En studie för att bedöma effektiviteten och säkerheten för ML-007C-MA för behandling av Alzheimers sjukdomspsykos
En randomiserad, dubbelblind, placebokontrollerad studie för att bedöma effektiviteten och säkerheten för ML-007C-MA för behandling av hallucinationer och villfarelser associerade med Alzheimers sjukdomspsykos
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Clinical Trials Contact Center
- Telefonnummer: +1 650 839 4380
- E-post: ML-007C-MA-ADP@maplightrx.com
Studieorter
-
-
-
Córdoba, Argentina, X5004AOA
- Rekrytering
- Clinical Site
-
-
Buenos Aires F.D.
-
Caba, Buenos Aires F.D., Argentina, C1133AAH
- Rekrytering
- Clinical Site
-
-
Córdoba Province
-
Córdoba, Córdoba Province, Argentina, X5009BIN
- Rekrytering
- Clinical Site
-
-
-
-
Pernik
-
Pernik, Pernik, Bulgarien, 2304
- Rekrytering
- Clinical Site
-
-
Sofia
-
Sofia, Sofia, Bulgarien, 1408
- Rekrytering
- Clinical Site
-
-
-
-
-
Santiago, Chile, 7500710
- Rekrytering
- Clinical Site
-
Santiago, Chile, 7560359
- Rekrytering
- Clinical Site
-
-
Antofagasta
-
Antofagasta, Antofagasta, Chile, 1240000
- Rekrytering
- Clinical Site
-
-
-
-
-
Toulouse, Frankrike, 31059
- Rekrytering
- Clinical Site
-
-
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85004
- Rekrytering
- Clinical Site
-
Scottsdale, Arizona, Förenta staterna, 85253
- Rekrytering
- Clinical Site
-
Tucson, Arizona, Förenta staterna, 85704
- Rekrytering
- Clinical Site
-
-
California
-
Anaheim, California, Förenta staterna, 92805
- Rekrytering
- Clinical Site
-
Long Beach, California, Förenta staterna, 90807
- Rekrytering
- Clinical Site
-
Murrieta, California, Förenta staterna, 92562
- Rekrytering
- Clinical Site
-
Orange, California, Förenta staterna, 92866
- Rekrytering
- Clinical Site
-
San Diego, California, Förenta staterna, 92123
- Rekrytering
- Clinical Site
-
-
Colorado
-
Denver, Colorado, Förenta staterna, 80218
- Rekrytering
- Clinical Site
-
-
Florida
-
Boca Raton, Florida, Förenta staterna, 33428
- Rekrytering
- Clinical Site
-
Deerfield Beach, Florida, Förenta staterna, 33442
- Rekrytering
- Clinical Site
-
Doral, Florida, Förenta staterna, 33122
- Rekrytering
- Clinical Site
-
Homestead, Florida, Förenta staterna, 33033
- Rekrytering
- Clinical Site
-
Miami, Florida, Förenta staterna, 33122
- Rekrytering
- Clinical Site
-
Miami, Florida, Förenta staterna, 33155
- Rekrytering
- Clinical Site
-
Miami, Florida, Förenta staterna, 33186
- Rekrytering
- Clinical Site
-
Miami, Florida, Förenta staterna, 33173
- Rekrytering
- Clinical Site
-
Miami Gardens, Florida, Förenta staterna, 33014
- Rekrytering
- Clinical Site
-
Miami Gardens, Florida, Förenta staterna, 33104
- Rekrytering
- Clinical Site
-
Naples, Florida, Förenta staterna, 34105
- Rekrytering
- Clinical Site
-
Orlando, Florida, Förenta staterna, 32807
- Rekrytering
- Clinical Site
-
Tampa, Florida, Förenta staterna, 33629
- Rekrytering
- Clinical Site
-
West Palm Beach, Florida, Förenta staterna, 33407
- Rekrytering
- Clinical Site
-
-
Georgia
-
Augusta, Georgia, Förenta staterna, 30912
- Rekrytering
- Clinical Site
-
Snellville, Georgia, Förenta staterna, 30078
- Rekrytering
- Clinical Site
-
-
Louisiana
-
Alexandria, Louisiana, Förenta staterna, 71301
- Rekrytering
- Clinical Site
-
-
Nevada
-
Las Vegas, Nevada, Förenta staterna, 89121
- Rekrytering
- Clinical Site
-
-
New Jersey
-
West Long Branch, New Jersey, Förenta staterna, 07764
- Rekrytering
- Clinical Site
-
-
New York
-
New York, New York, Förenta staterna, 10003
- Rekrytering
- Clinical Site
-
-
Ohio
-
Dayton, Ohio, Förenta staterna, 45459
- Rekrytering
- Clinical Site
-
Independence, Ohio, Förenta staterna, 44131
- Rekrytering
- Clinical Site
-
-
Oregon
-
Tigard, Oregon, Förenta staterna, 97223
- Rekrytering
- Clinical Site
-
-
South Carolina
-
Port Royal, South Carolina, Förenta staterna, 29935
- Rekrytering
- Clinical Site
-
-
Texas
-
Austin, Texas, Förenta staterna, 78757
- Rekrytering
- Clinical Site
-
McKinney, Texas, Förenta staterna, 75071
- Rekrytering
- Clinical Site
-
Sugarland, Texas, Förenta staterna, 77478
- Rekrytering
- Clinical Site
-
-
Washington
-
Bellevue, Washington, Förenta staterna, 98007
- Rekrytering
- Clinical Site
-
-
-
-
-
Roma, Italien, 00128
- Rekrytering
- Clinical Site
-
-
-
-
Ontario
-
Brampton, Ontario, Kanada, L6W 2Z8
- Har inte rekryterat ännu
- Clinical Site
-
London, Ontario, Kanada, N6A 5W9
- Rekrytering
- Clinical Site
-
Toronto, Ontario, Kanada, M4N 3M5
- Rekrytering
- Clinical Site
-
-
Quebec
-
Lévis, Quebec, Kanada, G6V 0C9
- Rekrytering
- Clinical Site
-
-
-
-
-
Plewiska, Polen, 62-064
- Rekrytering
- Clinical Site
-
-
-
-
Lisbon District
-
Torres Vedras, Lisbon District, Portugal, 2560-280
- Rekrytering
- Clinical Site
-
-
-
-
-
Bucharest, Rumänien, 041914
- Rekrytering
- Clinical Site
-
-
-
-
-
Kragujevac, Serbien, 34000
- Rekrytering
- Clinical Site
-
-
-
-
-
Vranov nad Topľou, Slovakien, 093 01
- Rekrytering
- Clinical Site
-
-
-
-
-
Daegu, Sydkorea, 41404
- Rekrytering
- Clinical Site
-
Incheon, Sydkorea, 21565
- Rekrytering
- Clinical Site
-
-
-
-
-
Choceň, Tjeckien, 565 01
- Rekrytering
- Clinical Site
-
Prague, Tjeckien, 150 00
- Rekrytering
- Clinical Site
-
-
-
-
-
Pécs, Ungern, 7623
- Rekrytering
- Clinical Site
-
Pécs, Ungern, 7633
- Rekrytering
- Clinical Site
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Key Inclusion Criteria:
-
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.
-
Meets clinical criteria for Possible AD or Probable AD.
-
Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.
-
Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.
-
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.
-
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.
-
Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
-
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo
|
Placebo Tablets |
|
Experimentell: ML-007C-MA
|
ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score
Tidsram: 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)
|
|
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
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: MapLight Therapeutics, MapLight Therapeutics
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- Sjukdomar i nervsystemet
- Demens
- Alzheimers sjukdom
- Sjukdomar i centrala nervsystemet
- Neurodegenerativa sjukdomar
- Mentala störningar
- Psykotiska störningar
- Vanföreställningar
- Hjärnsjukdomar
- Hallucinationer
- Neurokognitiva störningar
- Schizofrenispektrum och andra psykotiska störningar
- Muskariniska antagonister
- Tauopatier
- Kolinerga medel
- Muskarin agonister
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Beteendesymtom
- Neurobehavioral manifestationer
- Perceptuella störningar
- Patologiska tillstånd, tecken och symtom
- Beteende
- Tecken och symtom
- Psykotiska störningar
- Alzheimers sjukdom
- Mentala störningar
- Demens
- Hjärnsjukdomar
- Sjukdomar i nervsystemet
- Neurodegenerativa sjukdomar
- Sjukdomar i centrala nervsystemet
- Neurokognitiva störningar
- Hallucinationer
- Schizofrenispektrum och andra psykotiska störningar
- Tauopatier
- Vanföreställningar
Andra studie-ID-nummer
- ML-007C-MA-221
- 2024-519820-26-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .