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

NCT ID: NCT03044249

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-04
• Study Completion Date: 2020-01-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MP-101

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 ).

Group Type: EXPERIMENTAL

MP-101

Intervention Type: DRUG

Capsules

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsules

Interventions

MP-101

Capsules

Intervention Type: DRUG

Placebo

Capsules

Intervention Type: DRUG

Other Intervention Names

LY2979165; LY2812223

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mediti Pharma Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mediti Pharma

Role: STUDY_DIRECTOR

Mediti Pharma Inc.

Locations

Dignity Health (St. Joseph Hospital and Medical Center)

Phoenix, Arizona, United States

Neuro-Therapeutics Inc

Pasadena, California, United States

Associated Neurologists of Southern CT

Fairfield, Connecticut, United States

Marcus Neuroscience Institute

Boca Raton, Florida, United States

Meridien Research

Brooksville, Florida, United States

Galiz Research

Hialeah, Florida, United States

Galiz Research

Miami Springs, Florida, United States

CNS

Orlando, Florida, United States

Parkinson's Disease Treatment Center of SW Florida

Port Charlotte, Florida, United States

Meridien Research Inc

St. Petersburg, Florida, United States

University of South Florida

Tampa, Florida, United States

College Park Family Care Neuro

Overland Park, Kansas, United States

J. Gary Booker, MD, Clinical Trials

Shreveport, Louisiana, United States

Alzheimer's Research Corporation

Paterson, New Jersey, United States

Clarity Clinical Research

East Syracuse, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Neurology Diagnostics Inc

Dayton, Ohio, United States

SKDS Research Inc.

Newmarket, Ontario, Canada

Montreal Neurological Institute

Montreal, Quebec, Canada

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

Sherbrooke, Quebec, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MP-101-01

Identifier Type: -

Identifier Source: org_study_id