Een onderzoek om de werkzaamheid en veiligheid van ML-007C-MA te beoordelen voor de behandeling van de psychose van Alzheimer
Een gerandomiseerde, dubbelblinde, placebo-gecontroleerd onderzoek om de werkzaamheid en veiligheid van ML-007C-MA te beoordelen voor de behandeling van hallucinaties en wanen geassocieerd met de ziekte van Alzheimer
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Clinical Trials Contact Center
- Telefoonnummer: +1 650 839 4380
- E-mail: ML-007C-MA-ADP@maplightrx.com
Studie Locaties
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Córdoba, Argentinië, X5004AOA
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Buenos Aires F.D.
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Caba, Buenos Aires F.D., Argentinië, C1133AAH
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Córdoba Province
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Córdoba, Córdoba Province, Argentinië, X5009BIN
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Pernik
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Pernik, Pernik, Bulgarije, 2304
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Sofia
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Sofia, Sofia, Bulgarije, 1408
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Ontario
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Brampton, Ontario, Canada, L6W 2Z8
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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, Chili, 7500710
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Santiago, Chili, 7560359
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Antofagasta
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Antofagasta, Antofagasta, Chili, 1240000
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Toulouse, Frankrijk, 31059
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Pécs, Hongarije, 7623
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Pécs, Hongarije, 7633
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Roma, Italië, 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, Roemenië, 041914
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Kragujevac, Servië, 34000
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Vranov nad Topľou, Slowakije, 093 01
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Choceň, Tsjechië, 565 01
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Prague, Tsjechië, 150 00
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85004
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Scottsdale, Arizona, Verenigde Staten, 85253
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Tucson, Arizona, Verenigde Staten, 85704
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California
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Anaheim, California, Verenigde Staten, 92805
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Long Beach, California, Verenigde Staten, 90807
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Murrieta, California, Verenigde Staten, 92562
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Orange, California, Verenigde Staten, 92866
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San Diego, California, Verenigde Staten, 92123
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Colorado
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Denver, Colorado, Verenigde Staten, 80218
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Florida
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Boca Raton, Florida, Verenigde Staten, 33428
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Deerfield Beach, Florida, Verenigde Staten, 33442
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Doral, Florida, Verenigde Staten, 33122
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Homestead, Florida, Verenigde Staten, 33033
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Miami, Florida, Verenigde Staten, 33122
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Miami, Florida, Verenigde Staten, 33155
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Miami, Florida, Verenigde Staten, 33186
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Miami, Florida, Verenigde Staten, 33173
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Miami Gardens, Florida, Verenigde Staten, 33014
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Miami Gardens, Florida, Verenigde Staten, 33104
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Naples, Florida, Verenigde Staten, 34105
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Orlando, Florida, Verenigde Staten, 32807
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Tampa, Florida, Verenigde Staten, 33629
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West Palm Beach, Florida, Verenigde Staten, 33407
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Georgia
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Augusta, Georgia, Verenigde Staten, 30912
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Snellville, Georgia, Verenigde Staten, 30078
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Louisiana
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Alexandria, Louisiana, Verenigde Staten, 71301
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89121
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New Jersey
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West Long Branch, New Jersey, Verenigde Staten, 07764
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New York
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New York, New York, Verenigde Staten, 10003
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Ohio
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Dayton, Ohio, Verenigde Staten, 45459
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Independence, Ohio, Verenigde Staten, 44131
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Oregon
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Tigard, Oregon, Verenigde Staten, 97223
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South Carolina
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Port Royal, South Carolina, Verenigde Staten, 29935
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Texas
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Austin, Texas, Verenigde Staten, 78757
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McKinney, Texas, Verenigde Staten, 75071
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Sugarland, Texas, Verenigde Staten, 77478
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Washington
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Bellevue, Washington, Verenigde Staten, 98007
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Daegu, Zuid -Korea, 41404
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Incheon, Zuid -Korea, 21565
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo
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Placebo Tablets |
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Experimenteel: ML-007C-MA
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ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score
Tijdsspanne: Baseline and End of Treatment (7 weeks)
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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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score
Tijdsspanne: Baseline and End of Treatment (7 weeks)
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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
Tijdsspanne: Baseline and End of Treatment (7 weeks)
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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)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: MapLight Therapeutics, MapLight Therapeutics
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- Ziekten van het zenuwstelsel
- Dementie
- Ziekte van Alzheimer
- Ziekten van het centrale zenuwstelsel
- Neurodegeneratieve ziekten
- Psychische aandoening
- Psychotische stoornissen
- Waanideeën
- Hersenziekten
- Hallucinaties
- Neurocognitieve stoornissen
- Schizofreniespectrum en andere psychotische stoornissen
- Muscarine-antagonisten
- Tauopathieën
- Cholinerge middelen
- Muscarinische agonisten
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Gedragssymptomen
- Neurologische gedragsmanifestaties
- Perceptuele stoornissen
- Pathologische aandoeningen, tekenen en symptomen
- Gedrag
- Tekenen en symptomen
- Psychotische stoornissen
- Ziekte van Alzheimer
- Psychische aandoening
- Dementie
- Hersenziekten
- Ziekten van het zenuwstelsel
- Neurodegeneratieve ziekten
- Ziekten van het centrale zenuwstelsel
- Neurocognitieve stoornissen
- Hallucinaties
- Schizofreniespectrum en andere psychotische stoornissen
- Tauopathieën
- Waanideeën
Andere studie-ID-nummers
- ML-007C-MA-221
- 2024-519820-26-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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