Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
1,074
Countries
5
Sites
46
Alzheimer Disease psychosis
Study will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo.
Key facts
- Sponsor
- Acadia Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 2 Jul 2024 → ongoing
- Decision date (initial)
- 2024-06-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Acadia Pharmaceuticals Inc.
External identifiers
- EU CT number
- 2023-507325-42-00
- ClinicalTrials.gov
- NCT06159673
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Pharmacodynamic, Dose response, Efficacy
Study will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo.
Conditions and MedDRA coding
Alzheimer Disease psychosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012271 | Dementia Alzheimer's type | 100000004852 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Part 1 (Phase 2) Subjects may be enrolled into only one part of the study. No subject may be enrolled into more than one of Part 1, Part 2A, and Part 2B.
In Part 1, approximately 318 subjects will be randomized in a 1:1:1 ratio to ACP-204 60 mg, ACP-204 30 mg, or placebo. At least 100 evaluable subjects will be randomized per treatment group.
Each substudy individually will consist of a screening period (up to 42 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
Subjects who complete Part 1 will have the option of participating in the long-term OLE study.
|
Randomised Controlled | Double | [{"id":185612,"code":1,"name":"Subject"},{"id":185611,"code":5,"name":"Carer"},{"id":185610,"code":2,"name":"Investigator"},{"id":185609,"code":3,"name":"Monitor"}] | ACP-204 60mg - Administration once daily at approximately the same time of day, with or without food: ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A. ACP-204 30mg - Administration once daily at approximately the same time of day, with or without food: ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A. Placebo - Administration once daily at approximately the same time of day, with or without food: ACP-204 matching placebo |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 11
- Is male or female and ≥55 and <85 years of age living in the community or in an institutionalized setting
- Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria
- Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)
- Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD
- Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD
- MMSE score ≥6 and ≤24
- Psychotic symptoms for at least 2 months
- Lives in a stable place of residence and there are no plans to change living arrangements
- Has a designated study partner/caregiver
- Able to complete all study visits with a study partner/caregiver
- Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable
Exclusion criteria 9
- Requires treatment with a medication prohibited by the protocol
- Is in hospice and receiving end-of-life palliative care, or has become bedridden
- Requires skilled nursing care
- Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia
- Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope
- Atrial fibrillation
- Symptomatic orthostatic hypotension
- Protocol-defined exclusionary clinical laboratory findings
- Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- From baseline to Week 6: 1. Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline.
Secondary endpoints 1
- From baseline to Week 6: Clinical Global Impression–Severity in the ADP context (CGI-S-ADP) total score change from baseline
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11086730 · Product
- Active substance
- ACP-204 Tartrate
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 2520 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ACADIA PHARMACEUTICALS
- Paediatric formulation
- No
- Orphan designation
- No
PRD11086728 · Product
- Active substance
- ACP-204 Tartrate
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 2520 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ACADIA PHARMACEUTICALS
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Acadia Pharmaceuticals Inc.
- Sponsor organisation
- Acadia Pharmaceuticals Inc.
- Address
- 12830 El Camino Real Suite 400
- City
- San Diego
- Postcode
- 92130-2976
- Country
- United States
Scientific contact point
- Organisation
- Acadia Pharmaceuticals Inc.
- Contact name
- Bryan Dirks, Vice President, Clinical Development Lead for ACP Program
Public contact point
- Organisation
- Acadia Pharmaceuticals Inc.
- Contact name
- Christine Murphy, Senior Clinical Study Manager
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Gray Consulting Inc. ORG-100044159
|
Philadelphia, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other, Code 8 |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Code 13, Code 2, Code 5, Data management, E-data capture, Code 8 |
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Laboratory analysis |
Locations
5 EU/EEA countries · 46 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruitment ended | 82 | 12 |
| Czechia | Ongoing, recruitment ended | 66 | 8 |
| France | Ongoing, recruiting | 52 | 12 |
| Italy | Ongoing, recruiting | 62 | 10 |
| Spain | Ongoing, recruitment ended | 20 | 4 |
| Rest of world
Mexico, Chile, Brazil, Taiwan, Korea, Republic of, Serbia, United States
|
— | 792 | — |
Investigational sites
Medical Center Spectar Plovdiv EOOD
N/A, Ulitsa Makedoniya 107, 4004, Plovdiv
Higya–DCC OOD
N/A, Ulitsa Sveti Ivan Rilski 3, 4400, Pazardzhik
Medical Center Hera EOOD
N/A, Ulitsa Klisura 20, 1510, Sofiya
Alexandrovska University Hospital
Clinic of Psychiatry, Georgy Sofiiski Str 1, 1431, Sofia
Medical Center Intermedica Ltd.
N/A, Belite Brezim, Ulitsa Nishava 62, Sofiya
Center For Mental Health Prof. N. Shipkovenski EOOD
N/A, Ulitsa Ekzarh Yosif 59, 1000, Sofia
Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET
N/A, Ulitsa Yane Sandanski 61, 5980, Cherven Bryag
Medical Center Lifemed EOOD
N/A, 1st Floor, Ulitsa Ekzarh Yosif 14, Kirdzhali
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
N/A, Ulitsa Dimitir Manov 17, 1408, Sofiya
Medical Center Medconsult Pleven OOD
N/A, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Alexandrovska University Hospital
Clinic of neurological disorders, Georgy Sofiiski Str 1, 1431, Sofia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Psychiatry, Bulevard Vasil Aprilov 15a, 4002, Plovdiv
Forbeli s.r.o.
NA, Kolejni 429/5 Dejvice, 160 00, Prague
INEP medical s.r.o.
NA, Krizikova 264/22, Karlin, Prague
Neurohk s.r.o.
NA, Smetanova 830, 565 01, Chocen
Brain-Soultherapy s.r.o.
NA, K Nemocnici 1904, 272 01, Kladno
Vestra Clinics s.r.o.
NA, Jiraskova 1389, 516 01, Rychnov Nad Kneznou
Ad71 s.r.o.
NA, Sudkova 2a/686, 109 00, Prague
Clintrial s.r.o.
NA, Pocernicka 1427/16, Strasnice, Prague 10
Fakultni Nemocnice U Sv Anny V Brne
I.Neurologická klinika, Pekarska 53, Stare Brno, Brno-Stred
Centre Hospitalier Regional Universitaire De Tours
Centre Mémoire Ressources et Recherche (CMRR), 2 Boulevard Tonnelle, 37000, Tours
Hospital Pierre Wertheimer
Service Neurologie, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Et Universitaire De Limoges
Service de Médecine Gériatrique, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire De Dijon
Centre Mémoire Ressources et Recherche, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon
Centre Hospitalier Universitaire De Toulouse
Gérontopôle Centre de Recherche Clinique, Place Lange, 31059, Toulouse Cedex 9
Hospices Civils De Lyon
Centre de Recherche Clinique, 27 Rue Gabriel Peri, 69100, Villeurbanne
Centre Hospitalier Pasteur
Centre pour Personnes Âgées, 39 Avenue De La Liberte, Bp 60535, Colmar Cedex
Assistance Publique Hopitaux De Paris
Centre de Neurologie Cognitive, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
Centre Hospitalier Universitaire De Toulouse
Service de Neurologie, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Centre Hospitalier Universitaire Rouen
Service de Neurologie, 1 Rue De Germont, 76000, Rouen
Assistance Publique Hopitaux De Paris
Pôle de gériatrie, 54 56 Rue Pascal 54a, 75013, Paris
CHRU De Nancy
Département Gériatrie Aigue, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Neurology, Largo Francesco Vito 1, 00168, Rome
Ospedale San Raffaele S.r.l.
Neurology, Via Olgettina 60, 20132, Milan
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Neurology, Largo Citta' D'ippocrate 1, 84131, Salerno
Universita' Campus Bio-medico Di Roma
Neurology, Via Alvaro Del Portillo 200, 00128, Rome
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Neurology, Via Cherasco 15, 10126, Turin
Pia Fondazione Di Culto E Religione Card G Panico
Neurology, Via Pio X 4, 73039, Tricase
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Neurology, Viale Del Policlinico 155, 00161, Rome
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Neurology, Via Atinense N. 18, 86077, Pozzilli
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Neurology, Piazzale Spedali Civili 1, 25123, Brescia
Fondazione Istituto G. Giglio Di Cafalu
U.O Neurologia, Contrada Pietra Pollastra Snc, 90015, Cefalu'
Complejo Asistencial De Zamora Hospital Provincial De Zamora
Neurology, Calle De Hernan Cortes 40, 49020, Zamora
Hospital Universitario Virgen De La Macarena
Neurology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Germans Trias I Pujol
Neurology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Regional De Malaga
Neurology, Avenida De Carlos De Haya Sn, 29010, Malaga
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2024-07-02 | 2024-07-11 | 2026-05-26 | ||
| Czechia | 2024-07-17 | 2024-08-21 | 2026-05-26 | ||
| France | 2024-07-29 | 2024-09-18 | |||
| Italy | 2024-07-23 | 2024-08-26 | |||
| Spain | 2024-10-10 | 2025-03-03 | 2026-05-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 175 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ACP-204-006 Bulgaria Memo_red-san | NA |
| Protocol (for publication) | D1_Protocol_2023-507325-42-00_redacted | 4-EU v1.0 |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_Italian Italy _v1_san | 1 |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_screenshot_CZEcs_v1_san | CZEcs_v1 |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_screenshots_Bulgarian Bulgaria_v1_san | 1 |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_screenshots_FRAfr_v1_san | FRAfr_v1 |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_Spanish Spain _v1_san | 1 |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_V1_eng_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-MMSE screenshot_v1_eng-san | 1 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_Bulgarian Bulgaria_v1_san | 1.0 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_csy CZE_v1_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_Italian Italy_v1_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_screenshots_FRAfr_v1_san | FRAfr_v1 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_Spanish Spain_v1_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_Stimuli_FRAfr_v1.0_san | FRAfr_v1.0 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_Stimuli_V1_eng-san | 1 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_v1_eng-san | 1 |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1 _Spanish_Spain_ v1_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1_Bulgarian Bulgaria_v1_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1_Czech CZ_san | Czech CZ |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1_eng-san | 1 |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1_FRAfr_v1_san | FRAfr_v1 |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1_Italian Italy_v1_san | 1 |
| Protocol (for publication) | D4_Patient_facing_document_Radiant_Patient ID Card_FRAfr_V01FRAfr_san | V01FRAfr |
| Protocol (for publication) | D4_Patient_facing_document_Radiant_Patient ID Card_V01_eng | 1 |
| Protocol (for publication) | D4_Patient_facing_document_Radiant_Patient ID Card_V01BGR bg_san | V01BGR bg |
| Protocol (for publication) | D4_Patient_facing_document_Radiant_Patient ID Card_V01CZE cs_san | V01CZE cs |
| Protocol (for publication) | D4_Patient_facing_document_Radiant_Patient ID Card_V01ESP es_san | V01ESP es |
| Protocol (for publication) | D4_Patient_facing_document_Radiant_Patient ID Card_V01ITAit_san | V01ITAit |
| Protocol (for publication) | D4_Patient-facing_NPI-C_BG_2023-507325-42-00_clean | 1.0 |
| Protocol (for publication) | D4_Patient-facing_NPI-C_CZ_2023-507325-42-00_clean | 1.0 |
| Protocol (for publication) | D4_Patient-facing_NPI-C_EN_2023-507325-42-00_clean | 1.0 |
| Protocol (for publication) | D4_Patient-facing_NPI-C_ES_2023-507325-42-00_clean | 1.0 |
| Protocol (for publication) | D4_Patient-facing_NPI-C_FR_2023-507325-42-00_clean | 1.0 |
| Protocol (for publication) | D4_Patient-facing_NPI-C_IT_2023-507325-42-00_clean | 1.0 |
| Protocol (for publication) | MTF_Scale_Footers_v1_red-san | 1 |
| Recruitment arrangements (for publication) | 2_7_Recruitment material_Patient and Care Partner Brochure_BGR_san | V01 BGR |
| Recruitment arrangements (for publication) | K0_Cover letter_Bulgaria_RA_Part II_final_san | 1.0 |
| Recruitment arrangements (for publication) | K0_Cover letter_Bulgaria_SM-1_Part II_final_san | 1.0 |
| Recruitment arrangements (for publication) | K1_ACP-204-006_Iconsent_patientrecruitmentprocedure | v3 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF Procedure_san | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG_san | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CLEAN_san | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN_san | 2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment15 Script | 1.0 |
| Recruitment arrangements (for publication) | K2_1_Recruitment material_Dr-to-Patient Letter_BGR_san | 1.0 |
| Recruitment arrangements (for publication) | K2_10_Recruitment material_15 Script_san | 1 |
| Recruitment arrangements (for publication) | K2_11_Recruitment material_30 Script_san | 1 |
| Recruitment arrangements (for publication) | K2_12_Recruitment material_Online Advertising Script_san | 1 |
| Recruitment arrangements (for publication) | K2_13_Recruitment material_Online Screening Script_san | 1 |
| Recruitment arrangements (for publication) | K2_4_Recruitment material_Patient Advocacy Group Letter_BGR_san | 1.0 |
| Recruitment arrangements (for publication) | K2_5_Recruitment material_Patient and Care Partner Flyer_BGR_san | 1.0 |
| Recruitment arrangements (for publication) | K2_8_Recruitment material_Recruiting Brochure_san | 1.0 |
| Recruitment arrangements (for publication) | K2_9_Recruitment material_Advertising Images_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material 15 script | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material 30 script | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Advertising Images | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Advocacy Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Online Advertising Script | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Online Screening Website | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Recruiting Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_15 Script_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_30 Script_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advertising Images_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Letter Script_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Letter_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Online Advertising Script_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Online Screening Script_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient ID Card Script_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Letter Script_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Letter_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Flyer Script_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Radiant_Physician Referral Letter_sa | V01EU(cs) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruiting Brochure Script_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruiting Brochure_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Welcome Brochure Script_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Welcome Letter Script_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_30 Script | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment_Advertising Images | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment_Advocacy Letter Script | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment_Online Advertising Script | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment_Online Screening Script | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment_Patient Letter Script | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment_Print_Flyer_ Script | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment_Recruiting Brochure Script | 1.0 |
| Recruitment arrangements (for publication) | K4_Recruitment Material_ACP-204-006_Patient Advocacy Group Letter | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Caregiver_clean-san | V2.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_1_1_SIS and ICF Main ICF Master_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_1_2_SIS and ICF_Main ICF_EN_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_1_3_SIS and ICF_Main ICF_BG_san | V2.0BGR1.0 |
| Subject information and informed consent form (for publication) | L1_2_1_SIS and ICF Caregiver ICF Master_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_2_2_SIS and ICF Caregiver ICF EN_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_2_3_SIS and ICF Caregiver ICF BG_san | V2.0BGR1.0 |
| Subject information and informed consent form (for publication) | L1_3_1_SIS and ICF PP ICF Master_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_3_2_SIS and ICF PP ICF EN_san | 1.1 |
| Subject information and informed consent form (for publication) | L1_3_3_SIS and ICF PP ICF BG_san | V1.0BGR1.1 |
| Subject information and informed consent form (for publication) | L1_ACP-204-006_ICF_Main ICF | 2.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ACP-204-006_Italy_Pregnant Partner ICF | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_ACP-204-006_Italy_Privacy Information Sheet_clean_san | V1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_already enrolled patient _san | V2.0CZE2.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_san | V2.0CZE2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_clean_san | V2.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_CLEAN_san | V2.0FRA3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Child Data Collection_CLEAN_san | V1.0FRA5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CLEAN_san | V2.0FRA5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Data Collection_CLEAN_san | V1.0FRA4.0 |
| Subject information and informed consent form (for publication) | L2_ eConsaent_Glossary_san | V01 |
| Subject information and informed consent form (for publication) | L2_ eConsaent_Video Storyboard_san | V02 EU(cs) |
| Subject information and informed consent form (for publication) | L2_ Other subject material_Video Storyboard_Clean-san | 02 |
| Subject information and informed consent form (for publication) | L2_1_Other subject Information material_Participant Welcome Letter_BGR_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_10_ESRS-A_Instructions_BGR_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_10_ESRS-A_Long Form_BGR_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_11_SDI_BGR_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_12_NPI-12_BGR_san | AU1.1 |
| Subject information and informed consent form (for publication) | L2_13_GCAS Last-Visit_BGR_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_13_GCAS Screening_BGR_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_14_QOL-AD-Patient_BGR_san | AU1.1 |
| Subject information and informed consent form (for publication) | L2_15_CGI-S_I_ADP_BGR_san | N/A |
| Subject information and informed consent form (for publication) | L2_16_C-VISA_BGR_san | N/A |
| Subject information and informed consent form (for publication) | L2_17_C-SSRS-Baseline-Screening_BGR_san | 1 |
| Subject information and informed consent form (for publication) | L2_17_C-SSRS-SinceLastVisit_BGR_san | 1 |
| Subject information and informed consent form (for publication) | L2_18_WAIS-IV_Administration and Scoring Manual_Coding_BGR_san | 1 |
| Subject information and informed consent form (for publication) | L2_19_BPST-AD Treatment Plan Template_BGR_san | 1 |
| Subject information and informed consent form (for publication) | L2_2_Other subject Information material_eConsent Glossary_BGR_san | V01.1 BGR |
| Subject information and informed consent form (for publication) | L2_20_BPST-AD Caregiver Diary Template_BGR_san | 1 |
| Subject information and informed consent form (for publication) | L2_21_MMSE_Screenshots_BGR_san | 1 |
| Subject information and informed consent form (for publication) | L2_22_EQ-5D-5L-Proxy_Screenshots_BGR_san | 1 |
| Subject information and informed consent form (for publication) | L2_23_Other subject Information material_Patient ID Card_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_24_Other subject Information material_Welcome Brochure_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_3_Other subject Information material_eConsent Video Storyboard_BGR_san | V02 BGR |
| Subject information and informed consent form (for publication) | L2_4_eConsent Submission Letter_BG_san | 4.0 |
| Subject information and informed consent form (for publication) | L2_4_eConsent Submission Letter_EN_san | 4.0 |
| Subject information and informed consent form (for publication) | L2_5_Getting Started Patient-facing landing page_BGR_san | 1.1 |
| Subject information and informed consent form (for publication) | L2_6_IQVIA Complete Consent Security and Privacy Quick Reference Guide_BGR_san | 1.3 |
| Subject information and informed consent form (for publication) | L2_7_IQVIA Complete Consent Participant-Facing Screenshots_BGR_san | 1.3 |
| Subject information and informed consent form (for publication) | L2_8_SAPS H D_BGR_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_9_The UKU Side Effect Rating Scale_BGR_san | N/A |
| Subject information and informed consent form (for publication) | L2_ACP-204-006_ICF Caregiver | 2.0ESP1.0 |
| Subject information and informed consent form (for publication) | L2_Caregiver ICF_san | V2.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_Oznameni o ochrane osobnich udaju_san | CZE-ces1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_Prirucka Pay Portal_san | CZE-ces1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_Uvitaci dopis pro ucastnika_san | CZE-ces1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_Zasady cestovani_san | CZE-ces1.0 |
| Subject information and informed consent form (for publication) | L2_eConsent Security and Privacy Quick Reference Guide _san | V1.3 CZ |
| Subject information and informed consent form (for publication) | L2_eConsent Submission Letter_Italy | V4.0 |
| Subject information and informed consent form (for publication) | L2_eConsent_Getting Started Patient-facing landing page _san | V1.1 Czech |
| Subject information and informed consent form (for publication) | L2_eConsent_Particpant screenshot_san | V1.3 Czech |
| Subject information and informed consent form (for publication) | L2_Glossary | V01.1 |
| Subject information and informed consent form (for publication) | L2_Main GDPR_san | CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Clincierge_Data Protection Consent_san | v1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Clincierge_Travel Policy_san | v1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Clincierge_Welcome Letter_san | v1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ID Card_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Pregnant Partner GDPR_san | CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Pregnant Partner ICF CZE_san | V1.0CZE1.1 |
| Subject information and informed consent form (for publication) | L3_ACP-204-006_ICF Pregnant Partner | V1-0ESP1-0 |
| Subject information and informed consent form (for publication) | L4_Other subject information material_ACP-204-006_Clincierge_Data Protection Notice | v1-0 |
| Subject information and informed consent form (for publication) | L5_Other subject information material_ACP-204-006_Clincierge_Pay Portal Guide | V1-0 |
| Subject information and informed consent form (for publication) | L6_Other subject information material_ACP-204-006_Video Storyboard | 1.0 |
| Subject information and informed consent form (for publication) | L6_Other subject information material_ACP-204-006-Video Storyboard | 1.0 |
| Subject information and informed consent form (for publication) | L7_Other subject information material_ACP-204-206_Glossary | V01 |
| Subject information and informed consent form (for publication) | L8_Other subject information material_ACP-204-206_Consent Privacy Quick Reference Guide | V1-3 |
| Subject information and informed consent form (for publication) | L9_Other subject information material_ACP-204-006_eConsent Sub Letter | 4-0 |
| Subject information and informed consent form (for publication) | List of submitted documents | NA |
| Synopsis of the protocol (for publication) | D1_Full Protocol synopsis_2023-507325-42-00_FR | 4-EU v1.0 |
| Synopsis of the protocol (for publication) | D1_Full Protocol synopsis_2023-507325-42-00_IT | 4-EU v1.0 |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_2023-507325-42-00_BG | 4-EU v1.0 |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_2023-507325-42-00_CZ | 4-EU v1.0 |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_2023-507325-42-00_EN | 4-EU v1.0 |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_2023-507325-42-00_ES | 4-EU v1.0 |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_2023-507325-42-00_FR | 4-EU v1.0 |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_2023-507325-42-00_IT | 4-EU v1.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-08 | Czechia | Acceptable with conditions 2024-05-30
|
2024-05-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-13 | Czechia | Acceptable 2025-05-21
|
2025-05-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-10 | Czechia | Acceptable 2025-05-21
|
2025-06-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-11 | Acceptable | 2025-09-11 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-23 | Acceptable | 2025-09-04 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-29 | Acceptable | 2025-10-10 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-20 | Czechia | Acceptable with conditions 2026-04-13
|
2026-04-13 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-14 | Czechia | Acceptable with conditions 2026-04-13
|
2026-05-14 |