TerminatedPhase 2Results posted

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

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

Lead sponsor

Mediti Pharma Inc.

Asset

MP-101

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, Frontotemporal dementia, Lewy body dementia, Vascular cognitive impairment / dementia

Key I/E criteria

•Multiple dementia etiologies•MMSE 10-24•Study partner/caregiver required•AD symptomatic therapy: stable

Primary endpoint

•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDMP-101-01

NCT IDNCT03044249

Timeline

Milestones

Study first posted2017-02-06estimated

Study start2017-05-04actual

Primary completion2020-01-30actual

Study completion2020-01-30actual

Last update posted2021-04-01actual

Results first posted2021-04-01actual

Assets

Drug assets

MP-101

Study populations

Who this study enrolls

Alzheimer’s diseaseFrontotemporal dementiaLewy body dementiaVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Safety / tolerability / PK

Other clinical outcomes

Other (unclassified)

Behavior / neuropsychiatric

10 endpoints

Primary/protocol endpoint

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

Time frame:Week 10

Neuropsychiatric Inventory (NPI)

threshold achievement, improvement

Primary/registry result

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

Time frame:Week 10

Neuropsychiatric Inventory (NPI)

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	Reported bounds
Placebon=33 Participants	58	-
MP-101n=26 Participants	62	-

Response Ratio490% CI-18 - 25p0.48Fisher Exact

Secondary/protocol endpoint

Change From Baseline in NPI Total Score

Time frame:Baseline, Week 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI Core Total Score

Time frame:Baseline, Week 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants With NPI Caregiver Distress

Time frame:Week 10

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Change From Baseline in NPI Domains - Anxiety

Time frame:Baseline, 10 Weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in NPI Total Score

Time frame:Baseline, Week 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebon=34 Participants	-3.43	2.34
MP-101n=26 Participants	-8.70	2.66

Mean Difference (Final Values)-5.2890% CI-11.16 - 0.61p0.14Mixed Models Analysis

Secondary/registry result

Change From Baseline in NPI Core Total Score

Time frame:Baseline, Week 10

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebon=34 Participants	-3.46	1.15
MP-101n=26 Participants	-5.05	1.31

Mean Difference (Final Values)-1.5890% CI-4.47 - 1.31p0.37Mixed Models Analysis

Secondary/registry result

Number of Participants With NPI Caregiver Distress

Time frame:Week 10

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PlaceboWeek 10 Delusions ( Not at all)n=34 Participants	0	-
Week 10 Delusions ( Minimally)n=34 Participants	1	-
Week 10 Delusions (Mildly)n=34 Participants	9	-
Week 10 Delusions (Moderately)n=34 Participants	7	-
Week 10 Delusions (severely)n=34 Participants	1	-
Week 10 Delusions (Very Severely or extremely)n=34 Participants	1	-
Week 10 Hallucinations ( Not at all)n=34 Participants	3	-
Week 10 Hallucinations ( Minimally)n=34 Participants	3	-
Week 10 Hallucinations (Mildly)n=34 Participants	3	-
Week 10 Hallucinations (Moderately)n=34 Participants	6	-
Week 10 Hallucinations (severely)n=34 Participants	1	-
Week 10 Hallucinations (Very Severely or extremely)n=34 Participants	0	-
MP-101Week 10 Delusions ( Not at all)n=26 Participants	0	-
Week 10 Delusions ( Minimally)n=26 Participants	1	-
Week 10 Delusions (Mildly)n=26 Participants	5	-
Week 10 Delusions (Moderately)n=26 Participants	3	-
Week 10 Delusions (severely)n=26 Participants	2	-
Week 10 Delusions (Very Severely or extremely)n=26 Participants	0	-
Week 10 Hallucinations ( Not at all)n=26 Participants	1	-
Week 10 Hallucinations ( Minimally)n=26 Participants	3	-
Week 10 Hallucinations (Mildly)n=26 Participants	4	-
Week 10 Hallucinations (Moderately)n=26 Participants	2	-
Week 10 Hallucinations (severely)n=26 Participants	1	-
Week 10 Hallucinations (Very Severely or extremely)n=26 Participants	0	-

Secondary/registry result

Change From Baseline in NPI Domains - Anxiety

Time frame:Baseline, 10 Weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Placebon=32 Participants	-0.1	3.53
MP-101n=25 Participants	-0.6	2.69

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Number of Participants With Any Treatment Emergent Adverse Event

Time frame:Baseline Up to 10 Weeks

event count, event

Secondary/protocol endpoint

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

Time frame: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

concentration, descriptive

Secondary/registry result

Number of Participants With Any Treatment Emergent Adverse Event

Time frame:Baseline Up to 10 Weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebon=42 Participants	24	-
MP-101n=39 Participants	24	-

Secondary/registry result

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

Time frame: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

concentration, descriptive

Posted result

Group	Value (geometric_mean), Nanomoles per liter (nmol/L)	Geometric coefficient of variation
MP-101Week 2: 4-8 hoursn=17 Participants	7.9	1.11
Week 4: 0-2 hoursn=14 Participants	11.4	1.09
Week 6: 8-12 hoursn=11 Participants	4.1	1.36
Week 10: 2- 4 hoursn=16 Participants	9.3	1.12
Early Terminationn=1 Participants	NA	NA
LY2812223 (MP-101 Metabolite)Week 2: 4-8 hoursn=25 Participants	429.8	1.00
Week 4: Predosen=22 Participants	85.0	1.01
Week 4: 0-2 hoursn=25 Participants	249	1.01
Week 6: 8-12 hoursn=22 Participants	808.4	1.00
Week 10: 2- 4 hoursn=20 Participants	929	1.00
Early Terminationn=4 Participants	13.0	1.24

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

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

Time frame:Week 10

threshold achievement, improvement

Secondary/registry result

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

Time frame:Week 10

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	Reported bounds
PlaceboVery much improvedn=32 Participants	0	-
Much improvedn=32 Participants	25.0	-
Minimally improvedn=32 Participants	34.4	-
No changen=32 Participants	21.9	-
Minimally worsen=32 Participants	15.6	-
Much worsen=32 Participants	3.1	-
Very much worsen=32 Participants	0	-
MP-101Very much improvedn=25 Participants	8.0	-
Much improvedn=25 Participants	28.0	-
Minimally improvedn=25 Participants	28.0	-
No changen=25 Participants	16.0	-
Minimally worsen=25 Participants	12.0	-
Much worsen=25 Participants	8.0	-
Very much worsen=25 Participants	0	-

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, Week 10

change from baseline, improvement

Secondary/registry result/low confidence

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

Time frame:Baseline, Week 10

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
Placebon=34 Participants	-0.29	0.76
MP-101n=26 Participants	-0.37	0.87

Mean Difference (Final Values)-0.0890% CI-2.00 - 1.84p0.94Mixed Models Analysis

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.