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PsychosisPhase 2NCT03044249

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

A Phase 2 study testing MP-101 in people with Psychosis and Dementia, run by Mediti Pharma Inc. at 20 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 50 years and older
Conditions the study is for
Psychosis, Dementia, Aggression
What is being tested?
MP-101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
20 sitesin 2 countries
Study dates
4 May 2017to 30 Jan 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

United States17 sites

  • Marcus Neuroscience Institute

    Boca Raton, Florida, 33486

  • Meridien Research

    Brooksville, Florida, 34601

  • Neurology Diagnostics Inc

    Dayton, Ohio, 45459

  • Clarity Clinical Research

    East Syracuse, New York, 13057

  • Associated Neurologists of Southern CT

    Fairfield, Connecticut, 06824

  • Galiz Research

    Hialeah, Florida, 33016

  • Galiz Research

    Miami Springs, Florida, 33166

  • CNS

    Orlando, Florida, 32801

  • College Park Family Care Neuro

    Overland Park, Kansas, 66212

  • Neuro-Therapeutics Inc

    Pasadena, California, 91105

  • Alzheimer's Research Corporation

    Paterson, New Jersey, 08759

  • Dignity Health (St. Joseph Hospital and Medical Center)

    Phoenix, Arizona, 85013

  • Parkinson's Disease Treatment Center of SW Florida

    Port Charlotte, Florida, 33980

  • J. Gary Booker, MD, Clinical Trials

    Shreveport, Louisiana, 71104

  • Meridien Research Inc

    St. Petersburg, Florida, 33709

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • University of South Florida

    Tampa, Florida, 33613

Other trials in United States

Canada3 sites

  • Montreal Neurological Institute

    Montreal, Quebec, H3A 2B4

  • SKDS Research Inc.

    Newmarket, Ontario, L3Y 5G8

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

    Sherbrooke, Quebec, J1J 3H5

Other trials in Canada

About this study

Official title: Tolerability, Pharmacokinetics, and Efficacy of MP-101 in the Treatment of Patients With Dementia-Related Psychosis and/or Agitation and Aggression

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

Being tested
MP-101, Placebo
Keywords
Psychotic Disorders
Medical subject headings
Psychotic Disorders, Dementia, Aggression, Psychomotor Agitation, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MP-101Drug

    Also called LY2979165, LY2812223

    Capsules

  • PlaceboDrug

    Capsules

Study groups in NCT03044249
Study groupRoleWhat they receive
MP-101ExperimentalWeek 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 ).
Receives: Drug: MP-101
PlaceboPlacebo comparatorParticipants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 10

Secondary outcomes (8)

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

    The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

    Measured: Week 10

  2. Change From Baseline in NPI Total 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). The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.

    Measured: Baseline, Week 10

  3. Change From Baseline in NPI Core Total Score

    The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral 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). The NPI CoreTotal Score is calculated by adding the Individual Item Scores for all 3 domains (hallucinations, delusions, and agitation/aggression) to yield a possible NPI Core Total Score of 0 to 36. Lower score=less severity. A negative change score from baseline indicates improvement.

    Measured: Baseline, Week 10

  4. Number of Participants With NPI Caregiver Distress

    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). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement.

    Measured: Week 10

  5. Change From Baseline in NPI Domains - Anxiety

    The 12 individual items in NPI that quantify changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each of 12 behavioral 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). The NPI Psychosis Subscale Anxiety consists of anxiety item to yield a possible NPI Score of 0 to 12. Lower score=less severity. A negative change score from baseline indicates improvement.

    Measured: Baseline, 10 Weeks

  6. Number of Participants With Any Treatment Emergent Adverse Event

    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. A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs) is located in the reported adverse events module.

    Measured: Baseline Up to 10 Weeks

  7. Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III

    Part III of the UPDRS is an investigator-scored scale used to assess the motor symptoms of patients with Parkinson's disease. The investigator rates the patient on 14 items based on observation or the performance of a task the patient performs (even in the context of any comorbidities) on a 5-point scale. The scores range from 0 to 4, with higher scores indicating greater impairment. The total UPDRS score was calculated as the sum of all items, ranging from 0 to 56 with higher scores indicating greater impairment. If any individual item was missing, the UPDRS score was be set to missing.

    Measured: Baseline, Week 10

  8. Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite

    Summary statistics of sparse blood concentration samples at weeks 2, 4, 6, 10 and Early Termination obtained utilizing a population PK approach.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2017 (estimated)
  2. Study start4 May 2017
  3. Primary completion30 Jan 2020
  4. Study completion30 Jan 2020

Why it stopped: Statistical futility; totality of evidence suggests study unlikely to meet endpoint

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03044249
Sponsor's protocol ID
MP-101-01
Status last verified
Mar 2021
First submitted
31 Jan 2017
Last updated
1 Apr 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MP-101 in people with Psychosis and Dementia, run by Mediti Pharma Inc. at 20 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With 30% Improvement From Baseline in the Neuropsychiatric Inventory (NPI) - Psychosis Subscale or Aggression/Agitation Subscale Score (time frame: Week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03044249.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.

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