMENTAL

Week 0: Participants received 20 milligrams (mg) MP-101 orally QD (1 x 20-mg caps) and 2 placebo caps. Week 1: Participants received 40 mg MP-101 orally QD (2 x 20-mg caps) and 1 placebo caps. Week 2 through Week 9: Participants received 60 mg MP-101 orally QD (3 x 20-mg caps ).

Drug: MP-101

Placebo

PLACEBO COMPARATOR

Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9.

Drug: Placebo

Interventions

MP-101 DRUG

Capsules

Also known as: LY2979165, LY2812223

MP-101

Placebo DRUG

Capsules

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mediti Pharma Inc.: lead

Study Sites (20)

Dignity Health (St. Joseph Hospital and Medical Center)

Phoenix, Arizona, 85013, United States

Location

Neuro-Therapeutics Inc

Pasadena, California, 91105, United States

Location

Associated Neurologists of Southern CT

Fairfield, Connecticut, 06824, United States

Location

Marcus Neuroscience Institute

Boca Raton, Florida, 33486, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Galiz Research

Miami Springs, Florida, 33166, United States

Location

CNS

Orlando, Florida, 32801, United States

Location

Parkinson's Disease Treatment Center of SW Florida

Port Charlotte, Florida, 33980, United States

Location

Meridien Research Inc

St. Petersburg, Florida, 33709, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

College Park Family Care Neuro

Overland Park, Kansas, 66212, United States

Location

J. Gary Booker, MD, Clinical Trials

Shreveport, Louisiana, 71104, United States

Location

Alzheimer's Research Corporation

Paterson, New Jersey, 08759, United States

Location

Clarity Clinical Research

East Syracuse, New York, 13057, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Neurology Diagnostics Inc

Dayton, Ohio, 45459, United States

Location

SKDS Research Inc.

Newmarket, Ontario, L3Y 5G8, Canada

Location

Montreal Neurological Institute

Montreal, Quebec, H3A 2B4, Canada

Location

Centre de recherche sur le vieillissement du CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1J 3H5, Canada

Location

MeSH Terms

Conditions

Psychotic Disorders; Dementia; Aggression; Psychomotor Agitation; Alzheimer Disease

Interventions

LY2812223

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tauopathies; Neurodegenerative Diseases

Limitations and Caveats

Statistical futility; totality of evidence suggests study unlikely to meet endpoint.

Results Point of Contact

• Title: Chief Executive Officer
• Organization: Mediti Pharma Inc.

ivan.shaw@meditipharma.com

1-514-993-7207

Study Officials

• Mediti Pharma

  Mediti Pharma Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 6, 2017
• Study Start: May 4, 2017
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (17)