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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521710-25-00 | EU Trial (CTIS) Number |
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Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
Study Website: https://illumerastudy.com/
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACP-204 30 mg | Experimental | ACP-204 dose of 30 mg once daily |
|
| ACP-204 60 mg | Experimental | ACP-204 dose of 60 mg once daily |
|
| Placebo | Placebo Comparator | Placebo once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACP-204 | Drug | Provided as 1 capsule, to be taken orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in SAPS-LBDP total score at Week 6 | Change from Baseline in Scale for the Assessment of Positive Symptoms- Lewy Body Dementia Psychosis (SAPS-LBDP) total score at Week 6 | 6 weeks |
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Inclusion Criteria:
Male or female ≥55 years to <85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting
Can provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:
Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium).
Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin Kidd | Contact | 434-841-3162 | Kristin.kidd@acadia-pharm.com | |
| Becky Howell | Contact | 848-702-1886 | bhowell@acadia-pharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATP Clinical Research Inc. | Recruiting | Irvine | California | 92612 | United States | |
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Subjects will be randomized to one of 3 parallel arms i.e. ACP-204 at one of 2 dose levels (30 or 60 mg) or placebo
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| Placebo | Drug | Provided as 1 capsule, to be taken orally once daily |
|
| Georgetown University |
| Recruiting |
| Washington D.C. |
| District of Columbia |
| 20057 |
| United States |
| Humanity Clinical Research, Corp | Recruiting | Aventura | Florida | 33180 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Recruiting | Boca Raton | Florida | 33486 | United States |
| K2 Medical Research Winter Garden LLC | Recruiting | Clermont | Florida | 34711 | United States |
| University of Florida - Shands | Recruiting | Gainesville | Florida | 32608 | United States |
| K2 Summit Research | Recruiting | Lady Lake | Florida | 32159 | United States |
| Neurology Associates, P. A. | Recruiting | Maitland | Florida | 32751 | United States |
| Homestead Associates in Research Inc | Recruiting | Miami | Florida | 33032 | United States |
| Premier Clinical Research Institute, Inc. | Recruiting | Miami | Florida | 33122 | United States |
| Advanced Clinical Research Network, Corp | Recruiting | Miami | Florida | 33135 | United States |
| MediClear Medical & Research Center, Inc. | Recruiting | Miami | Florida | 33165 | United States |
| Health Synergy Clinical Research, LLC | Recruiting | West Palm Beach | Florida | 33407 | United States |
| Hawaii Pacific Neuroscience | Recruiting | Honolulu | Hawaii | 96817 | United States |
| University of Kansas Medical Center Research Institute Inc. | Recruiting | Kansas City | Kansas | 66160 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long Island | Recruiting | Commack | New York | 11725 | United States |
| UNC Hospitals | Recruiting | Chapel Hill | North Carolina | 27517 | United States |
| The Ohio State University, Energy Advancement and Innovation Center | Recruiting | Columbus | Ohio | 43210 | United States |
| The Movement Disorder Clinic of Oklahoma | Recruiting | Tulsa | Oklahoma | 74136 | United States |
| Abington Neurological Associates, LTD | Suspended | Abington | Pennsylvania | 19001 | United States |
| Horizon Clinical Research Group | Recruiting | Cypress | Texas | 77429 | United States |
| Prolato Clinical Research Center | Recruiting | Houston | Texas | 77054 | United States |
| The University of Texas Health Science Center San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
| R and H Clinical Research | Recruiting | Stafford | Texas | 77477 | United States |
| Virginia Commonwealth University (a public institution of higher education) | Recruiting | Richmond | Virginia | 23219 | United States |
| EvergreenHealth | Recruiting | Kirkland | Washington | 98034 | United States |
| Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov | Recruiting | Cherven Bryag | 5980 | Bulgaria |
| UMHAT Sv Georgi EAD | Recruiting | Plovdiv | 4002 | Bulgaria |
| Medical Center SV.Naum | Recruiting | Sofia | 1113 | Bulgaria |
| DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD | Recruiting | Sofia | 1408 | Bulgaria |
| UMHAT "Alexandrovska" EAD | Recruiting | Sofia | 1431 | Bulgaria |
| Medical Center Detsko Zdrave Branch Maestro Kanev | Recruiting | Sofia | 1618 | Bulgaria |
| DCC Mladost M- Varna, OOD | Recruiting | Varna | 9000 | Bulgaria |
| Fakultni nemocnice u sv. Anny v Brne | Recruiting | Brno | 656 91 | Czechia |
| NEUROHK s.r.o. Poliklinika Chocen a.s. | Recruiting | Choceň | 56501 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Recruiting | Prague | 12808 | Czechia |
| Neuropsychiatrie s.r.o. | Recruiting | Prague | 16000 | Czechia |
| Vestra Clinics s.r.o | Recruiting | Rychnov nad Kněžnou | 51601 | Czechia |
| CHU de Toulouse- Hopital Purpan | Recruiting | Toulouse | Cedex 9 | 31059 | France |
| Gérontopôle Centre de Recherche Clinique | Recruiting | Toulouse | Cedex 9 | 31059 | France |
| Hopital Roger Salengro - CHU Lille | Recruiting | Lille | Nord | 59037 | France |
| Hôpital Lariboisière, Histologie et CMRR | Recruiting | Paris | Paris | 75010 | France |
| Hôpital des Chapennes | Recruiting | Villeurbanne | Rhone | 69100 | France |
| Hopital Neurologique Bron | Recruiting | Bron | 69677 | France |
| Hopital BROCA | Recruiting | Paris | 75013 | France |
| CHU Strasbourg-Hopital Hautepierre | Recruiting | Strasbourg | 67000 | France |
| CHRU de Tours- Hopital Bretonneau | Recruiting | Tours | 37044 | France |
| CHRU de Nancy- Hospital de Brabois | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
| Azienda Ospedaliera Univerrsitaria | Recruiting | Naples | Napoli | 80138 | Italy |
| Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona | Recruiting | Salerno | Salerno | 84131 | Italy |
| Azieda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
| Università Campus Bio-Medico di Roma | Recruiting | Roma | 128 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia | Recruiting | Roma | 185 | Italy |
| Institute of Mental Health | Recruiting | Belgrade | 11000 | Serbia |
| University Clinical Center of Serbia | Recruiting | Belgrade | 11000 | Serbia |
| University Clinical Hospital Center Zvezdara | Recruiting | Belgrade | 11000 | Serbia |
| University Clinical Center Kragujevac | Recruiting | Kragujevac | 34000 | Serbia |