En undersøgelse til vurdering af effektiviteten og sikkerheden af ML-007C-MA til behandling af Alzheimers sygdomspsykose
En randomiseret, dobbeltblind, placebokontrolleret undersøgelse for at vurdere effektiviteten og sikkerheden af ML-007C-MA til behandling af hallucinationer og vrangforestillinger forbundet med Alzheimers sygdomspsykose
ML-007C-MA-221 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ML-007C-MA in male and female participants aged 55 to 90 years with hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP).
The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions associated with ADP as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Clinical Trials Contact Center
- Telefonnummer: +1 650 839 4380
- E-mail: ML-007C-MA-ADP@maplightrx.com
Studiesteder
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Córdoba, Argentina, X5004AOA
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Buenos Aires F.D.
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Caba, Buenos Aires F.D., Argentina, C1133AAH
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Córdoba Province
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Córdoba, Córdoba Province, Argentina, X5009BIN
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Pernik
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Pernik, Pernik, Bulgarien, 2304
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Sofia
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Sofia, Sofia, Bulgarien, 1408
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Ontario
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Brampton, Ontario, Canada, L6W 2Z8
- Ikke rekrutterer endnu
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London, Ontario, Canada, N6A 5W9
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Toronto, Ontario, Canada, M4N 3M5
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Quebec
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Lévis, Quebec, Canada, G6V 0C9
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Santiago, Chile, 7500710
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Santiago, Chile, 7560359
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Antofagasta
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Antofagasta, Antofagasta, Chile, 1240000
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Arizona
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Phoenix, Arizona, Forenede Stater, 85004
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Scottsdale, Arizona, Forenede Stater, 85253
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Tucson, Arizona, Forenede Stater, 85704
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California
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Anaheim, California, Forenede Stater, 92805
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Long Beach, California, Forenede Stater, 90807
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Murrieta, California, Forenede Stater, 92562
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Orange, California, Forenede Stater, 92866
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San Diego, California, Forenede Stater, 92123
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Colorado
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Denver, Colorado, Forenede Stater, 80218
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Florida
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Boca Raton, Florida, Forenede Stater, 33428
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Deerfield Beach, Florida, Forenede Stater, 33442
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Doral, Florida, Forenede Stater, 33122
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Homestead, Florida, Forenede Stater, 33033
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Miami, Florida, Forenede Stater, 33122
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Miami, Florida, Forenede Stater, 33155
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Miami, Florida, Forenede Stater, 33186
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Miami, Florida, Forenede Stater, 33173
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Miami Gardens, Florida, Forenede Stater, 33014
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Miami Gardens, Florida, Forenede Stater, 33104
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Naples, Florida, Forenede Stater, 34105
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Orlando, Florida, Forenede Stater, 32807
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Tampa, Florida, Forenede Stater, 33629
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West Palm Beach, Florida, Forenede Stater, 33407
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Georgia
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Augusta, Georgia, Forenede Stater, 30912
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Snellville, Georgia, Forenede Stater, 30078
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Louisiana
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Alexandria, Louisiana, Forenede Stater, 71301
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89121
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New Jersey
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West Long Branch, New Jersey, Forenede Stater, 07764
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New York
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New York, New York, Forenede Stater, 10003
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Ohio
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Dayton, Ohio, Forenede Stater, 45459
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Independence, Ohio, Forenede Stater, 44131
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Oregon
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Tigard, Oregon, Forenede Stater, 97223
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South Carolina
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Port Royal, South Carolina, Forenede Stater, 29935
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Texas
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Austin, Texas, Forenede Stater, 78757
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McKinney, Texas, Forenede Stater, 75071
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Sugarland, Texas, Forenede Stater, 77478
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Washington
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Bellevue, Washington, Forenede Stater, 98007
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Toulouse, Frankrig, 31059
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Roma, Italien, 00128
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Plewiska, Polen, 62-064
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Lisbon District
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Torres Vedras, Lisbon District, Portugal, 2560-280
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Bucharest, Rumænien, 041914
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Kragujevac, Serbien, 34000
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Vranov nad Topľou, Slovakiet, 093 01
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Daegu, Sydkorea, 41404
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Incheon, Sydkorea, 21565
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Choceň, Tjekkiet, 565 01
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Prague, Tjekkiet, 150 00
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Pécs, Ungarn, 7623
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Pécs, Ungarn, 7633
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Key Inclusion Criteria:
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Willing and able to provide written informed consent, or, if deemed lacking in the capacity to provide informed consent, the following requirements for consent must be met:
- The participant's LAR must provide written informed consent AND
- The participant will provide informed assent.
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Meets clinical criteria for Possible AD or Probable AD.
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Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.
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Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.
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Has a designated care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug.
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Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria:
- Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR
- Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items.
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Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
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Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive.
Key Exclusion Criteria:
- Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
- Psychotic symptoms that are primarily attributable to substance abuse or a medical, neurological or psychiatric condition other than Alzheimer's disease.
- Evidence of a CNS disorder other than Alzheimer's disease that is the primary cause of, or a significant contributor to the participant's dementia.
- Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria.
- Has an elevated risk of suicidal behavior
- Has had an amyloid PET brain scan or CSF Alzheimer's disease biomarker test in the past 3 years with results inconsistent with a diagnosis of AD.
- Evidence of a clinically significant and/or unstable medical condition that, in the opinion of the investigator or medical monitor, could substantially impair cognition, compromise participant safety, interfere with the participant's ability to comply with study procedures or substantially impair the evaluation of efficacy or safety assessments.
- Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma
- Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).
- Has previously participated in any clinical study with ML-007 or ML-007C-MA.
- Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients.
- Received or may have received an investigational drug, biological product or device within 90 days before Baseline (or 6 months for investigational Alzheimer's disease-modifying therapies).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Placebo
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Placebo Tablets |
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Eksperimentel: ML-007C-MA
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ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score
Tidsramme: Baseline and End of Treatment (7 weeks)
|
NPI-C H+D scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes. |
Baseline and End of Treatment (7 weeks)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score
Tidsramme: Baseline and End of Treatment (7 weeks)
|
The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the participant's hallucinations and delusions using the investigator's judgment and past experience with participants who have Alzheimer's disease psychosis. Higher scores on this scale indicate worse outcomes. |
Baseline and End of Treatment (7 weeks)
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Change from Baseline to End of Treatment in the Neuropsychiatric Inventory - Clinician Agitation and Aggression (NPI-C A+A) score in participants who have a CGI-S agitation/aggression domain-specific score of ≥4 at Baseline
Tidsramme: Baseline and End of Treatment (7 weeks)
|
NPI-C A+A scale includes 2 domains from the NPI-C scale, namely, agitation and aggression. These 2 domains include the following number of items to be rated by the clinician: Agitation, 13 items (maximum score = 39), and Aggression, 8 items (maximum score = 24). The maximum score for the NPI-C A+A scale is 63. Higher scores on this scale indicate more severe symptoms of agitation and aggression. |
Baseline and End of Treatment (7 weeks)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: MapLight Therapeutics, MapLight Therapeutics
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Sygdomme i nervesystemet
- Demens
- Alzheimers sygdom
- Sygdomme i centralnervesystemet
- Neurodegenerative sygdomme
- Psykiske lidelser
- Psykotiske lidelser
- Vrangforestillinger
- Hjernesygdomme
- Hallucinationer
- Neurokognitive lidelser
- Skizofrenispektrum og andre psykotiske lidelser
- Muskarine antagonister
- Tauopatier
- Kolinerge midler
- Muscariniske agonister
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Adfærdsmæssige symptomer
- Neuroadfærdsmæssige manifestationer
- Perceptuelle forstyrrelser
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Tegn og symptomer
- Psykotiske lidelser
- Alzheimers sygdom
- Psykiske lidelser
- Demens
- Hjernesygdomme
- Sygdomme i nervesystemet
- Neurodegenerative sygdomme
- Sygdomme i centralnervesystemet
- Neurokognitive lidelser
- Hallucinationer
- Skizofrenispektrum og andre psykotiske lidelser
- Tauopatier
- Vrangforestillinger
Andre undersøgelses-id-numre
- ML-007C-MA-221
- 2024-519820-26-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
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